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Official Study Title: Validation of 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. Rating Scales
Sponsor: The Michael J. Fox Foundation for Parkinson's Research
Clinicaltrials.gov ID: NCT01071395
Study ID:

Summary

Dyskinesias, or involuntary jerking movements, are troublesome problems for many people with Parkinson’s disease (PD).   Chemical studies have led to the development of several new treatment strategies.  However, because dyskinesias cause various degrees of difficulty for people with PD and are often perceived by people with PD and caregivers differently than by doctors, the rating of dyskinesias remains a scientific challenge.  This study will examine a wide gamut of available rating scales to determine which one(s) detect change during dyskinesia treatment.  Establishing excellent measurement tools of dyskinesias will allow future treatments to be evaluated in a maximally effective manner.

This study will evaluate the responsiveness of a variety of available dyskinesia rating scales to treatment with amantadine or 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. in people with Parkinson’s disease who have dyskinesia.The study will be a 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. (both participants and researchers do not know who will receive the placebo), randomized trial  Randomized TrialStudy in which participants re randomly assigned between experimental treatment and control arms; the “gold standard” in clinical trials, to minimize differences between the groups being compared and safeguard against bias. Occasionally placebos are used. of 60 participants administered with amantadine or placebo for 8 weeks.  Pre-treatment evaluations will be performed and compared to end of study evaluations on the best daily dose.  

The goal of this study is to provide researchers with the best scale(s) to distinguish dyskinesia change in PD associated with amantadine and to establish the greatest effect achievable with amantadine. Amantadine is selected for this trial, because it is the only drug that has received the designation of Efficacious for dyskinesia by the Movement Disorder Society.  This conclusion was based however, on small studies and no large clinical trial  Clinical Trial (Clinical Study)A scientific study involving human participants to determine the safety and efficacy of new therapies or new ways of using known treatments. of this drug has been conducted in dyskinetic people. This study will establish a “gold standard” for rating dyskinesia in future trials of treatments in people with PD.  It will allow physicians to know the level of change that occurs with a standard and available treatment (amantadine) and to compare that level with changes that occur with newer treatments.  People with PD will benefit from this new international standard, because they can compare the likelihood and magnitude of anticipated improvement from different dyskinesia treatments, whether medical or surgical.

Additionally, with the use of paper and pencil questionnaires, the study will investigate the impact of participant optimism and participant and rater expectation of positive effects on the dyskinesia rating outcomes.

Study Phase

Phase 4
What is a study phase?

Symptoms Addressed: Movement Symptoms

Uncontrollable movements (Dyskinesia)

Time Commitment

• Less than six months
• The study will last for 8 weeks. Participants will be asked to attend four in-person study visits (Screening,  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. Baseline,  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. Week 4 and Week 8). In addition, two telephone visits will be done at Week 2 and week 3 to assess safety issues and tolerability.

Eligibility

• Minimum Age: 30
• Maximum Age: 80
• Gender(s) Accepted: Either

Inclusion Criteria

• Diagnosis of Parkinson’s disease
• Current age between 30-90
• Clinically pertinent dyskinesias established by clinician’s objective assessment during the screening process.
• Creatine level at screening evaluation that is within the normal range.
• Stable doses of antiparkinsonian medications for at least 4 weeks
• No treatment with amantadine for at least 3 months.
• Presence of a caregiver willing to participate in the study
• Participants/caregivers must demonstrate the capacity to complete an accurate home diary based on training and evaluation during the screening period
• Participants must be able to provide written 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.
• If the participant received amantadine in the past, the drug was stopped for reason other than adverse events.  
• In the opinion of the enrolling investigator, the participant will be able to maintain current dosing schedule of antiparkinsonian drugs for the duration of the trial.
• The participant must be willing to participate in all study related activities and visits.

Exclusion Criteria

• People who have had prior brain surgery.
• People with other major illnesses that could be complicated by amantadine exposure, including glaucoma, current hallucinations, urinary retention.
• People with dementia,  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality. depression and psychosis  PsychosisA loss of contact with reality often accompanied by hallucinations. Psychosis can be caused by some PD medications and is more common in patients with advanced Parkinson's. as determined by clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. examination.

Enrollment

Expected Enrollment: 60 (US)
Date Enrollment Began: Jan 2010
Date Enrollment Ends: Dec 2010
Last Updated Date: Mar 10 2010
Trial Post Date: Mar 10 2010
Website: http://www.clinicaltrials.gov/ct2/show/NCT01071395

Primary Contacts and Locations

Illinois

• Glenn T. Stebbins, Ph.D.
  Rush University Medical Center
  gtstebbin@rush.edu
  Phone: (312) 563-3854
  1725 West Harrison Street
  Suite #755
  Chicago, IL 60612
  USA
  
• Christopher G. Goetz, M.D.
  Rush University Medical Center
  cgoetz@rush.edu
  Phone: (312) 942-8016
  1725 West Harrison Street
  Suite #755
  Chicago, IL 60612
  USA
  
• Luci Blasucci, R.N.
  Rush University Medical Center
  lucia_m_blasucci@rush.edu
  Phone: (312) 563-2900, Ext. #4
  1725 West Harrison Street
  Suite #755
  Chicago, IL 60612
  USA
  

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