Effects of Talampanel on Patients With Advanced Parkinson's Disease

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

talampanel

About this trial

This is an interventional treatment trial for Dyskinesias focused on measuring Involuntary Movements, Abnormal Movements, Advanced Parkinson's disease, Levodopa induced dyskinesia

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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

3 doses a day for 22 days

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00036296

First Posted

May 8, 2002

Last Updated

April 11, 2011

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00036296

Brief Title

Effects of Talampanel on Patients With Advanced Parkinson's Disease

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyskinesias, Parkinson Disease, Movement Disorders

Keywords

Involuntary Movements, Abnormal Movements, Advanced Parkinson's disease, Levodopa induced dyskinesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Description

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

Arm Title

2

Arm Type

Placebo Comparator

Arm Description

3 doses a day for 22 days

Intervention Type

Drug

Intervention Name(s)

talampanel

Intervention Description

75mg per day divided into 3 doses for 22 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Dyskinesias, Parkinson Disease, Movement Disorders

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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