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

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ClinicalTrials.gov Identifier: NCT00642057
Expanded Access Status : Available (Commercial availability of Xenazine)
First Posted : March 24, 2008
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Christine Hunter, Baylor College of Medicine

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).

Condition or disease Intervention/treatment
Hyperkinetic Movement Disorders Drug: tetrabenazine

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).

Study Type : Expanded Access
Official Title: Compassionate Use of Tetrabenazine in the Treatment of Hyperkinesias
Study Start Date : June 1989
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: tetrabenazine
    25 mg titrated to optimal dose per patient

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642057


Contacts
Contact: Christine Hunter, RN 713-798-3951 chunter@bcm.edu

Sponsors and Collaborators
Christine Hunter

Additional Information:
Responsible Party: Christine Hunter, Research Manager, PDCMDC, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00642057     History of Changes
Other Study ID Numbers: H-721
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by Christine Hunter, Baylor College of Medicine:
chorea
dyskinesia
hyperkinetic

Additional relevant MeSH terms:
Movement Disorders
Hyperkinesis
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Tetrabenazine
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs