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Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IPX203
Sponsored by
Impax Laboratories, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring motor fluctuations, IPX203

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Successfully completed Study IPX203-B16-02
  • Able to provide written informed consent prior to the conduct of any study-specific procedures.
  • Female subjects of childbearing potential must have a negative urine pregnancy test at the baseline visit (Visit 1).
  • Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study.

Exclusion Criteria:

  • Intends to use any doses of Rytary® or Duopa™ during this study.
  • Plans to use an investigational treatment other than IPX203 during the course of this study.
  • Neurosurgical ablation treatment for PD is planned or anticipated during the study period. Implantation of a deep brain stimulator (DBS) for the treatment of PD is permitted during this study.
  • Subjects who, in the opinion of the clinical investigator, should not participate in the study.

Sites / Locations

  • Xenoscience, Inc (102)
  • St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (156)
  • Clinical Trials, Inc (113)
  • University of Arkansas for Medical Sciences (117)
  • Keek School of Medicine of USC/ University of Southern California (106)
  • Hoag Memorial Hospital Presbyterian (134)
  • SC3 Research-Pasadena (148)
  • SC3 Research-Reseda (146)
  • University of Colorado Hospital Anschutz Outpatient Pavilion (120)
  • Rocky Mountain Movement Disorders (116)
  • ChristianaCare Neurology Specialists (153)
  • JEM Research Institute (136)
  • Visionary Investigators Network (168)
  • UHealth at Boca Raton (152)
  • Parkinson's Disease and Movement Disorders Center of Boca Raton (121)
  • Infinity Clinical Research LLC (104)
  • University of Florida Health Science Center (129)
  • Neurology Associates, P.A. (125)
  • University of Miami (149)
  • Medical Professional Clinical Research Center, Inc. (163)
  • Parkinson's Disease Treatment Center of Southwest Florida (131)
  • Infinity Clinical Research, LLC (105)
  • University of South Florida (114)
  • Premiere Research Institute at Palm Beach Neurology (174)
  • Charter Research (166)
  • Emory Brain Health Center (110)
  • NeuroStudies.net, LLC (155)
  • Northwestern Medical Group Neurology Clinic (145)
  • Central DuPage Hospital (151)
  • Indiana University Health Neuroscience Center(164)
  • University of Kansas Medical Center (118)
  • Quest Research Institute (103)
  • Henry Ford West Bloomfield Hospital(100)
  • Washington University (109)
  • Roseman Medical Research Institute / Roseman Medical Group (154)
  • Cleveland Clinic Lou Ruvo Center for Brain Health (142)
  • Albany Medical College (139)
  • Ucgni (133)
  • University Hospitals Cleveland Medical Center (123)
  • Cleveland Clinic(144)
  • University of Toledo, Gardner-McMaster Parkinson Center (122)
  • The Movement Disorder Clinic of Oklahoma (115)
  • The Vanderbilt Clinic (158)
  • Neurology Consultants of Dallas, PA (108)
  • University of Texas Southwestern Medical Center (143)
  • Houston Methodist Neurological Institute/Movement Disorders Clinic (135)
  • Inova Neurology- Fairfax (147)
  • VCU Health- Neuroscience Orthopaedic and Wellness Center(124)
  • Booth Gardner Parkinson's Care Center (112)
  • Inland Northwest Research (119)
  • Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704)
  • NEUROHK. s.r.o. (701)
  • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702)
  • CLINTRIAL s.r.o. (703)
  • AXON Clinical. s.r.o. (700)
  • Neurologicka ordinace FORBELI s.r.o. (706)
  • CHU de Clermont-Ferrand-Hopital Gabriel Montpied (404)
  • CHU de Montpellier, Hopital Gui de Chauliac (405)
  • Centre Hospitalier Universitaire de Nice (400)
  • Centre d'lnvestigation Clinique 1436- CHU Purpan- Hopital Pierre Paul Riquet (403)
  • Kliniken Beelitz GmbH, neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson (300)
  • St. Josef-Hospital, Universitatsklinik fur Neurologie Klinisches Forschungszentrum fur Neurodegeneration (301)
  • Klinikum rechts der lsar der Technischen Universitat Munchen Klinik und Poliklinik fur Neurologie (303)
  • Dr. med. Reinhardt Ehret Neuroloqie Berlin Schlobstr. 29 (309)
  • Klinik Haag i. OB Geriatric Hospital Krankenhausstrabe 4 (305)
  • Gemeinschaftspraxis Dr. med. J. Springub/W. Schwarz, Studienzentrum Nordwest (306)
  • Centro Ricerca Parkinson San Raffaele Cassino (601)
  • Università G. D'annunzio CeSi Met (604)
  • Fondazione I st ituto Neurologico Nazionale "C. Mondino" (606)
  • Azienda Ospedaliero-Universitaria Pisana (602)
  • IRCCS San Raffaele Pi sana (600)
  • Department of neuroscience, mental health and sensory system (NeSMOS), "Sapienza" University (603)
  • University of Rome Tor Vergata/Hospital Tor Vergata (605)
  • Department "G. F. Ingrassia" section of neuroscience - Policlinico "Vittorio Emanuele" (608)
  • Centrum Medyczne Neuromed (803)
  • Centrum Medyczne Linden (805)
  • Krakowska Akademia Neurologii Sp. Zo.o.(802)
  • NZOZ Neuromed M. i M. Nastaj Sp.p. (800)
  • NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)
  • Neuro-Care Sp. z o.o. sp. k. (804)
  • Centrum Medycme NeuroProtect (806)
  • Hospital General Universitario de Elche (509)
  • Hospital Universitari General de Catalunya (504)
  • Hospital Universitari Mutua Terrassa (506)
  • Policlinica Gipuzkoa, S.A (511)
  • Clinica Universidad de Navarra (512)
  • Hospital Universitario Quiron Dexeus (501)
  • Germanes Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)
  • Hospital Universitario Vall d'Hebron (505)
  • Hospital de Ia Santa Creu i Sant Pau (502)
  • Hospital Universitario de Ia Princesa (508)
  • Hospital Universitario Ramon y Cajal (500)
  • Hospital Universitario Infanta Sofia(513)
  • Hospital Universitario Virgen del Rocio (503)
  • Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell (515)
  • Re:Cognition Health Ltd (205)
  • Imperial College Healthcare NI-lS Trust (200)
  • Re:Cognition Health Ltd (202)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label IPX203

Arm Description

All participants received oral administration of extended-release capsules IPX203 dosing regimen that was determined at the end of the IPX203 dose conversion period of Study IPX203-B16-02 (NCT03670953) for nine months of open-label therapy. The dose and dosing frequency was determined by the investigator to achieve the optimal balance of efficacy and safety.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was considered as treatment-emergent if the date of onset was on or after the date of the first open-label study drug administration in this Study IPX203-B16-03 and no later than 1 day after the last study drug dose in the study.

Secondary Outcome Measures

Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260).
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260).
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part I score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part I score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part II score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part II score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part III score ranges from 0 to 132. A higher score indicated more severe symptoms of PD.
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part III score ranges from 0 to 132. A higher score indicated more severe symptoms of PD.
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part IV score ranges from 0 to 24. A higher score indicated more severe symptoms of PD.
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part IV score ranges from 0 to 24. A higher score indicated more severe symptoms of PD.
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). The scale range for Part II+III score is 0-184. A higher score indicated more severe symptoms of PD.
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). The scale range for Part II+III score is 0-184. A higher score indicated more severe symptoms of PD.
Patient Global Impression of Severity (PGI-S)
The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill.
Change From Baseline in Patient Global Impression of Severity (PGI-S)
The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill.
Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5
The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill.
Clinical Global Impression of Severity (CGI-S)
The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants.
Change From Baseline in Clinical Global Impression of Severity (CGI-S)
The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants.
Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5
The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants.
39-item Parkinson's Disease Questionnaire (PDQ-39): Total
The PDQ-39 is a self-reported outcome of 39 questions relating to 8 domains: mobility (Questions 1-10), activities of daily living (ADL) (Questions 11-16), emotional well-being (Questions 17-22), stigma (Questions 23-26), social support (Questions 27-29), cognition (Questions 30-33), communication (Questions 34-36) and bodily discomfort (Questions 37-39). Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness.
Change From Baseline in PDQ-39: Total
The PDQ-39 is a self-reported outcome of 39 questions relating to 8 domains: mobility (Questions 1-10), activities of daily living (ADL) (Questions 11-16), emotional well-being (Questions 17-22), stigma (Questions 23-26), social support (Questions 27-29), cognition (Questions 30-33), communication (Questions 34-36) and bodily discomfort (Questions 37-39). Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness.
Parkinson Anxiety Scale (PAS): Total
The PAS is a three part participant answered assessment. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Totals for all three parts are summed and ranges from 0 to 48, higher scores are associated with the more severe symptoms.
Change From Baseline in Parkinson Anxiety Scale (PAS): Total
The PAS is a three part participant answered assessment. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Totals for all three parts are summed and ranges from 0 to 48, higher scores are associated with the more severe symptoms.
Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total
The NMSS assesses non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous. Severity symptoms are rated on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score which ranges from 0 to 360 with a lower score more desirable than a higher score.
Change From Baseline in Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total
The NMSS assesses non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous. Severity symptoms are rated on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score which ranges from 0 to 360 with a lower score more desirable than a higher score.
Parkinson's Disease Sleep Scale-2 (PDSS-2) Total
The PDSS-2 is a 15 question participant response scale measuring the severity of sleep disturbance. Three domains are defined: disturbed sleep (Questions 1-3, 8, 14), motor symptoms at night (Questions 4-6, 12, 13), PD symptoms at night (Questions 7, 9-11, 15). Each question is rated as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.
Change From Baseline in Parkinson's Disease Sleep Scale-2 (PDSS-2):Total
The PDSS-2 is a 15 question participant response scale measuring the severity of sleep disturbance. Three domains are defined: disturbed sleep (Questions 1-3, 8, 14), motor symptoms at night (Questions 4-6, 12, 13), PD symptoms at night (Questions 7, 9-11, 15). Each question is rated as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.
Treatment Satisfaction Assessment (TSA)
The TSA is a participant answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 = Very much dissatisfied being least satisfied and 7 = Very much satisfied.
Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral)
The TSA is a participant answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 = Very much dissatisfied being least satisfied and 7 = Very much satisfied.

Full Information

First Posted
March 12, 2019
Last Updated
June 30, 2023
Sponsor
Impax Laboratories, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03877510
Brief Title
Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations
Official Title
An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
March 21, 2022 (Actual)
Study Completion Date
March 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Impax Laboratories, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of participants with advanced Parkinson's disease (PD) who have motor fluctuations.
Detailed Description
This is a 9-month, multicenter open-label safety extension study. Participants who have successfully completed Study NCT03670953 [A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release (IR) Carbidopa-Levodopa (CD-LD) in Parkinson's Disease Patients with Motor Fluctuations] may have the opportunity to enroll in this open-label study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
motor fluctuations, IPX203

