An Open-label Study to Define the Safety, Tolerability and Clinical Activity of Deutetrabenazine (AUstedo) in Adult Study Subjects With DYsTonia (AUDYT)

This is an interventional treatment trial for Dystonia, Primary Read More

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 subjects able to read and understand English and the ICF and are willing to comply with all study procedures, treatment and follow-up.
4. Study subjects who are taking any central nervous system acting medications (e.g., benzodiazepines, antidepressants, hypnotics), including medications for the treatment of dystonia, will be on a stable regimen for at least 30 days prior to the screening Visit, and will willing to remain on the same dose for the duration of the study.
5. Female of child-bearing potential will not be pregnant and will be using an acceptable method of contraception.
6. Study subjects with an MMSE >24.

Exclusion Criteria:

1. Exposure to dopamine blockers prior to the onset of dystonia that could, in the investigator's opinion, have caused dystonia.
2. Study subjects with genetically-confirmed dopa-responsive dystonia.
3. Study subjects with a diagnosis of Parkinson's or an atypical parkinsonian syndrome.
4. Study subjects with a history of bipolar disorder or major depression, or the presence of active depression.
5. Study subjects with a history of a suicide attempt or suicidal ideations, as well as the presence of active suicidal ideation as detailed on the C-SSRS administered during Visit 1.
6. Study subjects with a history of schizophrenia or schizophrenia spectrum disorders.
7. Treatment with tetrabenazine, reserpine, valbenazine, a monoamino oxidase inhibitor, a-methyl-p-tyrosine, strong anticholinergic medications, metoclopramide, antipsychotics, dopamine agonists, levodopa, and/or stimulants within 30 days of screening.
8. Treatment with botulinum toxin less than 11 weeks prior to screening (Visit 1); subjects receiving injections sooner than every 12 weeks will be excluded if their next injection is scheduled farther than 6 days from screening.
9. Presence of a neurologic condition that could confound dystonia assessments.
10. Study subjects with a history of clinically relevant hepatic disease.
11. Study subjects with a history of renal insufficiency.
12. Any unstable medical illness.
13. A corrected QT (Bazett) interval of 450 (458) milliseconds in men or 460 (472) milliseconds in women on 12-lead ECG at screening, or a history of cardiac arrhythmias.
14. Study subjects participating in any drug or device clinical investigation concurrently or within 30 days prior to screening for this study.
15. Study subjects with a known hypersensitivity or contraindication to the study drug or its components.