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.

The purpose of this study is to determine whether Fipamezole is effective in the treatment of levodopa-induced dyskinesia in advanced Parkinson's disease.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: fipamezole

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Ahmedabad, India, 380006
    • Neurology Centre
  • Bangalore, India, 560 034
    • St John's Medical College & Hospital
  • Bangalore, India, 560 054
    • M S Ramaiah Medical College Hospital
  • Hyderabaad, India, 500 082
    • Nizam's Institute of Medical Sciences
  • Lucknow, India, 226003
    • Chatrapati Sahuji Maharaj Medical University
  • Mysore, India, 570 004
    • J.S.S. Medical College and Hospital
  • New Delhi
    • Saket, New Delhi, India, 110017
      • Max Superspecialty Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Northport, Alabama, United States, 35476
      • Neurology Clinic PC
  • Arizona
    • Tucson, Arizona, United States, 85724-5023
      • University of Arizona Health Sciences Center
  • California
    • Fountain Valley, California, United States, 92708
      • Parkinson and Movement Disorder Institute
    • Irvine, California, United States, 92697
      • University of California Irvine
    • La Jolla, California, United States, 92037
      • Coastal Neurological Medicine Group
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Colorado Neurological Institute
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorder Center
    • Hollywood, Florida, United States, 33021
      • Sunrise Clinical Research
    • Miami, Florida, United States, 33136
      • University of Miami
    • Miami, Florida, United States, 33126
      • Pharmax Research Clinic
    • Naples, Florida, United States, 34102
      • Collier Neurological Clinic
    • Tampa, Florida, United States, 33606
      • University of South Florida, Parkinson's Disease and Movement Center
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory Healthcare
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Parkinson Disease Center - University of Kansas Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Maryland Parkinson's Disease and Movement Disorder Center
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655-0318
      • U Mass Memorial Medical Center
  • Michigan
    • Southfield, Michigan, United States, 48034
      • Henry Ford Health Systems, Franklin Pointe Medical Center
  • Minnesota
    • Golden Valley, Minnesota, United States, 55427
      • Struthers Parkinson's Center
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • Neurology Group of Bergen County
  • New York
    • Forest Hills, New York, United States, 11375
      • Biomedical Research Alliance Of New York
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Health Center at Morreene Road
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • Oregon Health and Science University
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Semmes Murphey Neurologic and Spine Institute
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • San Antonio, Texas, United States, 78258
      • Neurology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; One placebo tablet administered tid from Day 1 to 28	Drug: fipamezole; Fipamezole in Zydis formulation three times per day for up to 28 days; Other Names: JP-1730
Active Comparator: 2; One 30-mg tablet of Fipamezole tid from Day 1 to 28	Drug: fipamezole; Fipamezole in Zydis formulation three times per day for up to 28 days; Other Names: JP-1730
Active Comparator: 3; 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	Drug: fipamezole; Fipamezole in Zydis formulation three times per day for up to 28 days; Other Names: JP-1730
Active Comparator: 4; 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	Drug: fipamezole; Fipamezole in Zydis formulation three times per day for up to 28 days; Other Names: JP-1730

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Juvantia Pharma Ltd
• Collaborators: Santhera Pharmaceuticals
• Investigators: Principal Investigator: Peter A. LeWitt, M.D., Henry Ford Health Systems, Franklin Pointe Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: November 15, 2007
• First Submitted That Met QC Criteria: November 15, 2007
• First Posted (Estimate): November 16, 2007

Study Record Updates

• Last Update Posted (Estimate): June 3, 2009
• Last Update Submitted That Met QC Criteria: June 2, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Parkinson; dyskinesia; movement disorders; basal ganglia diseases; JP-1730; end-of-dose wearing off; fluctuations
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: SNT-II-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No