NCT00296959

Brief Summary

A phase II double blind trial to evaluate the effects of the AMPA, glutamte antagonist, topiramate on levodopa-induced dyskinesia in Parkinson's disease

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

September 20, 2007

Status Verified

August 1, 2007

First QC Date

February 23, 2006

Last Update Submit

September 19, 2007

Conditions

Parkinson's Disease

Keywords

DyskinesiaAMPA receptor antagonists

Outcome Measures

Primary Outcomes (1)

  • investigator-rated change in dyskinesia severity from video recordings using Goetz Dyskinesia scale

Secondary Outcomes (6)

  • subject-rated change in dyskinesia severity

  • subject-rated change in dyskinesia disability

  • subject-rated parkinsonian disability

  • investigator-rated parkinsonian disability using UPDRS

  • tolerability

  • +1 more secondary outcomes

Interventions

topiramate (drug)DRUG

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • UK PD Society Brain Bank criteria for the diagnosis of idiopathic PD.
  • Patients with stable levodopa-induced dyskinesias present greater than 25% of the day (Unified Parkinson's Disease Rating Scale (UPDRS), item 32, rating \> 2) and be moderately to completely disabling (UPDRS item 33, rating \> 2).
  • All anti-parkinsonian medications must be stable for at least one month prior to study enrollment.

You may not qualify if:

  • Include prior surgery for PD
  • Hoehn and Yahr score of 5 when "off"
  • History of nephrolithiasis
  • Renal impairment
  • Liver disease
  • Pregnancy
  • Premenopausal females and males not using adequate contraception
  • Cognitive impairment (Mini Mental State Exam score less than 24)
  • History of glaucoma or seizures
  • Use of other antiepileptic drugs
  • Amantadine
  • Carbonic anhydrase inhibitors
  • Digoxin
  • Metformin
  • Or illicit drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital, UHN

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Interventions

TopiramatePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Susan H Fox, MRCP, PhD

    UHN, Toronto, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2006

First Posted

February 27, 2006

Study Start

September 1, 2004

Study Completion

March 1, 2007

Last Updated

September 20, 2007

Record last verified: 2007-08

Locations

CA(1)