search
Back to results

A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations

Primary Purpose

Parkinson's Disease (Disorder)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IR CD-LD
IPX203 ER CD-LD
Placebo Matching IPX203
Placebo Matching IR CD-LD
Sponsored by
Impax Laboratories, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease (Disorder) focused on measuring Idiopathic Parkinson's Disease, Lewy Body Parkinson's Disease, Paralysis Agitans, Primary Parkinsonism

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female subjects diagnosed at age ≥ 40 years with PD, consistent with the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria and who are being treated with stable regimens of CD-LD but experiencing motor fluctuations.
  • 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 Screening Visit.
  • Negative urine screen for drugs of abuse and negative alcohol breath test at Screening.
  • Hoehn and Yahr Stages 1, 2, 3, or 4 in the "On" state (part of Movement Disorders Society version of the Unified Parkinson's Disease Rating Scale [MDS-UPDRS] Part III)
  • Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study. Medically acceptable methods of contraception that may be used by the subject and/or partner include but are not limited to: abstinence, oral contraception, NuvaRing or transdermal systems, diaphragm with vaginal spermicide, intrauterine device, condom and partner using vaginal spermicide, surgical sterilization (6 months), progestin implant or injection, or postmenopausal female (no menstrual period for ˃ 2 years) or vasectomy (˃ 6 months).
  • Montreal Cognitive Assessment (MoCA) score ≥ 24 at Screening Visit in "On" state.
  • Able to differentiate "On" state from "Off" state as determined by at least 75% concordance with a trained rater in "On/Off" ratings for 8 ratings over a 4-hour training period. The concordance must include at least 1 "On" and 1 "Off" rating and must be achieved within two 4-hour training sessions.
  • Able and willing to comply with the protocol, including completion of diaries and availability for all study visits.
  • Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1.
  • At Screening, the subject has predictable "Off" periods.

Exclusion Criteria:

  • Received any investigational medications within 30 days or 5 times the half-life, whichever is longer, prior to Visit 1.
  • Female subjects who are currently breastfeeding or lactating.
  • Had prior neurosurgical treatment for PD or if such procedure is planned or anticipated during the study period.
  • Allergic to any excipient in the study drugs.
  • History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy, proximal small-bowel resection, or bariatric surgery.
  • History of upper gastrointestinal hemorrhage in patients with peptic ulcer disease within the past 5 years.
  • History of glaucoma with intraocular pressures that are elevated despite appropriate medical management.
  • History of seizure or epilepsy and experienced at least 1 seizure during the past 12 months or has not been compliant with medically recommended therapy or visits.
  • History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and/or surgical interventions. A recent (≤ 12 months) history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control.
  • History of neuroleptic malignant syndrome or of nontraumatic rhabdomyolysis.
  • Liver enzyme values ≥ 2.5 times the upper limit of normal; or history of severe hepatic impairment.
  • Serum creatinine level ≥ 1.75 times the upper limit of normal; or requires dialysis at the time of Screening.
  • Subject with a history of malignant melanoma or with a suspicious undiagnosed skin lesion which in the opinion of the investigator could be melanoma.
  • History of drug or alcohol abuse within the 12 months prior to Screening.
  • Received within 4 weeks of Screening or planning to take during participation in the clinical study:
  • Any doses of a CR CD-LD apart from a single daily bedtime dose, any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo),
  • Nonselective monoamine oxidase inhibitors (MAOI), apomorphine, or antidopaminergic agents, including antiemetics.
  • Employees or family members of the investigator, study site, or sponsor.
  • Subjects who have previously participated in an IPX203 study.
  • Subjects who, in the opinion of the clinical investigator, should not participate in the study.
  • Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD diary.

