Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements

NCT ID: NCT00642057

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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Although the results of studies looking at tetrabenazine have shown its effectiveness in the management of hyperkinetic(too much) movement disorders, it has not been made available in the U.S. The drug must be obtained from Cambridge Laboratories, the distributor, using an individual IND (#16,161). The cost of the drug is passed on to the patient. The purpose of the protocol is to provide an efficacious drug, with few side effects, in an attempt to get rid of a variety of incapacitating dyskinesias (abnormal movements).

Detailed Description

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The purpose of the protocol is to provide compassionate use of an efficacious drug, with few side effects, in an attempt to get rid of a variety of incapacitating dyskinesias (abnormal movements).

Conditions

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Hyperkinetic Movement Disorders

Interventions

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tetrabenazine

25 mg titrated to optimal dose per patient

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects evaluated here at Baylor in the PDCMDC demonstrating need for tetrabenazine treatment.
* Willing to sign informed consent.
* Willing to comply with procedures required as part of this study.

Exclusion Criteria

* Those subjects unwilling to comply with study requirements.
* Subjects unable to give informed consent.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joseph Jankovic

OTHER

Sponsor Role lead

Responsible Party

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Joseph Jankovic

Professor, Neurology-PDCMDC

Responsibility Role SPONSOR_INVESTIGATOR

Related Links

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http://www.jankovic.org

Parkinson's Disease Center and Movement Disorders Clinic

Other Identifiers

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H-721

Identifier Type: -

Identifier Source: org_study_id

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