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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Juvantia Pharma Ltd
• Collaborator: Santhera Pharmaceuticals

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.