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

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ClinicalTrials.gov Identifier: NCT00559871
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : June 3, 2009
Sponsor:
Collaborator:
Santhera Pharmaceuticals
Information provided by:
Juvantia Pharma Ltd

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: fipamezole Phase 2

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  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: JP-1730




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559871


  Show 36 Study Locations
Sponsors and Collaborators
Juvantia Pharma Ltd
Santhera Pharmaceuticals
Investigators
Principal Investigator: Peter A. LeWitt, M.D. Henry Ford Health Systems, Franklin Pointe Medical Center

Responsible Party: Juha M. Savola, Director Clinical Development, Santhera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00559871     History of Changes
Other Study ID Numbers: SNT-II-004
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: June 2009

Keywords provided by Juvantia Pharma Ltd:
dyskinesia
movement disorders
basal ganglia diseases
JP-1730
Parkinson
end-of-dose wearing off
fluctuations

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases