• PDTrials - Parkinson's Disease Clinical Trials
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Official Study Title: A Phase II, Randomized, Double-Blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. Placebo-Controlled, Dose Response Study of the Efficacy,  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. Safety and Tolerability of Fipamezole as an Oromucosal Fast Dissolving Tablet in the Treatment of Parkinson's Disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. Patients
Sponsor: Juvantia Pharma Ltd./Santhera Pharmaceuticals Ltd.
Clinicaltrials.gov ID: NCT00559871
Study ID: SNT-II-004

Summary

Symptoms of Parkinson's disease (PD) include sudden uncontrollable, often jerky or writhing movements (dyskinesia)  DyskinesiaTwisting, turning or other abnormal involuntary movement usually involving the arms, legs, trunk, and head. It is most commonly associated with long-term use of levodopa. . There is also quite often shortening of the therapeutic effect of levodopa  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. on PD symptoms. The purpose of this study, named FJORD, is specifically to investigate fipamezole's capacity in reducing dyskinetic movements. The safety and efficacy of three dose levels of fipamezole (using a newly developed fast dissolving tablet) will be compared to placebo  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. over a treatment period of 28 days.

The investigators will measure reduction of dyskinetic movements in people with PD as assessed by a dyskinesia assessment scale (LIDS). Further, they will evaluate additional benefits of fipamezole, such as efficacy in extending levodopa anti-parkinsonian action and the impact on cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. functions by neuropsychological testing measurements.

Study Phase

Phase 2/3
What is a study phase?

Symptoms Addressed: Movement and Non-movement

Walking/Gait,  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms. Uncontrollable movements (Dyskinesia), Slowness of movement (bradykinesia)  BradykinesiaSlowness of movement. , Memory

Time Commitment

• Less than six months
• For 9-11 weeks: after the first visit, eight visits at 1-week intervals.

Eligibility

• Minimum Age: 30
• Gender(s) Accepted: Either

Inclusion Criteria

• Diagnosis of PD.
• Levodopa associated dyskinesia which is at least moderately disabling and present for a few hours of the waking day.
• Levodopa-associated end-of-dose deterioration.
• Taking stable Parkinson's medication for at least 1 month prior to study start, with a minimum of 3 hours between the levodopa intakes.
• Demonstrated ability to comprehend and give informed consent.  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial.
• Ability to complete handheld computer diary.

Exclusion Criteria

• Other clinically significant conditions apart from those typically associated with PD.
• Use of St. John's Wort or Ginkgo Biloba within 48 hrs prior to study start and until the last treatment day with the study medication.
• Taking an investigational drug  Investigational DrugDrug that is being tested in clinical trials prior to receiving FDA approval for use on the open market or as a treatment for a particular condition. within 30 days prior to Initial Screening.  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA.
• Taking medication associated with dyskinesia or other physical symptoms, or with induction of liver enzymes; neuroleptics; drugs for cognitive impairment; or other specified drugs (contact study coordinator for more info).

Enrollment

Expected Enrollment: 152 (US)
Date Enrollment Began: Oct 01 2007
Last Updated Date: Feb 22 2008
Trial Post Date: Feb 22 2008
Website: http://www.clinicaltrials.gov/ct2/show/NCT00559871?term=juvantia&rank=1

Primary Contacts and Locations

• Tania Gonzalez
  tania.gonzalez@i3research.com
  Phone: 931-553-0132
  

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