Clinical trial NCT00559871: Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: dyskinesia
movement disorders
basal ganglia diseases
JP-1730
Parkinson
end-of-dose wearing off
fluctuations
Lead sponsor: Juvantia Pharma Ltd
Sponsor class: INDUSTRY
Collaborators: name: Santhera Pharmaceuticals
First posted: 2007-11-16
Enrollment: 180
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: 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.

Eligibility criteria: Main Inclusion Criteria:

* 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 Exclusion Criteria:

* 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.

Primary outcomes:
measure: To compare the efficacy of 3 different doses of fipamezole with that of placebo on dyskinesia as assessed by a dyskinesia assessment scale.
timeFrame: 28-days treatment
Secondary outcomes:
measure: 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.
timeFrame: 28-days treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Northport
country: United States
facility: Neurology Clinic PC
state: Alabama
city: Tucson
country: United States
facility: University of Arizona Health Sciences Center
state: Arizona
city: Fountain Valley
country: United States
facility: Parkinson and Movement Disorder Institute
state: California
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: La Jolla
country: United States
facility: Coastal Neurological Medicine Group
state: California
city: Englewood
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorder Center
state: Florida
city: Hollywood
country: United States
facility: Sunrise Clinical Research
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Naples
country: United States
facility: Collier Neurological Clinic
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Parkinson's Disease and Movement Center
state: Florida
city: Atlanta
country: United States
facility: Emory Healthcare
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: Parkinson Disease Center - University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Maryland Parkinson's Disease and Movement Disorder Center
state: Maryland
city: Worcester
country: United States
facility: U Mass Memorial Medical Center
state: Massachusetts
city: Southfield
country: United States
facility: Henry Ford Health Systems, Franklin Pointe Medical Center
state: Michigan
city: Golden Valley
country: United States
facility: Struthers Parkinson's Center
state: Minnesota
city: Ridgewood
country: United States
facility: Neurology Group of Bergen County
state: New Jersey
city: Forest Hills
country: United States
facility: Biomedical Research Alliance of New York
state: New York
city: Durham
country: United States
facility: Duke Health Center at Morreene Road
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Memphis
country: United States
facility: Semmes Murphey Neurologic and Spine Institute
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Neurology Associates
state: Texas
city: Saket
country: India
facility: Max Superspecialty Hospital
state: New Delhi
city: Ahmedabad
country: India
facility: Neurology centre
city: Bangalore
country: India
facility: St John's Medical College & Hospital
city: Bangalore
country: India
facility: M S Ramaiah Medical College Hospital
city: Hyderabaad
country: India
facility: Nizam's Institute of Medical Sciences
city: Lucknow
country: India
facility: Chatrapati Sahuji Maharaj Medical University
city: Mysore
country: India
facility: J.S.S. Medical College and Hospital
Study officials:
affiliation: Henry Ford Health Systems, Franklin Pointe Medical Center
name: Peter A. LeWitt, M.D.
role: PRINCIPAL_INVESTIGATOR
References: