A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FIXED-DOSE STUDY OF SD-809 (DEUTETRABENAZINE) FOR THE TREATMENT OF MODERATE TO SEVERE TARDIVE DYSKINESIA - AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia)

Auspex Pharmaceuticals, Inc.0 个研究点目标入组 200 人开始时间: 2015年1月27日最近更新: 2016年10月3日

适应症

试验速览

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•- 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 142
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 58

•- 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

发起方