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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fipamezole
Sponsored by
Juvantia Pharma Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring dyskinesia, movement disorders, basal ganglia diseases, JP-1730, Parkinson, end-of-dose wearing off, fluctuations

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Neurology Clinic PC
  • University of Arizona Health Sciences Center
  • Parkinson and Movement Disorder Institute
  • University of California Irvine
  • Coastal Neurological Medicine Group
  • Colorado Neurological Institute
  • Parkinson's Disease and Movement Disorder Center
  • Sunrise Clinical Research
  • Pharmax Research Clinic
  • University of Miami
  • Collier Neurological Clinic
  • University of South Florida, Parkinson's Disease and Movement Center
  • Emory Healthcare
  • Medical College of Georgia
  • Rush University Medical Center
  • Parkinson Disease Center - University of Kansas Medical Center
  • Ochsner Clinic Foundation
  • Maryland Parkinson's Disease and Movement Disorder Center
  • U Mass Memorial Medical Center
  • Henry Ford Health Systems, Franklin Pointe Medical Center
  • Struthers Parkinson's Center
  • Neurology Group of Bergen County
  • Biomedical Research Alliance of New York
  • Duke Health Center at Morreene Road
  • Oregon Health and Science University
  • Semmes Murphey Neurologic and Spine Institute
  • Baylor College of Medicine
  • Neurology Associates
  • Max Superspecialty Hospital
  • Neurology centre
  • St John's Medical College & Hospital
  • M S Ramaiah Medical College Hospital
  • Nizam's Institute of Medical Sciences
  • Chatrapati Sahuji Maharaj Medical University
  • J.S.S. Medical College and Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

One placebo tablet administered tid from Day 1 to 28

One 30-mg tablet of Fipamezole tid from Day 1 to 28

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

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

Outcomes

Primary Outcome Measures

To compare the efficacy of 3 different doses of fipamezole with that of placebo on dyskinesia as assessed by a dyskinesia assessment scale.

Secondary Outcome Measures

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.

Full Information

First Posted
November 15, 2007
Last Updated
June 2, 2009
Sponsor
Juvantia Pharma Ltd
Collaborators
Santhera Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00559871
Brief Title
Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Juvantia Pharma Ltd
Collaborators
Santhera Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
dyskinesia, movement disorders, basal ganglia diseases, JP-1730, Parkinson, end-of-dose wearing off, fluctuations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
One placebo tablet administered tid from Day 1 to 28
Arm Title
2
Arm Type
Active Comparator
Arm Description
One 30-mg tablet of Fipamezole tid from Day 1 to 28
Arm Title
3
Arm Type
Active Comparator
Arm Description
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
Arm Title
4
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
fipamezole
Other Intervention Name(s)
JP-1730
Intervention Description
Fipamezole in Zydis formulation three times per day for up to 28 days
Primary Outcome Measure Information:
Title
To compare the efficacy of 3 different doses of fipamezole with that of placebo on dyskinesia as assessed by a dyskinesia assessment scale.
Time Frame
28-days treatment
Secondary Outcome Measure Information:
Title
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.
Time Frame
28-days treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A. LeWitt, M.D.
Organizational Affiliation
Henry Ford Health Systems, Franklin Pointe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Neurology Clinic PC
City
Northport
State/Province
Alabama
ZIP/Postal Code
35476
Country
United States
Facility Name
University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5023
Country
United States
Facility Name
Parkinson and Movement Disorder Institute
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Coastal Neurological Medicine Group
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Parkinson's Disease and Movement Disorder Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Sunrise Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Pharmax Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Collier Neurological Clinic
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
University of South Florida, Parkinson's Disease and Movement Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Parkinson Disease Center - University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Maryland Parkinson's Disease and Movement Disorder Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
U Mass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655-0318
Country
United States
Facility Name
Henry Ford Health Systems, Franklin Pointe Medical Center
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Struthers Parkinson's Center
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
Facility Name
Neurology Group of Bergen County
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Biomedical Research Alliance of New York
City
Forest Hills
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Facility Name
Duke Health Center at Morreene Road
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Semmes Murphey Neurologic and Spine Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Neurology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Max Superspecialty Hospital
City
Saket
State/Province
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Neurology centre
City
Ahmedabad
ZIP/Postal Code
380006
Country
India
Facility Name
St John's Medical College & Hospital
City
Bangalore
ZIP/Postal Code
560 034
Country
India
Facility Name
M S Ramaiah Medical College Hospital
City
Bangalore
ZIP/Postal Code
560 054
Country
India
Facility Name
Nizam's Institute of Medical Sciences
City
Hyderabaad
ZIP/Postal Code
500 082
Country
India
Facility Name
Chatrapati Sahuji Maharaj Medical University
City
Lucknow
ZIP/Postal Code
226003
Country
India
Facility Name
J.S.S. Medical College and Hospital
City
Mysore
ZIP/Postal Code
570 004
Country
India

12. IPD Sharing Statement

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

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