Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
68 participants
INTERVENTIONAL
2010-01-31
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The responsiveness of the different scales will be evaluated statistically with a mixed model in which changes in the outcome measures over time will include a fixed effect of treatment group assignment. The model will additionally account for random effects of intercepts (the scale scores at baseline) that will include both random variation (person-specific) and specific variation associated with rate of change in outcome. The investigators may include adjustments for possible confounding covariates, including baseline demographics and center. The goal of the program is to provide researchers with the best scale(s) to distinguish dyskinesia change in Parkinson's disease (PD) associated with amantadine in comparison to placebo and to establish the magnitude of effect achievable with amantadine as a comparator "gold standard" that must be met or surpassed by future anti-dyskinetic agents. Additionally, with the use of paper and pencil questionnaires, the study will investigate the impact of patient optimism and patient and rater expectation of positive effects on the dyskinesia rating outcomes.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Dyskinesias, or involuntary jerking movements, are troublesome problems for many Parkinson's disease patients. Chemical studies have led to the development of several new treatment strategies. However, because dyskinesias are cause various degrees of difficulty for patients and are often perceived by patients and caregivers differently than by doctors, the rating of dyskinesias remains a scientific challenge. This program 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 uniform and maximally effective manner.
Project Description:
An team of experts will test several dyskinesia scales in a group of Parkinson's disease patients with dyskinesia. Patients will be treated with either amantadine or placebo (an inactive product). The study will be "blinded" so that the raters and the patients do not know if a given patient is receiving amantadine or placebo. 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 of this drug has been conducted in dyskinetic patients. The scales will assess dyskinesia before and after several weeks of treatment.
Relevance to Diagnosis/Treatment of Parkinson's Disease:
This study will establish a "gold standard" for rating dyskinesia in future trials of treatments in Parkinson's disease patients. 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. Patients 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.
Anticipated Outcome:
The anticipated outcomes of this study are:
* The impact of amantadine treatment on dyskinesia will be clearly defined.
* The effect that participation in a clinical program, even if no amantadine is given ("placebo improvements") will be delineated.
* A hierarchy of numerous scales will be determined based on their absolute and relative capability to detect change during treatment.
* The best scale(s) to evaluate dyskinesia in clinical practice and research efforts will be identified.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Amantadine
Amantadine 100mg tab BID or TID for duration of study
Amantadine
Amantadine hydrochloride 300mg daily in three divided doses
Placebo
Placebo one tab BID or TID for duration of study
Placebo
Sugar pill given 3 times daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Amantadine
Amantadine hydrochloride 300mg daily in three divided doses
Placebo
Sugar pill given 3 times daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Current age between 30-90
3. Clinically pertinent dyskinesias defined by Clinical Gl;obal Impression-severity score (see attachment) \> 3 (mild) established by clinician's total assessment of patient including objective observation during the screening process. \*
4. Documentation of creatinine level at screening evaluation that is within the normal range for the local university laboratory.
5. Stable doses of all antiparkinsonian medications for at least 4 weeks
6. No treatment with amantadine for at least 3 months.
7. Presence of a caregiver willing to participate in the study
8. Subjects/caregivers must demonstrate the capacity to complete an accurate home diary based on training and evaluation during the screening period (see attached training rules).
9. Subjects must be able to provide written informed consent.
10. If the subject received amantadine in the past, the drug was stopped for reason other than adverse events.
11. In the opinion of the enrolling investigator, the subject will be able to maintain current dosing schedule of antiparkinsonian drugs for the duration of the trial.
12. The subject must be willing to participate in all study related activities and visits.
Exclusion Criteria
2. Subjects with other major illnesses that could be complicated by amantadine exposure, including glaucoma, current hallucinations, urinary retention.
3. Subjects with dementia, depression and psychosis as determined by clinical examination.
30 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Michael J. Fox Foundation for Parkinson's Research
OTHER
Rush University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Christopher G. Goetz, MD
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christopher G Goetz, MD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Glenn T Stebbins, PhD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama-Birmingham (UAB)
Birmingham, Alabama, United States
University of South Florida
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Duke University
Durham, North Carolina, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
Universitatsklinik fur Neurologie
Innsbruck, , Austria
Toronto Western Hospital (Movement Disorder Center)
Toronto, Ontario, Canada
Centre d'investigation Clinique, CHU de Toulouse
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Parkinson's Disease Foundation
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Valid Dyskin Rating Scales
Identifier Type: -
Identifier Source: org_study_id