A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations
Parkinson's Disease (Disorder)
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
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
Active Comparator
Experimental
Experimental
Active Comparator
IR CD-LD - Dose Adjustment
IPX203 - Dose Conversion
IPX203 - Double-Blind Maintenance
IR CD-LD - Double -Blind Maintenance
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.