RIM-TD

Principal Investigator: David Shprecher
Keywords: Tardive Dyskinesia , Involuntary Movement , SD-809 (Deutetrabenazine) Department: Neurology
IRB Number: 00076876 Co Investigator: Behrang Saminejad
Specialty: Neurology
Sub Specialties: Movement Disorders
Recruitment Status: Enrolling by invitation

Contact Information

Paola Wall
paola.wall@hsc.utah.edu
801-581-4543

Brief Summary

The purpose of this study is to evaluate how well an investigational drug, SD-809 (deutetrabenazine), works long-term to reduce the severity of abnormal involuntary movements of tardive dyskinesia.  

The objectives of this study are:
• Evaluate the safety and tolerability of long-term maintenance therapy with SD-809
• Evaluate the efficacy of long-term maintenance therapy of SD-809 to reduce the severity of
abnormal involuntary movements of TD

Inclusion Criteria

Participant Inclusion Criteria:

1. Subject is at least 18 years of age at Screening.
2. Subject has successfully completed Study SD-809-C-18, Study SD-809-C-23, or any other controlled study of SD-809 for treatment of moderate to severe TD. 
of SD-809 for treatment of moderate to severe TD
3. Subject has a history of using a dopamine receptor antagonist for at least 3 months (or
1 month in subjects 60 years of age and older). See Appendix 15.
4. Subject has a clinical diagnosis of TD and has had symptoms for at least 3 months
prior to Screening.
5. For subjects with underlying psychiatric illness:
• Subject is psychiatrically stable and has had no change in psychoactive
medications (including, but not limited to, neuroleptics, benzodiazepines,
anticonvulsants, and mood stabilizers) for ≥30 days before Screening (45 days for
antidepressants).
• Subjects on long acting (depot) medications have been on stable therapy (dose,
frequency) for ≥3 months before Screening.
• Subject has a health care provider who is aware of the subject’s participation in
the trial, and does not anticipate any changes in the subject’s treatment regimen
(drug, dose, frequency) in the next 3 months.
6. Subject has a history of being compliant with prescribed medications.
7. Subject is able to swallow study drug whole.
8. Subject has provided written, informed consent or, if subject lacks the capacity to
provide informed consent, a legally authorized representative (LAR) has provided
written informed consent and the subject has provided assent.
9. In the opinion of the Investigator, the subject lives in a stable environment, and has
adequate supervision when necessary to comply with all study procedures, attend all
study visits, and safely participate in the trial.
10. Subject has sufficient reading skills to comprehend the subject-completed rating
scales.
11. Female subjects of childbearing potentialb agree to use one of the following
acceptable methods of contraception from Screening through study completion if
sexually active:
• IUD or intrauterine system in place for at least 3 months prior to screening;
• Subject or partner using barrier method (e.g., condom, diaphragm, or cervical
cap) with spermicide from Screening through study completion;
• Partner has a documented vasectomy >6 months prior to enrollment.
• Stable hormonal contraception (with approved oral, transdermal, or depot
regimen) for at least 3 months prior to Screening.

Exclusion Criteria

Participant Exclusion Criteria

1. Subject has received tetrabenazine within 7 days of Baseline.
2. Subject has received any of the following medications within 30 days of Baseline:
• Reserpine, α-methyl-p-tyrosine (AMPT), botulinum toxin (within 3 months of
Baseline), and medications with strong anticholinergic activity (trihexyphenidyl,
benztropine, orphenadrine, procyclidine, and biperiden)
• Metoclopramide, promethazine, and prochlorperazine
• Stimulants(i.e., methylphenidate, amphetamine/dextroamphetamine,
lisdexamphetamine, etc.), or monoamine oxidase inhibitors (MAOIs)
• Levodopa or dopamine agonists
3. Subject has a neurological condition other than TD that may interfere with assessing
the severity of dyskinesias.
4. Subject has a serious untreated or undertreated psychiatric illness at Baseline.
5. Subject has active suicidal ideation at Baseline.
6. Subject has a history of any of the following within 6 months of Baseline:
• Previous intent to act on suicidal ideation with a specific plan (positive answer to
question 5 on C-SSRS), irrespective of level of ambivalence at the time of suicidal
thought
• Previous preparatory acts to commit suicide or suicidal behavior
• A previous actual, interrupted, or aborted suicide attempt
7. Subject has a score ≥11 on the depression subscale of the Hospital Anxiety and
Depression Scale (HADS) at Baseline.
8. Subject is developmentally disabled or has evidence of dementia.
9. Subject has an unstable or serious medical illness at Baseline.
10. Subject has history (within 3 months) or presence of violent behavior.
11. Subject has a QTcF value >450 ms (males) or >460 ms (females), or >480 ms (with
right bundle branch block [RBBB]) on 12-lead electrocardiogram (ECG) at Baseline.
12. Subject has evidence of hepatic impairment at Screening of the parent study, as indicated by:
• Aspartate transaminase (AST) or alanine aminotransferase (ALT) >2.5 times the
upper limit of normal (ULN).
• Alkaline phosphatase (ALP) or total bilirubin (TBil) >2 times the ULN
o Note: Subjects with Gilbert’s Syndrome are eligible to participate if approved
by the medical monitor.
o Note: Subjects with abnormalities in two or more of these analytes (AST,
ALT, ALP, TBil) must be approved by the Medical Monitor to be enrolled.
• Prothrombin time >17 seconds (i.e., prothrombin time prolonged >4 seconds over the ULN
• Positive hepatitis B surface antigen (HBsAg).
13. Subject has evidence of significant renal impairment at Screening of the parent study, indicated by a creatinine clearance <50 mL/min, as estimated by the Cockroft-Gault formula.
14. Subject has known allergy to tetrabenazine or to any of the components of SD-809.
15. Subject has participated in an investigational drug or device trial (other than Study
SD-809-C-18, study SD-809-C-23, or any other eligible SD-809 parent study) and received study drug within 30 days (or 5 drug half-lives) of Baseline, whichever is longer.
16. Subject is pregnant or breast-feeding at Baseline.
17. Subject acknowledges present use of illicit drugs at Baseline.
18. Subject has a history of alcohol or substance abuse in the previous 12 months, as
defined in the DSM-V, or subject is unable to refrain from substance abuse
throughout the study.