Addressing Involuntary Movements in Tardive Dyskinesia (AIM-TD)

Auspex Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Tardive Dyskinesia

Treatments: Drug: Placebo; Drug: SD-809

Study type: Interventional

Funder types: Industry

Identifiers

NCT02291861

SD-809-C-23

2014-003135-19 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 298 patients

Sex: All

Ages: 18 to 80 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 must agree to an acceptable method of contraception throughout the study

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 or device within 30 days
• Have acknowledged use of illicit drugs
• Have a history of alcohol or substance abuse in the previous 12 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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298 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo tablets taken twice daily for 12 weeks.

Treatment:

Drug: Placebo

SD-809 12 mg/day

Experimental group

Description:

SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.

Treatment:

Drug: SD-809

SD-809 24 mg/day

Experimental group

Description:

SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.

Treatment:

Drug: SD-809

SD-809 36 mg/day

Experimental group

Description:

SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.

Treatment:

Drug: SD-809