Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease
Fjord
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose Response Study of the Efficacy, Safety and Tolerability of Fipamezole as an Oromucosal Fast Dissolving Tablet in the Treatment of Parkinson's Disease Patients.
1 other identifier
interventional
180
2 countries
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2007
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 15, 2007
CompletedFirst Posted
Study publicly available on registry
November 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedJune 3, 2009
June 1, 2009
1.6 years
November 15, 2007
June 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (4)
1
PLACEBO COMPARATOROne placebo tablet administered tid from Day 1 to 28
2
ACTIVE COMPARATOROne 30-mg tablet of Fipamezole tid from Day 1 to 28
3
ACTIVE COMPARATOROne 30-mg tablet of Fipamezole tid from Day 1 to 7; and one 60-mg tablet of Fipamezole tid from Day 8 to 28
4
ACTIVE COMPARATOROne 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
Interventions
Fipamezole in Zydis formulation three times per day for up to 28 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Juvantia Pharma Ltdlead
- Santhera Pharmaceuticalscollaborator
Study Sites (36)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Neurology Clinic PC
Northport, Alabama, 35476, United States
University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5023, United States
Parkinson and Movement Disorder Institute
Fountain Valley, California, 92708, United States
University of California Irvine
Irvine, California, 92697, United States
Coastal Neurological Medicine Group
La Jolla, California, 92037, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
Parkinson's Disease and Movement Disorder Center
Boca Raton, Florida, 33486, United States
Sunrise Clinical Research
Hollywood, Florida, 33021, United States
Pharmax Research Clinic
Miami, Florida, 33126, United States
University of Miami
Miami, Florida, 33136, United States
Collier Neurological Clinic
Naples, Florida, 34102, United States
University of South Florida, Parkinson's Disease and Movement Center
Tampa, Florida, 33606, United States
Emory Healthcare
Atlanta, Georgia, 30329, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Parkinson Disease Center - University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Maryland Parkinson's Disease and Movement Disorder Center
Baltimore, Maryland, 21201, United States
U Mass Memorial Medical Center
Worcester, Massachusetts, 01655-0318, United States
Henry Ford Health Systems, Franklin Pointe Medical Center
Southfield, Michigan, 48034, United States
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427, United States
Neurology Group of Bergen County
Ridgewood, New Jersey, 07450, United States
Biomedical Research Alliance of New York
Forest Hills, New York, 11375, United States
Duke Health Center at Morreene Road
Durham, North Carolina, 27705, United States
Oregon Health and Science University
Portland, Oregon, 97239-3098, United States
Semmes Murphey Neurologic and Spine Institute
Memphis, Tennessee, 38104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Neurology Associates
San Antonio, Texas, 78258, United States
Max Superspecialty Hospital
Saket, New Delhi, 110017, India
Neurology centre
Ahmedabad, 380006, India
St John's Medical College & Hospital
Bangalore, 560 034, India
M S Ramaiah Medical College Hospital
Bangalore, 560 054, India
Nizam's Institute of Medical Sciences
Hyderabaad, 500 082, India
Chatrapati Sahuji Maharaj Medical University
Lucknow, 226003, India
J.S.S. Medical College and Hospital
Mysore, 570 004, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter A. LeWitt, M.D.
Henry Ford Health Systems, Franklin Pointe Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 15, 2007
First Posted
November 16, 2007
Study Start
October 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
June 3, 2009
Record last verified: 2009-06