Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease
- Registration Number
- NCT00559871
- Lead Sponsor
- Juvantia Pharma Ltd
- Brief Summary
The purpose of this study is to determine whether Fipamezole is effective in the treatment of levodopa-induced dyskinesia in advanced Parkinson's disease.
- Detailed Description
This study is a multi-center, double-blind, placebo-controlled, multiple dose escalating, safety, tolerance, pharmacokinetics, and efficacy study of fipamezole administered in Parkinson's disease patients who are concomitantly being treated with a combination product of levodopa with a dopamine decarboxylase inhibitor (DDI) and possible other antiparkinson medication. Approximately 30 sites in the US and India will participate in this study. The patients will be randomized into one of four treatment arms to receive either fixed or ascending doses of Fipamezole (from 30 to 90 mg tid) or placebo. For efficacy assessments, levodopa-induced dyskinesia is assessed using a standardised rating scale. Time spent in 'Off' state or in 'On' state without dyskinesia, 'On' with non-troublesome dyskinesia or 'On' with troublesome dyskinesia, is assessed using patient diaries. Impact of dyskinesia on daily activities is quantified using a PDYS-26 questionnaire. To explore potential positive or negative impact of Fipamezole on cognitive functions, the study includes two cognitive tests. Finally, the study includes investigator assessments of CGI-I scales for dyskinesia, Parkinson's disease, and clinical condition in general.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- Idiopathic Parkinson's disease.
- Levodopa/DDI associated peak-dose dyskinesia which is at least moderately disabling and present for ≥25% of the waking day (UPDRS part IV, items 32 and 33, each ≥ 2).
- Stable Parkinson's medication for at least 1 month prior to randomization.
- Hoehn and Yahr Stages 1 to 4 during 'Off' period.
- Demonstrated ability to comprehend and give informed consent.
- Ability to complete patient diary.
Main
- Other clinically significant conditions apart from those typically associated with Parkinson's disease.
- Intake of medication associated with exacerbation of dyskinesia or with extrapyramidal side effects and tardive dyskinesia or induction of liver enzymes; neuroleptics; or specified drugs known to be substantially metabolized through the following cytochrome P450 isoenzymes: 1A2, 2B6, 2C19, 2C9, 2D6, and 2E1.
- Use of St. John's Wort or Ginkgo Biloba within 48 hrs prior to randomization and until the last treatment day with the study medication.
- Intake of an investigational drug within 30 days prior to initial screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 fipamezole One 30-mg tablet of Fipamezole tid from Day 1 to 28 3 fipamezole One 30-mg tablet of Fipamezole tid from Day 1 to 7; and one 60-mg tablet of Fipamezole tid from Day 8 to 28 1 fipamezole One placebo tablet administered tid from Day 1 to 28 4 fipamezole One 30-mg tablet of Fipamezole tid from Day 1 to 7; one 60-mg tablet of Fipamezole tid from Day 8 to 14; and one 90-mg tablet of Fipamezole tid from Day 15 to 28
- Primary Outcome Measures
Name Time Method To compare the efficacy of 3 different doses of fipamezole with that of placebo on dyskinesia as assessed by a dyskinesia assessment scale. 28-days treatment
- Secondary Outcome Measures
Name Time Method To compare efficacy of 3 different doses of fipamezole with that of placebo on the mean daily 'Off' time, as recorded in the patient diary. 28-days treatment
Trial Locations
- Locations (36)
Colorado Neurological Institute
🇺🇸Englewood, Colorado, United States
Neurology Group of Bergen County
🇺🇸Ridgewood, New Jersey, United States
Maryland Parkinson's Disease and Movement Disorder Center
🇺🇸Baltimore, Maryland, United States
Nizam's Institute of Medical Sciences
🇮🇳Hyderabaad, India
Chatrapati Sahuji Maharaj Medical University
🇮🇳Lucknow, India
Semmes Murphey Neurologic and Spine Institute
🇺🇸Memphis, Tennessee, United States
Max Superspecialty Hospital
🇮🇳Saket, New Delhi, India
M S Ramaiah Medical College Hospital
🇮🇳Bangalore, India
Neurology centre
🇮🇳Ahmedabad, India
Parkinson Disease Center - University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Struthers Parkinson's Center
🇺🇸Golden Valley, Minnesota, United States
Neurology Clinic PC
🇺🇸Northport, Alabama, United States
Parkinson and Movement Disorder Institute
🇺🇸Fountain Valley, California, United States
University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
University of California Irvine
🇺🇸Irvine, California, United States
Coastal Neurological Medicine Group
🇺🇸La Jolla, California, United States
Emory Healthcare
🇺🇸Atlanta, Georgia, United States
Parkinson's Disease and Movement Disorder Center
🇺🇸Boca Raton, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Collier Neurological Clinic
🇺🇸Naples, Florida, United States
Sunrise Clinical Research
🇺🇸Hollywood, Florida, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Biomedical Research Alliance of New York
🇺🇸Forest Hills, New York, United States
St John's Medical College & Hospital
🇮🇳Bangalore, India
U Mass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Henry Ford Health Systems, Franklin Pointe Medical Center
🇺🇸Southfield, Michigan, United States
J.S.S. Medical College and Hospital
🇮🇳Mysore, India
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Pharmax Research Clinic
🇺🇸Miami, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
University of South Florida, Parkinson's Disease and Movement Center
🇺🇸Tampa, Florida, United States
Duke Health Center at Morreene Road
🇺🇸Durham, North Carolina, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Neurology Associates
🇺🇸San Antonio, Texas, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States