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label IPX203
Arm Type
Experimental
Arm Description
All participants received oral administration of extended-release capsules IPX203 dosing regimen that was determined at the end of the IPX203 dose conversion period of Study IPX203-B16-02 (NCT03670953) for nine months of open-label therapy. The dose and dosing frequency was determined by the investigator to achieve the optimal balance of efficacy and safety.
Intervention Type
Drug
Intervention Name(s)
IPX203
Intervention Description
IPX203 extended release capsules
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events
Description
An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was considered as treatment-emergent if the date of onset was on or after the date of the first open-label study drug administration in this Study IPX203-B16-03 and no later than 1 day after the last study drug dose in the study.
Time Frame
From first dose up to 1 day after last dose (Up to 9 months/Early Termination [ET])
Secondary Outcome Measure Information:
Title
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total
Description
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260).
Time Frame
Baseline, Month 3, Month 6, and Month 9/ET
Title
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total
Description
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260).
Time Frame
Baseline, Month 9/ET
Title
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I
Description
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part I score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.
Time Frame
Baseline, Month 3, Month 6, and Month 9/ET
Title
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I
Description
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part I score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.
Time Frame
Baseline, Month 9/ET
Title
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II
Description
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part II score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.
Time Frame
Baseline, Month 3, Month 6, and Month 9/ET
Title
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II
Description
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part II score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.
Time Frame
Baseline, Month 9/ET
Title
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III
Description
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part III score ranges from 0 to 132. A higher score indicated more severe symptoms of PD.
Time Frame
Baseline, Month 3, Month 6, and Month 9/ET
Title
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III
Description
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part III score ranges from 0 to 132. A higher score indicated more severe symptoms of PD.
Time Frame
Baseline, Month 9/ET
Title
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV
Description
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part IV score ranges from 0 to 24. A higher score indicated more severe symptoms of PD.
Time Frame
Baseline, Month 3, Month 6, and Month 9/ET
Title
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV
Description
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part IV score ranges from 0 to 24. A higher score indicated more severe symptoms of PD.
Time Frame
Baseline, Month 9/ET
Title
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III
Description
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). The scale range for Part II+III score is 0-184. A higher score indicated more severe symptoms of PD.
Time Frame
Baseline, Month 3, Month 6, and Month 9/ET
Title
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III
Description
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). The scale range for Part II+III score is 0-184. A higher score indicated more severe symptoms of PD.
Time Frame
Baseline, Month 9/ET
Title
Patient Global Impression of Severity (PGI-S)
Description
The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill.
Time Frame
Baseline, Month 3, Month 6, and Month 9/ET
Title
Change From Baseline in Patient Global Impression of Severity (PGI-S)
Description
The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill.
Time Frame
Baseline, Month 9/ET
Title
Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5
Description
The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill.
Time Frame
Baseline, Month 3, Month 6, and Month 9/ET
Title
Clinical Global Impression of Severity (CGI-S)
Description
The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants.
Time Frame
Baseline, Month 3, Month 6, Month 9/ET
Title
Change From Baseline in Clinical Global Impression of Severity (CGI-S)
Description
The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants.
Time Frame
Baseline, Month 9/ET
Title
Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5
Description
The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants.
Time Frame
Baseline, Month 3, Month 6, and Month 9/ET
Title
39-item Parkinson's Disease Questionnaire (PDQ-39): Total
Description
The PDQ-39 is a self-reported outcome of 39 questions relating to 8 domains: mobility (Questions 1-10), activities of daily living (ADL) (Questions 11-16), emotional well-being (Questions 17-22), stigma (Questions 23-26), social support (Questions 27-29), cognition (Questions 30-33), communication (Questions 34-36) and bodily discomfort (Questions 37-39). Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness.
Time Frame
Baseline, Month 3, Month 6, and Month 9/ET
Title
Change From Baseline in PDQ-39: Total
Description
The PDQ-39 is a self-reported outcome of 39 questions relating to 8 domains: mobility (Questions 1-10), activities of daily living (ADL) (Questions 11-16), emotional well-being (Questions 17-22), stigma (Questions 23-26), social support (Questions 27-29), cognition (Questions 30-33), communication (Questions 34-36) and bodily discomfort (Questions 37-39). Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness.
Time Frame
Baseline, Month 9/ET
Title
Parkinson Anxiety Scale (PAS): Total
Description
The PAS is a three part participant answered assessment. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Totals for all three parts are summed and ranges from 0 to 48, higher scores are associated with the more severe symptoms.
Time Frame
Baseline, Month 3, Month 6, and Month 9/ET
Title
Change From Baseline in Parkinson Anxiety Scale (PAS): Total
Description
The PAS is a three part participant answered assessment. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Totals for all three parts are summed and ranges from 0 to 48, higher scores are associated with the more severe symptoms.
Time Frame
Baseline, Month 9/ET
Title
Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total
Description
The NMSS assesses non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous. Severity symptoms are rated on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score which ranges from 0 to 360 with a lower score more desirable than a higher score.
Time Frame
Baseline, Month 3, Month 6, and Month 9/ET
Title
Change From Baseline in Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total
Description
The NMSS assesses non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous. Severity symptoms are rated on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score which ranges from 0 to 360 with a lower score more desirable than a higher score.
Time Frame
Baseline, Month 9/ET
Title
Parkinson's Disease Sleep Scale-2 (PDSS-2) Total
Description
The PDSS-2 is a 15 question participant response scale measuring the severity of sleep disturbance. Three domains are defined: disturbed sleep (Questions 1-3, 8, 14), motor symptoms at night (Questions 4-6, 12, 13), PD symptoms at night (Questions 7, 9-11, 15). Each question is rated as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.
Time Frame
Baseline, Month 3, Month 6, and Month 9/ET
Title
Change From Baseline in Parkinson's Disease Sleep Scale-2 (PDSS-2):Total
Description
The PDSS-2 is a 15 question participant response scale measuring the severity of sleep disturbance. Three domains are defined: disturbed sleep (Questions 1-3, 8, 14), motor symptoms at night (Questions 4-6, 12, 13), PD symptoms at night (Questions 7, 9-11, 15). Each question is rated as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.
Time Frame
Baseline, Month 9/ET
Title
Treatment Satisfaction Assessment (TSA)
Description
The TSA is a participant answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 = Very much dissatisfied being least satisfied and 7 = Very much satisfied.
Time Frame
Month 3, Month 6 and Month 9/ET
Title
Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral)
Description
The TSA is a participant answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 = Very much dissatisfied being least satisfied and 7 = Very much satisfied.
Time Frame
Month 3, Month 6, and Month 9/ET