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)
  • Loma Linda University Health Care, Department of Neurology (137)
  • Keck 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 Center (116)
  • Christiana Care Neurology Specialists (153)
  • JEM Research Institute (136)
  • Visionary Investigators Network (168)
  • University of Miami-UHealth at Boca Raton (152)
  • Parkinson's Disease and Movement Disorders Center of Boca Raton (121)
  • MD Clinical (111)
  • Infinity Clinical Research (104)
  • University of Florida Health Science Center(129)
  • Neurology Associates, P.A. (125)
  • University of Miami (149)
  • Medical Professional Clinical Research Center, INC (163)
  • Parkinsons'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)
  • Struthers Parkinson's Center (130)
  • Washington University (109)
  • Cleveland Clinic Lou Ruvo Center for Brain Health (142)
  • Roseman Medical Research Institute/Roseman Medical Group (154)
  • Albany Medical College (139)
  • Mount Sinai West-Department of Neurology(172)
  • Wake Forest Baptist Health Sciences (127)
  • Ucgni (133)
  • University Hospitals Cleveland Medical Center (123)
  • Cleveland Clinic (144)
  • University of Toledo, Gardner-McMaster Parkinson Center (122)
  • Movement Disorder Clinic of Oklahoma (115)
  • Medical University of South Carolina (150)
  • 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 Medical Group-Neurology I (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)
  • INSERM, Centre d'investigation Clinique 1402, CHU de Poitiers (402)
  • Centre d'Investigation Clinique 1436-CHU Purpan-Hopital Pierre Paul Riquet (403)
  • Curiositas ad sanum, Studien und Beratungs GmbH(311)
  • Klinikum rechts der lsar der TUM, Klinik und Poliklinik fur Neurologie (303)
  • Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus fUr Bewegungsstorungen/Parkinson (300)
  • Gemeinschaftspraxis Dr. med. Joachim Springub/ Wolfgang Schwarz, Studienzentrum Nord-West (306)
  • St. Josef-Hospital, Universitatsklinik fur Neurologie, Klinisches Forschungszentrum fur Neurodegeneration (301)
  • Klinik Haag i. OB, Geriatric Hospital (305)
  • Universitatsklinikum Carl Gustav Carus, Klinik und Poliklinik fur Neurologie (307)
  • Dr. med. REINHARDT Ehret Neurologie Berlin Schlobstr. 29 (309)
  • Department "G.F. Ingrassia" Section of neuroscience-Policlinico "Vittorio Emanuele" (608)
  • Universita G. D'annunzio CeSi Met (604)
  • Centro Ricerca Parkinson San Raffaele Cassino (601)
  • Fondazione lstituto Neurologico Nazionale "C. Mondino" (606)
  • Azienda Ospedaliero-Universitaria Pisana (602)
  • University of Rome Tor Vergata/Hospital Tor Vergata (605)
  • IRCCS San Raffaele Pisana (600)
  • Department of Neuroscience, Mental Health and Sensory System (NeSMOS), Sapienza University (603)
  • Centrum Medyczne Neuromed (803)
  • Szpital Sw. Rozy (805)
  • Krakowska Akademia Neurologii Sp. z o.o.(802)
  • NZOZ Neuromed M. i M Nastaj Spolka Partnerska(800)
  • NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)
  • Neuro-Care Sp. z o.o. sp. k.(804)
  • Centrum Medyczne NeuroProtect (806)
  • Hospital Genral 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)
  • Hospital Universitario Vall d' Hebron (505)
  • Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)
  • Hospital Clinic de Barcelona (507)
  • Hospital De La Santa Creu i Sant Pau (502)
  • Hospital Universitario de la 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 (515)
  • Re: Cognition Health Ltd(205)
  • Re:Cognition Health Ltd (202)
  • Imperial College Healthcare NHS Trust (200)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

IR CD-LD - Dose Adjustment

IPX203 - Dose Conversion

IPX203 - Double-Blind Maintenance

IR CD-LD - Double -Blind Maintenance

Arm Description

Participants started on the same dose as the pre-study dosing regimen of IR CD-LD and then received dose adjusted IR CD-LD tablets daily orally, for a period of 3 weeks. If the participant was taking controlled release carbidopa-levodopa (CR CD-LD), the CR CD-LD was discontinued and substituted with a 1:1 milligram-equivalent dose of IR CD-LD.

Participants received extended release (ER) CD-LD (IPX203) capsules orally, every 6 - 12 hours for a period of 4 weeks at a dose based on their most frequent stable dose of IR CD-LD in dose adjustment period. Participant with most frequent stable dose of 25-100 milligrams (mg) IR CD-LD received 70 - 280 mg IPX203 thrice daily (TID); >25-100 - 37.5-150 mg IR CD-LD received 105-420 mg IPX203 TID; >37.5-150 - 50-200 mg IR CD-LD received 140-560 mg IPX203 TID; >50 - 200 mg IR CD-LD received 175-700 mg IPX203 TID. Participants who received a daily total dose of less than 125-500 mg IR CD-LD in dose adjustment received IPX203 every 12 hours. After initial dose conversion from IR CD-LD to IPX203 as per above mentioned dose conversion schedule, the dose of IPX203 could be further adjusted during the 4 week dose conversion period.

Participants received IPX203 capsules orally, every 6 - 12 hours for 13 weeks at a stable dose established at the end of dose conversion period along with placebo matched to IR CD-LD.

Participants received IR CD-LD tablets daily orally, for 13 weeks at a stable dose established at the end of dose adjustment period along with placebo matched to IPX203.

Outcomes

Primary Outcome Measures

Mean Change From Baseline in "Good on" Time Per Day at Week 20/Early Termination (ET)
"Good on" time was derived from the 3-day PD Diaries. For each day, "Good on" time was calculated by adding the number of half-hour intervals in which either an "On" without dyskinesia or "On" with nontroublesome dyskinesia was checked. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization. Least square mean (LSM), standard error (SE), confidence interval (CI), Mixed model repeated measures (MMRM), Change from baseline (CFB).

Secondary Outcome Measures

Change From Baseline in "Off" Time Per Day at Week 20/ET
"Off" time was derived from the 3-day PD Diaries. For each day, "Off" time was calculated by adding the number of half-hour intervals in which the Status "Off" was checked. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization.
Percentage of Participants With Either "Much Improved" or "Very Much Improved" in Patient Global Impression of Change (PGI-C) Scores at Week 20/ET
The Patient Global Impression of Change (PGIC) is self assessment questionnaire which was used by participants to compare his/her condition on a 7-point scale ranging from 1-Very Much Worse, 2-Much Worse, 3-Minimally Worse, 4-No Change, 5-Minimally Improved, 6-Much Improved, 7-Very Much Improved. Percentage of participants with either "Much Improved" or "Very Much Improved" was reported.
Change From Baseline in The Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at Week 20/ET
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; 34 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 0-234). Part III score ranges from 0 to 136. A higher score indicated more severe symptoms of PD. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization.
Change From Baseline in The Sum of MDS-UPDRS Part II and Part III at Week 20/ET
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; 34 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 0-234). The scale range for Part II+III score is 0-188. A higher score indicated more severe symptoms of PD. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization.

Full Information

First Posted
September 12, 2018
Last Updated
January 16, 2023
Sponsor
Impax Laboratories, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03670953
Brief Title
A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations
Official Title
A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (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
To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.
Detailed Description
This was a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study. The study consisted of a 3-week, open-label IR CD-LD dose adjustment period; a 4-week, open-label period for conversion to IPX203; followed by a 13-week double-blind treatment period with participants randomized in a 1:1 ratio, stratified by center, to receive either IPX203 (with matching IR CD-LD placebo) or IR CD-LD (with matching IPX203 placebo).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease (Disorder)
Keywords
Idiopathic Parkinson's Disease, Lewy Body Parkinson's Disease, Paralysis Agitans, Primary Parkinsonism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double dummy, blinded drug
Allocation
Randomized
Enrollment
630 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IR CD-LD - Dose Adjustment
Arm Type
Active Comparator
Arm Description
Participants started on the same dose as the pre-study dosing regimen of IR CD-LD and then received dose adjusted IR CD-LD tablets daily orally, for a period of 3 weeks. If the participant was taking controlled release carbidopa-levodopa (CR CD-LD), the CR CD-LD was discontinued and substituted with a 1:1 milligram-equivalent dose of IR CD-LD.
Arm Title
IPX203 - Dose Conversion
Arm Type
Experimental
Arm Description
Participants received extended release (ER) CD-LD (IPX203) capsules orally, every 6 - 12 hours for a period of 4 weeks at a dose based on their most frequent stable dose of IR CD-LD in dose adjustment period. Participant with most frequent stable dose of 25-100 milligrams (mg) IR CD-LD received 70 - 280 mg IPX203 thrice daily (TID); >25-100 - 37.5-150 mg IR CD-LD received 105-420 mg IPX203 TID; >37.5-150 - 50-200 mg IR CD-LD received 140-560 mg IPX203 TID; >50 - 200 mg IR CD-LD received 175-700 mg IPX203 TID. Participants who received a daily total dose of less than 125-500 mg IR CD-LD in dose adjustment received IPX203 every 12 hours. After initial dose conversion from IR CD-LD to IPX203 as per above mentioned dose conversion schedule, the dose of IPX203 could be further adjusted during the 4 week dose conversion period.
Arm Title
IPX203 - Double-Blind Maintenance
Arm Type
Experimental
Arm Description
Participants received IPX203 capsules orally, every 6 - 12 hours for 13 weeks at a stable dose established at the end of dose conversion period along with placebo matched to IR CD-LD.
Arm Title
IR CD-LD - Double -Blind Maintenance
Arm Type
Active Comparator
Arm Description
Participants received IR CD-LD tablets daily orally, for 13 weeks at a stable dose established at the end of dose adjustment period along with placebo matched to IPX203.
Intervention Type
Drug
Intervention Name(s)
IR CD-LD
Other Intervention Name(s)
Generic for Sinemet tablets
Intervention Description
Active comparator - IR CD-LD
Intervention Type
Drug
Intervention Name(s)
IPX203 ER CD-LD
Intervention Description
Investigational formulation - ER CD-LD
Intervention Type
Other
Intervention Name(s)
Placebo Matching IPX203
Intervention Description
Double dummy placebo capsules
Intervention Type
Other
Intervention Name(s)
Placebo Matching IR CD-LD
Intervention Description
Double dummy placebo tablets
Primary Outcome Measure Information:
Title
Mean Change From Baseline in "Good on" Time Per Day at Week 20/Early Termination (ET)
Description
"Good on" time was derived from the 3-day PD Diaries. For each day, "Good on" time was calculated by adding the number of half-hour intervals in which either an "On" without dyskinesia or "On" with nontroublesome dyskinesia was checked. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization. Least square mean (LSM), standard error (SE), confidence interval (CI), Mixed model repeated measures (MMRM), Change from baseline (CFB).
Time Frame
Baseline (Week 7) and Week 20/ET
Secondary Outcome Measure Information:
Title
Change From Baseline in "Off" Time Per Day at Week 20/ET
Description
"Off" time was derived from the 3-day PD Diaries. For each day, "Off" time was calculated by adding the number of half-hour intervals in which the Status "Off" was checked. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization.
Time Frame
Baseline (Week 7) and Week 20/ET
Title
Percentage of Participants With Either "Much Improved" or "Very Much Improved" in Patient Global Impression of Change (PGI-C) Scores at Week 20/ET
Description
The Patient Global Impression of Change (PGIC) is self assessment questionnaire which was used by participants to compare his/her condition on a 7-point scale ranging from 1-Very Much Worse, 2-Much Worse, 3-Minimally Worse, 4-No Change, 5-Minimally Improved, 6-Much Improved, 7-Very Much Improved. Percentage of participants with either "Much Improved" or "Very Much Improved" was reported.
Time Frame
Week 20/ET
Title
Change From Baseline in The Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at Week 20/ET
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; 34 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 0-234). Part III score ranges from 0 to 136. A higher score indicated more severe symptoms of PD. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization.
Time Frame
Baseline (Week 7) and Week 20/ET
Title
Change From Baseline in The Sum of MDS-UPDRS Part II and Part III at Week 20/ET
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; 34 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 0-234). The scale range for Part II+III score is 0-188. A higher score indicated more severe symptoms of PD. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization.
Time Frame
Baseline (Week 7) and Week 20/ET

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female participants diagnosed at age ≥ 40 years with PD, consistent with the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria and who are being treated with stable regimens of CD-LD but experiencing motor fluctuations. 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 Screening Visit. Negative urine screen for drugs of abuse and negative alcohol breath test at Screening. Hoehn and Yahr Stages 1, 2, 3, or 4 in the "On" state (part of Movement Disorders Society version of the Unified Parkinson's Disease Rating Scale [MDS-UPDRS] Part III) Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study. Medically acceptable methods of contraception that may be used by the participant and/or partner include but are not limited to: abstinence, oral contraception, NuvaRing or transdermal systems, diaphragm with vaginal spermicide, intrauterine device, condom and partner using vaginal spermicide, surgical sterilization (6 months), progestin implant or injection, or postmenopausal female (no menstrual period for ˃ 2 years) or vasectomy (˃ 6 months). Montreal Cognitive Assessment (MoCA) score ≥ 24 at Screening Visit in "On" state. Able to differentiate "On" state from "Off" state as determined by at least 75% concordance with a trained rater in "On/Off" ratings for 8 ratings over a 4-hour training period. The concordance must include at least 1 "On" and 1 "Off" rating and must be achieved within two 4-hour training sessions. Able and willing to comply with the protocol, including completion of diaries and availability for all study visits. Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1. At Screening, the participant has predictable "Off" periods. Exclusion Criteria: Received any investigational medications within 30 days or 5 times the half-life, whichever is longer, prior to Visit 1. Female participants who are currently breastfeeding or lactating. Had prior neurosurgical treatment for PD or if such procedure is planned or anticipated during the study period. Allergic to any excipient in the study drugs. History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy, proximal small-bowel resection, or bariatric surgery. History of upper gastrointestinal hemorrhage in participants with peptic ulcer disease within the past 5 years. History of glaucoma with intraocular pressures that are elevated despite appropriate medical management. History of seizure or epilepsy and experienced at least 1 seizure during the past 12 months or has not been compliant with medically recommended therapy or visits. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and/or surgical interventions. A recent (≤ 12 months) history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control. History of neuroleptic malignant syndrome or of nontraumatic rhabdomyolysis. Liver enzyme values ≥ 2.5 times the upper limit of normal; or history of severe hepatic impairment. Serum creatinine level ≥ 1.75 times the upper limit of normal; or requires dialysis at the time of Screening. Participant with a history of malignant melanoma or with a suspicious undiagnosed skin lesion which in the opinion of the investigator could be melanoma. History of drug or alcohol abuse within the 12 months prior to Screening. Received within 4 weeks of Screening or planning to take during participation in the clinical study: Any doses of a CR CD-LD apart from a single daily bedtime dose, any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo), Nonselective monoamine oxidase inhibitors (MAOI), apomorphine, or antidopaminergic agents, including antiemetics. Employees or family members of the investigator, study site, or sponsor. Participants who have previously participated in an IPX203 study. Participants who, in the opinion of the clinical investigator, should not participate in the study. Based on clinical assessment, participant does not adequately comprehend the terminology needed to complete the PD diary.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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
Loma Linda University Health Care, Department of Neurology (137)
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Keck 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 Center (116)
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Christiana Care 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
University of Miami-UHealth at Boca Raton (152)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33131
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
MD Clinical (111)
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Infinity Clinical Research (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
Parkinsons'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
33613
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
483222
Country
United States
Facility Name
Struthers Parkinson's Center (130)
