First Time Use of SD-809 in Huntington Disease (First-HD)

Study Description

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Brief Summary:

The purpose of this study is to determine whether SD-809 tablets are effective in the treatment of chorea associated with Huntington's Disease.

Condition or disease	Intervention/treatment	Phase
Chorea	Drug: SD-809; Drug: Placebo	Phase 3

Detailed Description:

This is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of SD-809 for the treatment of chorea associated with Huntington's Disease. Approximately 90 subjects will be randomized (1:1) into the study, with approximately 45 subjects receiving SD-809 and 45 subjects receiving placebo. The study will be conducted at approximately 30 centers in the U.S. and Canada.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Randomized Double-Blind, Placebo-Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease
Actual Study Start Date :	August 5, 2013
Actual Primary Completion Date :	December 5, 2014
Actual Study Completion Date :	December 5, 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: SD-809 ER Tablets; SD-809 ER tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). All are administered three times a day, with the 6 mg final dose is placebo.	Drug: SD-809; SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).; Other Name: deutetrabenazine Drug: Placebo; Placebo tablets are identical in appearance to SD-809 tablets.
Experimental: SD-809 Tablets; SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). All are administered three times a day, with the 6 mg final dose is placebo.	Drug: SD-809; SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).; Other Name: deutetrabenazine Drug: Placebo; Placebo tablets are identical in appearance to SD-809 tablets.

Outcome Measures

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Primary Outcome Measures :

1. Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12 [ Time Frame: Screening, Day 0, Weeks 9, 12 ]
   Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea

Secondary Outcome Measures :

1. Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC) [ Time Frame: 12 weeks ]
   A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved
2. Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) [ Time Frame: 12 weeks ]
   A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved. The clinician was asked to comment about the subject.
3. Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12 [ Time Frame: Baseline, 12 weeks ]
   Change in the Short Form 36 Health Survey (SF-36) physical functioning score (based on items 3a to 3j) from Baseline to Week 12. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
4. Change in Berg Balance Test (BBT) [ Time Frame: Baseline, 12 weeks ]
   The Berg Balance Test (BBT) is a 14-item assessment of sitting, standing, transferring, and turning. Each task ranging from standing up from a sitting position, to standing on one foot each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.The scale range, which is 0-56, with higher scores indicating better balance/lower fall risk.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Subject is at least 18 years of age or the age of majority (whichever is older) at Screening.
• Subject has been diagnosed with manifest HD
• Subject is able to swallow study medication whole.
• Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion.
• The subject has a reliable caregiver who interacts with the patient on a daily basis, oversees study drug administration, assures attendance at study visits and participates in evaluations, as required.
• Subject is able to ambulate without assistance for at least 20 yards (Note: The use of assistive devices (i.e., walker, cane) is permitted during ambulation).

Exclusion Criteria:

• Subject has a serious untreated or under-treated psychiatric illness, such as depression, at Screening or Baseline.
• Subject has active suicidal ideation at Screening or Baseline.
• Subject has history of suicidal behavior at Screening or Baseline:
• Subject has evidence for depression at Screening or Baseline.
• Subject has an unstable or serious medical or psychiatric illness at Screening or Baseline.
• Subject has been recently exposed to tetrabenazine.

• Subject has received any of the following concomitant medications within 30 days of Screening or Baseline:

  • Antipsychotics
  • Metoclopramide
  • Monoamine oxidase inhibitors (MAOI)
  • Levodopa or dopamine agonists
  • Reserpine
  • Amantadine
  • Memantine
• Subject has significantly impaired swallowing function at Screening.
• Subject has significantly impaired speaking at Screening.
• Subject requires treatment with drugs known to prolong the QT interval.
• Subject has a prolonged QT interval on 12-lead ECG at Screening.
• Subject has evidence of hepatic impairment at Screening.
• Subject has evidence of significant renal impairment at Screening.
• Subject has known allergy to any of the components of study medication.
• Subject has participated in an investigational drug or device trial within 30 days (or 5 drug half-lives) of Screening, whichever is longer.
• Subject is pregnant or breast-feeding at Screening or Baseline.
• Subject acknowledges present use of illicit drugs at Screening.
• Subject has a history of alcohol or substance abuse in the previous 12 months.

Contacts and Locations

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  Show 43 Study Locations

Sponsors and Collaborators

Teva Pharmaceutical Industries

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Claassen DO, Carroll B, De Boer LM, Wu E, Ayyagari R, Gandhi S, Stamler D. Indirect tolerability comparison of Deutetrabenazine and Tetrabenazine for Huntington disease. J Clin Mov Disord. 2017 Mar 1;4:3. doi: 10.1186/s40734-017-0051-5. eCollection 2017.

Huntington Study Group, Frank S, Testa CM, Stamler D, Kayson E, Davis C, Edmondson MC, Kinel S, Leavitt B, Oakes D, O'Neill C, Vaughan C, Goldstein J, Herzog M, Snively V, Whaley J, Wong C, Suter G, Jankovic J, Jimenez-Shahed J, Hunter C, Claassen DO, Roman OC, Sung V, Smith J, Janicki S, Clouse R, Saint-Hilaire M, Hohler A, Turpin D, James RC, Rodriguez R, Rizer K, Anderson KE, Heller H, Carlson A, Criswell S, Racette BA, Revilla FJ, Nucifora F Jr, Margolis RL, Ong M, Mendis T, Mendis N, Singer C, Quesada M, Paulsen JS, Brashers-Krug T, Miller A, Kerr J, Dubinsky RM, Gray C, Factor SA, Sperin E, Molho E, Eglow M, Evans S, Kumar R, Reeves C, Samii A, Chouinard S, Beland M, Scott BL, Hickey PT, Esmail S, Fung WL, