Clinical trial NCT00880620: A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
Official title: A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Lead sponsor: Impax Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2009-04-14
Enrollment: 381
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.

Detailed description: A randomized, double-blind, placebo-controlled, fixed-dose, parallel-arm study of three doses of IPX066 versus placebo.

Total of 427 subjects were screened and 381 were randomized and received one of the four treatment groups (1) placebo (N=92), (2) IPX066 145 mg LD (N=87) (3) IPX066 245 mg LD (N=104) (4) IPX066 390 mg LD (N=98) three times a day.

Study duration is approximately 30 weeks for each subject including 4 weeks of titration (up to 3 weeks of dose escalation and I week of stabilization for safe escalation to the allocated dose), and 26 weeks of maintenance.

During the titration phase:

The following dose strengths were used to titrate up to the final three strengths that were assigned to the three IPX066 treatment arms.

IPX066 95 mg LD capsule containing 95 mg LD and 23.75 mg CD. IPX066 145 mg LD capsule containing 145 mg LD and 36.25 mg CD. IPX066 195 mg LD capsule containing 195 mg LD and 48.75 mg CD. IPX066 245 mg LD capsule containing 245 mg LD and 61.25 mg CD.

During the maintenance phase:

IPX066 145 mg LD treatment arm received 145 mg LD and 36.25 mg CD. IPX066 245 mg LD treatment arm received 245 mg LD and 61.25 mg CD. IPX066 390 mg LD treatment arm received 390 mg LD and 97.50 mg CD.

Primary efficacy outcome measure was change from baseline in the sum of UPDRS Part II and Part III scores at the end of study or last value reported if subject discontinued prematurely.

Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Diagnosed with idiopathic PD.
3. 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.
4. 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.
5. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
6. Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.

Exclusion Criteria:

1. Pregnant or breastfeeding.
2. Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.
3. Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation.
4. Use of nonselective MAO inhibitors.
5. Use of dopamine agonists within 30 days prior to Screening.
6. Unable to tolerate a placebo regimen, in the Investigator's opinion.
7. Treatment of psychosis with any antipsychotic.
8. History of seizure or epilepsy.
9. Active or prior medical condition or prior surgical procedure that would interfere with LD absorption.
10. History of narrow-angle glaucoma.
11. Subjects with a history of malignant melanoma.
12. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
13. Received any investigational medications during the 30 days prior to Screening.

Primary outcomes:
measure: Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30
timeFrame: Week 30
Secondary outcomes:
measure: Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score
timeFrame: Baseline and Week 30 (or End of Study)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, Dept. of Neurology
state: Alabama
city: Phoenix
country: United States
facility: HOPE Research Institute, LLC
state: Arizona
city: Garden Grove
country: United States
facility: Collaborative NeuroScience Network, Inc.
state: California
city: La Jolla
country: United States
facility: Coastal Neurological Medical Group
state: California
city: La Jolla
country: United States
facility: Coordinated Clinical Research
state: California
city: Sunnyvale
country: United States
facility: The Parkinson's Institute
state: California
city: New Haven
country: United States
facility: Yale Neurology Clinics, Temple Medical Center
state: Connecticut
city: Bradenton
country: United States
facility: Bradenton Research Center, Inc.
state: Florida
city: Hollywood
country: United States
facility: Sunrise Clinical Research, Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Neurological Services
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Neuroscience Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Boise
country: United States
facility: Idaho Elks Rehabilitation Hospital
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center, Dept. of Neurological Sciences
state: Illinois
city: Kansas City
country: United States
facility: Landon Center on Aging, Dept. of Neurology, Parkinson's Disease Center
state: Kansas
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Bingham Farms
country: United States
facility: Quest Research Institute
state: Michigan
city: Golden Valley
country: United States
facility: Struthers Parkinson's Center
state: Minnesota
city: New Brunswick
country: United States
facility: UMDNJ Robert Wood Johnson Medical Center, Department of Neurology
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Syracuse
country: United States
facility: State University of New York Upstate Medical University, Dept. of Neurology
state: New York
city: Durham
country: United States
facility: Duke University Medical Center Movement Disorders Center
state: North Carolina
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine, Parkinson's Disease Center
state: Texas
city: Milwaukee
country: United States
facility: Wisconsin Institute for Neurologic and Sleep Disorders
state: Wisconsin
city: Edmonton
country: Canada
facility: Movement Disorders Clinic, Glenrose Rehabilitation Hospital
state: Alberta
city: Winnipeg
country: Canada
facility: Saint Boniface Clinic
state: Manitoba
city: London
country: Canada
facility: London Health Science Center
state: Ontario
city: Ottawa
country: Canada
facility: Parkinson's and Neurodegenerative Disorders Clinic
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Civic Site
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Sherbrooke
country: Canada
facility: University of Sherbrooke
state: Quebec
city: Quebec
country: Canada
facility: Memory and Motor Skills Clinic
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: West Tallin Central Hopsital
city: Riga
country: Latvia
facility: P.Stradina university hospital
city: Riga
country: Latvia
facility: Gailezers hospital
city: Kaunas
country: Lithuania
facility: Kaunas Medical University Hospital
city: Siauliai
country: Lithuania
facility: Siauliai Regional Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Emergency Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Centre of Gerontology and Rehabilitation
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu klinikos
city: Brasov
country: Romania
facility: Psychiatry and Neurology Hospital, Neurology Department
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital Bucharest, II Neurology Department
city: Cluj Napoca
country: Romania
facility: County Emergency Clinical Hospital Cluj-Napoca, I Neurology Clinic
city: Constanta
country: Romania
facility: CFR Clinical Hospital Constanta
city: Iasi
country: Romania
facility: Clinical Rehabilitation Hospital Iasi, Neurology Department
city: Targu Mures
country: Romania
facility: County Clinical Emergency Hospital, Targu Mures, II Neurology Department,
city: Timisoara
country: Romania
facility: County Clinical Emergency Hospital Timisoara
city: Dnepropetrovsk
country: Ukraine
facility: Neurology department of Regional hospital named after Mechnikov
city: Donetsk
country: Ukraine
facility: Department of Psychiatry and Medical Psychology of Donetsk National Medical University
city: Donetsk
country: Ukraine
facility: Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University
city: Kharkiv
country: Ukraine
facility: 1st neurology department of Central Clinical Hospital of Ukrzaliznytsya
city: Kiev
country: Ukraine
facility: Institute of Gerontology Parkinson's Disease Center
city: Lviv
country: Ukraine
facility: Neurology department of Lviv regional clinical hospital
city: Poltava
country: Ukraine
facility: Neurology department of Medical Dental Academy based on Poltava regional hospital
city: Vinnitsa
country: Ukraine
facility: Neurology department of Vinnitsa Medical University
city: Zaporozhye
country: Ukraine
facility: Neurology department, Zaporozhye State Medical University
Study officials:
affiliation: Impax Laboratories, LLC
name: Impax Study Director
role: STUDY_DIRECTOR
References:
citation: Pahwa R, Lyons KE, Hauser RA, Fahn S, Jankovic J, Pourcher E, Hsu A, O'Connell M, Kell S, Gupta S; APEX-PD Investigators. Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease. Parkinsonism Relat Disord. 2014 Feb;20(2):142-8. doi: 10.1016/j.parkreldis.2013.08.017. Epub 2013 Sep 5.