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
Facility Name
Washington University (109)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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
Roseman Medical Research Institute/Roseman Medical Group (154)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89118
Country
United States
Facility Name
Albany Medical College (139)
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Mount Sinai West-Department of Neurology(172)
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Wake Forest Baptist Health Sciences (127)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
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
Movement Disorder Clinic of Oklahoma (115)
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Medical University of South Carolina (150)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
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 Medical Group-Neurology I (147)
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22311
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
160 00
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
INSERM, Centre d'investigation Clinique 1402, CHU de Poitiers (402)
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Centre d'Investigation Clinique 1436-CHU Purpan-Hopital Pierre Paul Riquet (403)
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Curiositas ad sanum, Studien und Beratungs GmbH(311)
City
München
State/Province
Bavaria
ZIP/Postal Code
80331
Country
Germany
Facility Name
Klinikum rechts der lsar der TUM, Klinik und Poliklinik fur Neurologie (303)
City
München
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Facility Name
Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus fUr Bewegungsstorungen/Parkinson (300)
City
Beelitz-Heilstatten
State/Province
Brandenburg
ZIP/Postal Code
14547
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. Joachim Springub/ Wolfgang Schwarz, Studienzentrum Nord-West (306)
City
Westerstede
State/Province
Lower Saxony
ZIP/Postal Code
26655
Country
Germany
Facility Name
St. Josef-Hospital, Universitatsklinik fur Neurologie, Klinisches Forschungszentrum fur Neurodegeneration (301)
City
Bochum
State/Province
North Rhine-Westphalia
ZIP/Postal Code
44791
Country
Germany
Facility Name
Klinik Haag i. OB, Geriatric Hospital (305)
City
Haag In Oberbayern
State/Province
Oberbayern (Upper Bavaria)
ZIP/Postal Code
83527
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus, Klinik und Poliklinik fur Neurologie (307)
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Facility Name
Dr. med. REINHARDT Ehret Neurologie Berlin Schlobstr. 29 (309)
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
Department "G.F. Ingrassia" Section of neuroscience-Policlinico "Vittorio Emanuele" (608)
City
Catania
State/Province
Italy/Catania/Sicily
ZIP/Postal Code
95123
Country
Italy
Facility Name
Universita G. D'annunzio CeSi Met (604)
City
Chieti
State/Province
Italy/Chieti/Abbruzzo
ZIP/Postal Code
66100
Country
Italy
Facility Name
Centro Ricerca Parkinson San Raffaele Cassino (601)
City
Cassino
State/Province
Italy/Frosinone/Lazio
ZIP/Postal Code
03043
Country
Italy
Facility Name
Fondazione lstituto 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
University of Rome Tor Vergata/Hospital Tor Vergata (605)
City
Roma
State/Province
Italy/Roma/Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
IRCCS San Raffaele Pisana (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
Centrum Medyczne Neuromed (803)
City
Bydgoszcz
ZIP/Postal Code
85-163
Country
Poland
Facility Name
Szpital Sw. Rozy (805)
City
Kraków
ZIP/Postal Code
30-394
Country
Poland
Facility Name
Krakowska Akademia Neurologii Sp. z o.o.(802)
City
Kraków
ZIP/Postal Code
31-505
Country
Poland
Facility Name
NZOZ Neuromed M. i M Nastaj Spolka Partnerska(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
61-853
Country
Poland
Facility Name
Neuro-Care Sp. z o.o. sp. k.(804)
City
Siemianowice Śląskie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect (806)
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Facility Name
Hospital Genral 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
08190
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
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
Hospital Universitario Vall d' Hebron (505)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona (507)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital De La Santa Creu i Sant Pau (502)
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario de la 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 (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
Re:Cognition Health Ltd (202)
City
London
ZIP/Postal Code
W1G9JF
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust (200)
City
London
ZIP/Postal Code
W68RF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations

We'll reach out to this number within 24 hrs