Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Deutetrabenazine · 1 trial · 1 indication
Proportion of study subjects able to titrate up to 48 mg/d (or up to 36 mg/d if receiving a strong CYP2D6 inhibitor) and able to complete the study at this dosage
| Arm | Type | Description |
|---|---|---|
| Intervention arm - Oral Deutetrabenazine | EXPERIMENTAL | This is the only arm for this trial. All subjects will receive oral Deutetrabanazine. |
| Name | Type | Description |
|---|---|---|
| Deutetrabenazine 6 MG | DRUG | Increasing doses of Deutetrabenazine |
Inclusion Criteria: 1. Study subjects with definite dystonia, as established by a movement disorder specialist. 2. Study subjects of any race and either gender, age 18 or more on the date the informed consent form (ICF) is signed and with the capacity to provide voluntary informed consent. 3. Study...
Deutetrabenazine is an investigational small molecule being studied for the treatment of primary dystonia, a neurological movement disorder. It is being evaluated for its safety, tolerability, and clinical activity in adult patients with this condition. The drug is not yet approved for this indication and remains in clinical development.
Deutetrabenazine is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker TEVA. Teva is conducting clinical research to evaluate the drug's potential in treating primary dystonia.
Deutetrabenazine is in Phase 1 clinical development for primary dystonia. A Phase 1 study has been completed, and the drug remains investigational. It has not been approved by regulatory authorities for this use, and further clinical trials would be needed to establish its safety and efficacy.
Deutetrabenazine has been studied in one completed clinical trial, NCT04173260, titled "An Open-label Study to Define the Safety, Tolerability and Clinical Activity of Deutetrabenazine (AUstedo) in Adult Study Subjects With DYsTonia." This Phase 1 trial enrolled 15 adult participants in the United States and was not randomized or blinded.
Deutetrabenazine is a small molecule designed to modulate neurotransmitter activity in the brain. It is being investigated for its ability to reduce abnormal involuntary movements associated with primary dystonia. The exact mechanism of action in this condition is under evaluation in clinical studies.