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

A

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

117 participants in 2 patient groups, including a placebo group

SD-809
Experimental group
Description:
SD-809 tablets taken twice daily for 12 weeks.
Treatment:
Drug: SD-809
Sugar Pill
Placebo Comparator group
Description:
Placebo tablets taken twice daily for 12 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

41

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Data sourced from clinicaltrials.gov

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