Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease

NCT01789047 | Terminated Phase 2 Results DMC

• 1 other identifier: TOP-DYSK
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 5

Brief Summary

The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed comparison between add-on topiramate and add-on placebo to stable treatment with amatadine in the treatment of Parkinson's disease (PD) patients who continue to have dyskinesia on amantadine.

Conditions

Idiopathic Parkinson's Disease; Drug Induced Dyskinesia

Keywords

Parkinson's disease; dyskinesia; Indonesia; amantadine

Outcome Measures

Primary Outcomes (1)

• The Unified Dyskinesia Rating Scale (UDysRS)

  The Unified Dyskinesia Rating Scale (UDysRS) will be the primary outcome measure for this study. This choice is based on the outcome of the Validation of Dyskinesia Rating Scales study. In this study, the UDysRS was identified as the most sensitive scale to detect change in dyskinesia in an 8-week, double-blind, placebo-controlled trial of amatadine. The UDysRS utilizes rater information, patient self-report and objective measures of dyskinesia to provide assessments of impairment and disability due to dyskinesia. Score ranges are 0-108 with higher scores representing more severe impairment.

  Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale

Other Outcomes (3)

• Clinical Global Impression - Change Score

  Assessed at Week 10 and 14 by blinded treating physician and subject

• Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  Assessed at baseline, week 6, week 10 and week 14

• Hoehn & Yahr Staging

  Assessment completed at baseline, week 6, week 10 and week 14

Study Arms (2)

Topiramate

ACTIVE COMPARATOR

Topiramate as adjunct to amantadine.

Drug: Topiramate; Drug: Amantadine

Placebo (sugar pill)

PLACEBO COMPARATOR

Placebo

Drug: Placebo; Drug: Amantadine

Interventions

Topiramate DRUG

Topiramate as adjunct to amantadine

Also known as: Topamax

Topiramate

Placebo DRUG

Placebo control

Also known as: sugar pill

Placebo (sugar pill)

Amantadine DRUG

Existing treatment for all participants

Also known as: Symmetrel

Placebo (sugar pill); Topiramate

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's disease patient, defined by United Kingdom (UK) Brain Bank criteria
• Current age between 30-90
• Clinically pertinent dyskinesias defined by Clinical Global Impression - Severity (CGI-s) score (see attachment) \> 3 (mild) established by clinician's total assessment of patient including objective observation during the screening process. \*
• Stable doses of all antiparkinsonian medications for at least 4 weeks
• Stable treatment with at least 200 mg amantadine for at least 4 weeks.
• Presence of a caregiver willing to participate in the study
• 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.
• Subjects must be free of dementia, depression and psychosis as determined by clinical examination.
• The subject must be willing to participate in all study related activities and visits.

You may not qualify if:

• Any subjects with clinical evidence suggestive of an atypical or secondary form of Parkinson's Disease
• Any subject who, in the opinion of the Principal Investigator, has a concomitant medical illness which would preclude them from being treated with amantadine,
• Any subject who, in the opinion of the Principal Investigator, will be unable to maintain current stable dosing of their anti-parkinsonian medications for the duration of the trial,
• Any subject with evidence for dementia, depression, or psychosis, as determined by clinical examination.
• Any subject who has not signed informed consent, or unable or unwilling to participate in all of the study related activities.

Sponsors & Collaborators

• Rush University Medical Center: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (5)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Dyskinesia, Drug-Induced; Dyskinesias

Interventions

Topiramate; Sugars; Amantadine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Neurotoxicity Syndromes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Carbohydrates; Ketoses; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Rush University Medical Center

Teresa_Chmura@rush.edu

312 942 8002

Study Officials

• Christopher G Goetz, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 11, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-03

Locations

US (5)