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Successfully completed Study IPX203-B16-02 Able to provide written informed consent prior to the conduct of any study-specific procedures. Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit (Visit 1). Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study. Exclusion Criteria: Intends to use any doses of Rytary® or Duopa™ during this study. Plans to use an investigational treatment other than IPX203 during the course of this study. Neurosurgical ablation treatment for PD is planned or anticipated during the study period. Implantation of a deep brain stimulator (DBS) for the treatment of PD is permitted during this study. Participants who, in the opinion of the clinical investigator, should not participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Impax Impax Study Director
Organizational Affiliation
Impax Laboratories, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Xenoscience, Inc (102)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (156)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Clinical Trials, Inc (113)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of Arkansas for Medical Sciences (117)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Keek School of Medicine of USC/ University of Southern California (106)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian (134)
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
SC3 Research-Pasadena (148)
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
SC3 Research-Reseda (146)
City
Reseda
State/Province
California
ZIP/Postal Code
91335
Country
United States
Facility Name
University of Colorado Hospital Anschutz Outpatient Pavilion (120)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Movement Disorders (116)
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
ChristianaCare Neurology Specialists (153)
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
JEM Research Institute (136)
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Visionary Investigators Network (168)
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
UHealth at Boca Raton (152)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton (121)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Infinity Clinical Research LLC (104)
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
University of Florida Health Science Center (129)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Neurology Associates, P.A. (125)
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
University of Miami (149)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Medical Professional Clinical Research Center, Inc. (163)
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Parkinson's Disease Treatment Center of Southwest Florida (131)
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Infinity Clinical Research, LLC (105)
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
University of South Florida (114)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Premiere Research Institute at Palm Beach Neurology (174)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Charter Research (166)
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Emory Brain Health Center (110)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
NeuroStudies.net, LLC (155)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Northwestern Medical Group Neurology Clinic (145)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Central DuPage Hospital (151)
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Indiana University Health Neuroscience Center(164)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center (118)
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Quest Research Institute (103)
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Henry Ford West Bloomfield Hospital(100)
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Washington University (109)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Roseman Medical Research Institute / Roseman Medical Group (154)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
17601
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Center for Brain Health (142)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Albany Medical College (139)
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Ucgni (133)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals Cleveland Medical Center (123)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic(144)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Toledo, Gardner-McMaster Parkinson Center (122)
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
The Movement Disorder Clinic of Oklahoma (115)
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
The Vanderbilt Clinic (158)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Neurology Consultants of Dallas, PA (108)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
University of Texas Southwestern Medical Center (143)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9184
Country
United States
Facility Name
Houston Methodist Neurological Institute/Movement Disorders Clinic (135)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Inova Neurology- Fairfax (147)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
17601
Country
United States
Facility Name
VCU Health- Neuroscience Orthopaedic and Wellness Center(124)
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Booth Gardner Parkinson's Care Center (112)
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Inland Northwest Research (119)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704)
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
NEUROHK. s.r.o. (701)
City
Choceň
ZIP/Postal Code
56501
Country
Czechia
Facility Name
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702)
City
Pardubice
ZIP/Postal Code
53203
Country
Czechia
Facility Name
CLINTRIAL s.r.o. (703)
City
Praha 10
ZIP/Postal Code
10000
Country
Czechia
Facility Name
AXON Clinical. s.r.o. (700)
City
Praha 5
ZIP/Postal Code
15000
Country
Czechia
Facility Name
Neurologicka ordinace FORBELI s.r.o. (706)
City
Praha 6
ZIP/Postal Code
16000
Country
Czechia
Facility Name
CHU de Clermont-Ferrand-Hopital Gabriel Montpied (404)
City
Clermont-Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
CHU de Montpellier, Hopital Gui de Chauliac (405)
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hospitalier Universitaire de Nice (400)
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Centre d'lnvestigation Clinique 1436- CHU Purpan- Hopital Pierre Paul Riquet (403)
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Kliniken Beelitz GmbH, neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson (300)
City
Beelitz-Heilstätten
State/Province
Beelitz
ZIP/Postal Code
14547
Country
Germany
Facility Name
St. Josef-Hospital, Universitatsklinik fur Neurologie Klinisches Forschungszentrum fur Neurodegeneration (301)
City
Bochum
State/Province
Gudrunstabe 56
ZIP/Postal Code
44791
Country
Germany
Facility Name
Klinikum rechts der lsar der Technischen Universitat Munchen Klinik und Poliklinik fur Neurologie (303)
City
München
State/Province
Ismaningerstrabe
ZIP/Postal Code
81675
Country
Germany
Facility Name
Dr. med. Reinhardt Ehret Neuroloqie Berlin Schlobstr. 29 (309)
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
Klinik Haag i. OB Geriatric Hospital Krankenhausstrabe 4 (305)
City
Haag In Oberbayern
ZIP/Postal Code
83527
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. J. Springub/W. Schwarz, Studienzentrum Nordwest (306)
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Centro Ricerca Parkinson San Raffaele Cassino (601)
City
Cassino
State/Province
Frosinone
ZIP/Postal Code
03043
Country
Italy
Facility Name
Università G. D'annunzio CeSi Met (604)
City
Chieti
State/Province
Italy/Chieti/Abbruzzo
ZIP/Postal Code
66100
Country
Italy
Facility Name
Fondazione I st ituto Neurologico Nazionale "C. Mondino" (606)
City
Pavia
State/Province
Italy/Pavia/Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana (602)
City
Pisa
State/Province
Italy/Pisa/Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
IRCCS San Raffaele Pi sana (600)
City
Roma
State/Province
Italy/Roma/Lazio
ZIP/Postal Code
00163
Country
Italy
Facility Name
Department of neuroscience, mental health and sensory system (NeSMOS), "Sapienza" University (603)
City
Roma
State/Province
Italy/Roma/Lazio
ZIP/Postal Code
00189
Country
Italy
Facility Name
University of Rome Tor Vergata/Hospital Tor Vergata (605)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Department "G. F. Ingrassia" section of neuroscience - Policlinico "Vittorio Emanuele" (608)
City
Catania
State/Province
Sicily
ZIP/Postal Code
95123
Country
Italy
Facility Name
Centrum Medyczne Neuromed (803)
City
Bydgoszcz
ZIP/Postal Code
85163
Country
Poland
Facility Name
Centrum Medyczne Linden (805)
City
Kraków
ZIP/Postal Code
30721
Country
Poland
Facility Name
Krakowska Akademia Neurologii Sp. Zo.o.(802)
City
Kraków
ZIP/Postal Code
31-505
Country
Poland
Facility Name
NZOZ Neuromed M. i M. Nastaj Sp.p. (800)
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Facility Name
NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)
City
Poznań
ZIP/Postal Code
61853
Country
Poland
Facility Name
Neuro-Care Sp. z o.o. sp. k. (804)
City
Siemianowice Śląskie
ZIP/Postal Code
41100
Country
Poland
Facility Name
Centrum Medycme NeuroProtect (806)
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Facility Name
Hospital General Universitario de Elche (509)
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitari General de Catalunya (504)
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Hospital Universitari Mutua Terrassa (506)
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08222
Country
Spain
Facility Name
Policlinica Gipuzkoa, S.A (511)
City
Donostia San Sebastian
State/Province
Gipuzkoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Clinica Universidad de Navarra (512)
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Quiron Dexeus (501)
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Germanes Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron (505)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de Ia Santa Creu i Sant Pau (502)
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario de Ia Princesa (508)
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal (500)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Infanta Sofia(513)
City
Madrid
ZIP/Postal Code
28703
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio (503)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell (515)
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Re:Cognition Health Ltd (205)
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL68BT
Country
United Kingdom
Facility Name
Imperial College Healthcare NI-lS Trust (200)
City
London
ZIP/Postal Code
W68RF
Country
United Kingdom
Facility Name
Re:Cognition Health Ltd (202)
City
London
ZIP/Postal Code
WlG9JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations

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