A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease (APEX-PD)
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease
Eligibility Criteria
Inclusion Criteria:
- Able to understand and willing to voluntarily sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization or local equivalent if applicable.
- Diagnosed with idiopathic PD.
- LD-naïve: defined as subjects not exposed to LD or catechol-O-methyl transferase inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study enrollment.
- If currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type B (MAO-B) inhibitor, maintains a stable regimen for at least 4 weeks prior to Baseline, and agrees to maintain the stable regimen throughout study participation.
- Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
- Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.
Exclusion Criteria:
- Pregnant or breastfeeding.
- Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.
- Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation.
- Use of nonselective MAO inhibitors.
- Use of dopamine agonists within 30 days prior to Screening.
- Unable to tolerate a placebo regimen, in the Investigator's opinion.
- Treatment of psychosis with any antipsychotic.
- History of seizure or epilepsy.
- Active or prior medical condition or prior surgical procedure that would interfere with LD absorption.
- History of narrow-angle glaucoma.
- Subjects with a history of malignant melanoma.
- History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
- Received any investigational medications during the 30 days prior to Screening.
Sites / Locations
- University of Alabama at Birmingham, Dept. of Neurology
- HOPE Research Institute, LLC
- Collaborative NeuroScience Network, Inc.
- Coastal Neurological Medical Group
- Coordinated Clinical Research
- The Parkinson's Institute
- Yale Neurology Clinics, Temple Medical Center
- Bradenton Research Center, Inc.
- Sunrise Clinical Research, Inc.
- Renstar Medical Research
- Charlotte Neurological Services
- Suncoast Neuroscience Associates, Inc.
- University of South Florida
- Idaho Elks Rehabilitation Hospital
- Rush University Medical Center, Dept. of Neurological Sciences
- Landon Center on Aging, Dept. of Neurology, Parkinson's Disease Center
- Boston University School of Medicine
- Quest Research Institute
- Struthers Parkinson's Center
- UMDNJ Robert Wood Johnson Medical Center, Department of Neurology
- Mount Sinai School of Medicine
- Columbia University
- State University of New York Upstate Medical University, Dept. of Neurology
- Duke University Medical Center Movement Disorders Center
- University of Toledo
- Baylor College of Medicine, Parkinson's Disease Center
- Wisconsin Institute for Neurologic and Sleep Disorders
- Movement Disorders Clinic, Glenrose Rehabilitation Hospital
- Saint Boniface Clinic
- London Health Science Center
- Parkinson's and Neurodegenerative Disorders Clinic
- Ottawa Hospital Civic Site
- Toronto Western Hospital
- University of Sherbrooke
- Memory and Motor Skills Clinic
- East Tallinn Central Hospital
- West Tallin Central Hopsital
- P.Stradina university hospital
- Gailezers hospital
- Kaunas Medical University Hospital
- Siauliai Regional Hospital
- Vilnius University Emergency Hospital
- Vilnius University Centre of Gerontology and Rehabilitation
- Vilnius University Hospital Santariskiu klinikos
- Psychiatry and Neurology Hospital, Neurology Department
- Colentina Clinical Hospital Bucharest, II Neurology Department
- County Emergency Clinical Hospital Cluj-Napoca, I Neurology Clinic
- CFR Clinical Hospital Constanta
- Clinical Rehabilitation Hospital Iasi, Neurology Department
- County Clinical Emergency Hospital, Targu Mures, II Neurology Department,
- County Clinical Emergency Hospital Timisoara
- Neurology department of Regional hospital named after Mechnikov
- Department of Psychiatry and Medical Psychology of Donetsk National Medical University
- Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University
- 1st neurology department of Central Clinical Hospital of Ukrzaliznytsya
- Institute of Gerontology Parkinson's Disease Center
- Neurology department of Lviv regional clinical hospital
- Neurology department of Medical Dental Academy based on Poltava regional hospital
- Neurology department of Vinnitsa Medical University
- Neurology department, Zaporozhye State Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
Placebo
IPX066 145 mg LD
IPX066 245 mg LD
IPX066 390 mg LD
One Placebo capsule was given TID for the first 21 days. Two placebo capsules were given TID on days 22 till end of study (week 30).
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-21. One IPX066 145 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. One IPX066 245 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. Two IPX066 195 mg LD capsules were given TID on days 22 till end of study (week 30).