Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements

NCT00642057 | Unknown

• 1 other identifier: H-721
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hyperkinetic Movement Disorders

Keywords

chorea; dyskinesia; hyperkinetic

Interventions

tetrabenazine DRUG

25 mg titrated to optimal dose per patient

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Those subjects unwilling to comply with study requirements.
• Subjects unable to give informed consent.

Sponsors & Collaborators

• Joseph Jankovic: lead

Related Links

• Parkinson's Disease Center and Movement Disorders Clinic

MeSH Terms

Conditions

Chorea; Dyskinesias

Interventions

Tetrabenazine

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinolizines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Neurology-PDCMDC

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: March 24, 2008
• Last Updated: March 24, 2023

Record last verified: 2023-03