NCT00036296

Brief Summary

The purpose of this research study is to test the safety and effectiveness of the study drug, Talampanel, when used to treat patients with involuntary movements known as dyskinesias, as a result of treatment to Parkinson's disease. It is not clear why people with Parkinson's disease develop involuntary movements (dyskinesias) but studies show that blocking receptors in the brain for a chemical called glutamate decreases these movements. Talampanel is a drug which blocks these receptors.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_1

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 9, 2002

Completed
4.6 years until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

April 13, 2011

Status Verified

October 1, 2009

Enrollment Period

2 months

First QC Date

May 8, 2002

Last Update Submit

April 11, 2011

Conditions

DyskinesiasParkinson DiseaseMovement Disorders

Keywords

Involuntary MovementsAbnormal MovementsAdvanced Parkinson's diseaseLevodopa induced dyskinesia

Study Arms (2)

1

EXPERIMENTAL

75mg per day (in 3 doses) Talampanel for 22 days

Drug: talampanel

2

PLACEBO COMPARATOR

3 doses a day for 22 days

Drug: talampanel

Interventions

talampanelDRUG

75mg per day divided into 3 doses for 22 days

12

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Troublesome on-period dyskinesias as defined by a Unified Parkinson's Disease Rating Scale (UPDRS) dyskinesia sub-score \>25% of Duration of dyskinesia during waking hours and 33 must have moderate disability
  • Lang-Fahn dyskinesia rating score more than 2 for at least two of the 5 tasks
  • Must have Dyskinesia on average 25% of waking hours/day based on Patient Diaries
  • Have been diagnosed with Parkinson's disease \> 5 years at Screening

You may not qualify if:

  • Previous surgical therapies for PD
  • Isolated or predominantly diphasic dyskinesias
  • Moderate Dementia
  • On disallowed concomitant medications including CYP3A4 inhibitors and inducers, amantadine, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DyskinesiasParkinson DiseaseMovement Disorders

Interventions

talampanel

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 8, 2002

First Posted

May 9, 2002

Study Start

December 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

April 13, 2011

Record last verified: 2009-10