Hyperkinetic Movement DisordersTBZNCT00642057
Compassionate Use of Tetrabenazine in the Treatment of Abnormal Movements
A study testing tetrabenazine in people with Hyperkinetic Movement Disorders, run by Joseph Jankovic.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperkinetic Movement Disorders
- What is being tested?
- tetrabenazine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those subjects unwilling to comply with study requirements.
- Subjects unable to give informed consent.
About this study
Official title: Compassionate Use of Tetrabenazine in the Treatment of Hyperkinesias
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).
Read the 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).
- Conditions
- Hyperkinetic Movement Disorders
- Being tested
- tetrabenazine
- Keywords
- chorea, dyskinesia, hyperkinetic
- Medical subject headings
- Chorea, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tetrabenazineDrug
25 mg titrated to optimal dose per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperkinetic Movement DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Joseph Jankovic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph Jankovic, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642057
- Sponsor's protocol ID
- H-721
- Acronym
- TBZ
- Status last verified
- Mar 2023
- First submitted
- 28 Dec 2007
- Last updated
- 24 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Tetrabenazine in the Treatment of Hyperkinesias
- ClinicalTrials.gov ID
- NCT00642057
- Acronym / sponsor ID
- TBZ / H-721
- Conditions
- Hyperkinetic Movement Disorders
- Keywords
- chorea, dyskinesia, hyperkinetic
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Joseph JankovicUniversity, hospital or other
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Those subjects unwilling to comply with study requirements.
- Subjects unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tetrabenazine25 mg titrated to optimal dose per patient | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Parkinson's Disease Center and Movement Disorders ClinicLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing tetrabenazine in people with Hyperkinetic Movement Disorders, run by Joseph Jankovic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.