Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD)

Auspex Pharmaceuticals

Status and phase

Completed

Phase 3

Phase 2

Conditions

Tardive Dyskinesia

Treatments

Drug: SD-809

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02195700

SD-809-C-18

Details and patient eligibility

About

The purpose of this study is to determine whether an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.

Enrollment

117 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

History of using a dopamine receptor antagonist for at least 3 months
Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening
Subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications
Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months
History of being compliant with prescribed medications
Able to swallow study drug whole
Be in good general health and is expected to attend all study visits and complete study assessments
Female subjects must not be pregnant and agree to an acceptable method of contraception

Exclusion criteria

Currently receiving medication for the treatment of tardive dyskinesia
Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias
Have a serious untreated or undertreated psychiatric illness
Have recent history or presence of violent behavior
Have unstable or serious medical illness
Have evidence of hepatic impairment
Have evidence of renal impairment
Have known allergy to any component of SD-809 or tetrabenazine
Has participated in an investigational drug or device trial and received study drug within 30 days
Have acknowledged use of illicit drugs
Have a history of alcohol or substance abuse in the previous 12 months