Clinical Trials Logo

Clinical Trial Summary

The purpose of this research study is to see if tetrabenazine, which is commonly used to treat Huntington's Disease (HD), reduces the problems of impulsivity that are common in patients with HD. Investigators will also see how the medicine affects aspects of thinking and mood.


Clinical Trial Description

This study is an open-label assessment of behavioral symptoms including depression, impulsivity, and suicidal ideations in patients prior to, and after, taking a stable dose of TBZ for Huntington's disease. All subjects will be evaluated with tests of depression (Beck Depression Scale), impulsivity (QUIP, BIS-11, and computerized impulsivity scales), and suicidal ideation (Columbia Suicide Scale) as a safety measure before they actually start taking TBZ. Since there is a significant lack of awareness of emotional and cognitive symptoms (anosagnosia) in patients with HD, collateral sources will be asked to fill out similar questionnaires based on their knowledge and observation of the patient. Patients and collaterals will be asked to return to the clinic for an identical evaluation plus adverse events, after they have been on a stable dose of TBZ for 4 weeks, which would be 8 ± 1 week after initiating TBZ. Patients will be titrated over 3-5 weeks to best dose as determined by the investigator, up to a maximum of 75 mg/day. As patients are titrating, there will be several telephone contacts conducted. The initial dose will be 12.5 mg BID. Best dose will be largely determined by adverse events and subjective efficacy. Determination of best dose will include two scheduled phone calls and others as needed. Other medications will remain stable between visits. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02509793
Study type Interventional
Source The Methodist Hospital Research Institute
Contact William G Ondo, MD
Phone 713-363-8390
Email wondo@houstonmethodist.org
Status Recruiting
Phase Phase 4
Start date August 1, 2018
Completion date July 1, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04120493 - Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease Phase 1/Phase 2
Completed NCT02956148 - Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers Early Phase 1
Terminated NCT02494778 - A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease Phase 2
Completed NCT02208934 - Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers Phase 1
Completed NCT02197130 - Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease Phase 2
Completed NCT02216474 - Brain Stimulation in Movement Disorders N/A
Completed NCT01806896 - Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease Phase 2
Completed NCT01502046 - Neuroprotection by Cannabinoids in Huntington's Disease Phase 2
Terminated NCT00712426 - Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E) Phase 3
Completed NCT00670709 - Examination of Quantitative Electroencephalographic (QEEG) Biomarkers in Huntington's Disease
Completed NCT00029874 - Minocycline in Patients With Huntington's Disease Phase 1/Phase 2
Terminated NCT02231580 - Study Exploring Safety, Pharmacokinetic and Pharmacodynamic of BN82451 in Male Huntington's Disease Patients Phase 2
Completed NCT02215616 - A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod Phase 2
Not yet recruiting NCT02551705 - Functional Imaging of Social Cognition in Premanifest Huntington's Disease N/A
Active, not recruiting NCT02101957 - Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103) Phase 2/Phase 3
Completed NCT01521832 - Escalating Dose Study in Healthy Volunteers With SEN0014196 Phase 1
Completed NCT00990613 - A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin Phase 1
Completed NCT00975481 - A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users Phase 1
Completed NCT00387270 - Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease Phase 1/Phase 2
Completed NCT00095355 - Effects of Lithium and Divalproex`on Brain-Derived Neurotrophic Factor in Huntington's Disease Phase 2