Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease

Parkinson's Disease Clinical Trial

— Fjord  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559871
• Other study ID #: SNT-II-004
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2007
• Last updated: June 2, 2009
• Start date: October 2007
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Juvantia Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• fipamezole
Fipamezole in Zydis formulation three times per day for up to 28 days

Locations

Country	Name	City	State
India	Neurology centre	Ahmedabad
India	M S Ramaiah Medical College Hospital	Bangalore
India	St John's Medical College & Hospital	Bangalore
India	Nizam's Institute of Medical Sciences	Hyderabaad
India	Chatrapati Sahuji Maharaj Medical University	Lucknow
India	J.S.S. Medical College and Hospital	Mysore
India	Max Superspecialty Hospital	Saket	New Delhi
United States	Emory Healthcare	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	Maryland Parkinson's Disease and Movement Disorder Center	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Parkinson's Disease and Movement Disorder Center	Boca Raton	Florida
United States	Rush University Medical Center	Chicago	Illinois
United States	Duke Health Center at Morreene Road	Durham	North Carolina
United States	Colorado Neurological Institute	Englewood	Colorado
United States	Biomedical Research Alliance of New York	Forest Hills	New York
United States	Parkinson and Movement Disorder Institute	Fountain Valley	California
United States	Struthers Parkinson's Center	Golden Valley	Minnesota
United States	Sunrise Clinical Research	Hollywood	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	University of California Irvine	Irvine	California
United States	Parkinson Disease Center - University of Kansas Medical Center	Kansas City	Kansas
United States	Coastal Neurological Medicine Group	La Jolla	California
United States	Semmes Murphey Neurologic and Spine Institute	Memphis	Tennessee
United States	Pharmax Research Clinic	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Collier Neurological Clinic	Naples	Florida
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Neurology Clinic PC	Northport	Alabama
United States	Oregon Health and Science University	Portland	Oregon
United States	Neurology Group of Bergen County	Ridgewood	New Jersey
United States	Neurology Associates	San Antonio	Texas
United States	Henry Ford Health Systems, Franklin Pointe Medical Center	Southfield	Michigan
United States	University of South Florida, Parkinson's Disease and Movement Center	Tampa	Florida
United States	University of Arizona Health Sciences Center	Tucson	Arizona
United States	U Mass Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Juvantia Pharma Ltd	Santhera Pharmaceuticals

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No