Clinical Trials Logo

Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT00642057
Other study ID # H-721
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information

Verified date March 2023
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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).


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).


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Drug:
tetrabenazine
25 mg titrated to optimal dose per patient

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Joseph Jankovic