Reducing Involuntary Movements in Tardive Dyskinesia



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:6/7/2018
Start Date:October 20, 2014
End Date:December 18, 2020

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An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of
SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe
tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809
following one week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks
maintenance with SD-809.


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

- Subject has successfully completed a controlled study of SD-809 for treatment of
moderate to severe tardive dyskinesia

- 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
We found this trial at
47
sites
Lincoln, Nebraska 68510
1256
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Lincoln, NE
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Albuquerque, New Mexico 87102
649
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Albuquerque, NM
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Anaheim, California
17
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Anaheim, CA
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Anaheim, California
17
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Anaheim, CA
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2057
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Augusta, GA
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Baltimore, Maryland
2301
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Baltimore, MD
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Boca Raton, Florida
2312
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Boca Raton, FL
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Charleston, South Carolina
2184
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Charleston, SC
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Chicago, Illinois
1729
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Chicago, IL
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Chicago, Illinois
1729
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Chicago, IL
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Creve Coeur, Missouri
1561
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Creve Coeur, MO
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Decatur, Georgia
1924
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Decatur, GA
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Englewood, Colorado
815
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Englewood, CO
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Fort Worth, Texas
1194
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Fort Worth, TX
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Gainesville, Florida
2105
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Gainesville, FL
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Garfield Heights, Ohio 44125
2036
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Garfield Heights, OH
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Glen Burnie, Maryland
2301
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Glen Burnie, MD
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Glendale, California
14
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Glendale, CA
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6059
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Havirov,
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Irvine, California
29
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Irvine, CA
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Irvine, California
29
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Irvine, CA
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Kansas City, Missouri
1341
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Kansas City, MO
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Lake City, Florida
2076
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Lake City, FL
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Loma Linda, California
43
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Loma Linda, CA
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Los Angeles, California
13
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Los Angeles, CA
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Los Angeles, California
13
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Los Angeles, CA
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Memphis, Tennessee
1586
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Memphis, TN
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2320
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Miami, FL
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2320
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Miami, FL
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New Haven, Connecticut
2486
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New Haven, CT
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Norwalk, California
12
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Norwalk, CA
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Oceanside, California
70
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Oceanside, CA
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Oceanside, California
70
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Oceanside, CA
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Orange, California
21
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Orange, CA
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2184
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Orlando, FL
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Port Charlotte, Florida
2181
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Port Charlotte, FL
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Raleigh, North Carolina
2218
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Raleigh, NC
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Richland, Washington
846
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Richland, WA
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Saint Louis, Missouri
1573
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Saint Louis, MO
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Salt Lake City, Utah
570
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Salt Lake City, UT
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Salt Lake City, Utah
570
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San Bernardino, California 92408
41
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San Diego, California
105
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San Rafael, California
13
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San Rafael, CA
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Tuscaloosa, Alabama
1745
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Tuscaloosa, AL
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Washington, District of Columbia
2281
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Washington,
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Waukesha, Wisconsin
1712
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Waukesha, WI
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