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Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements (TBZ)

Primary Purpose

Hyperkinetic Movement Disorders

Status

No longer available

Phase

Locations

Study Type

Expanded Access

Intervention

tetrabenazine

About this trial

This is an expanded access trial for Hyperkinetic Movement Disorders focused on measuring chorea, dyskinesia, hyperkinetic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00642057

First Posted

December 28, 2007

Last Updated

March 22, 2023

Sponsor

Joseph Jankovic

1. Study Identification

Unique Protocol Identification Number

NCT00642057

Brief Title

Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements

Acronym

TBZ

Official Title

Compassionate Use of Tetrabenazine in the Treatment of Hyperkinesias

Study Type

Expanded Access

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

No longer available

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Joseph Jankovic

4. Oversight

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

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

Hyperkinetic Movement Disorders

Keywords

chorea, dyskinesia, hyperkinetic

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

tetrabenazine

Intervention Description

25 mg titrated to optimal dose per patient

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Links:

URL

http://www.jankovic.org

Description

Parkinson's Disease Center and Movement Disorders Clinic

Learn more about this trial

Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements

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