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

This study has been completed.
Sponsor:
Collaborator:
Santhera Pharmaceuticals
Information provided by:
Juvantia Pharma Ltd
ClinicalTrials.gov Identifier:
NCT00559871
First received: November 15, 2007
Last updated: June 2, 2009
Last verified: June 2009

November 15, 2007
June 2, 2009
October 2007
May 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00559871 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
Drug: fipamezole
Fipamezole in Zydis formulation three times per day for up to 28 days
Other Name: JP-1730
  • Placebo Comparator: 1
    One placebo tablet administered tid from Day 1 to 28
    Intervention: Drug: fipamezole
  • Active Comparator: 2
    One 30-mg tablet of Fipamezole tid from Day 1 to 28
    Intervention: Drug: fipamezole
  • 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
    Intervention: Drug: fipamezole
  • 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
    Intervention: Drug: fipamezole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   India
 
NCT00559871
SNT-II-004
Yes
Juha M. Savola, Director Clinical Development, Santhera Pharmaceuticals
Juvantia Pharma Ltd
Santhera Pharmaceuticals
Principal Investigator: Peter A. LeWitt, M.D. Henry Ford Health Systems, Franklin Pointe Medical Center
Juvantia Pharma Ltd
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP