Effects of Talampanel on Patients With Advanced Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00036296
• Date of registration: 08/05/2002
• Prospective Registration: Yes
• Primary sponsor: Teva Pharmaceutical Industries
• Public title: Effects of Talampanel on Patients With Advanced Parkinson's Disease
• Scientific title: Effects of Talampanel on Patients With Advanced Parkinson's Disease Who Have Been on Sinemet for More Than 5 Years and Have Dyskinesia (Abnormal Involuntary Movements)
• Date of first enrolment: December 2006
• Target sample size: 22
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00036296
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Canada, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- Previous surgical therapies for PD

- Isolated or predominantly diphasic dyskinesias

- Moderate Dementia

- On disallowed concomitant medications including CYP3A4 inhibitors and inducers,
amantadine, etc.



Age minimum: 40 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dyskinesias

Movement Disorders

Parkinson Disease

Intervention(s)

Drug: talampanel

Secondary ID(s)

IXL-202-18-189

Source(s) of Monetary Support

Please refer to primary and secondary sponsors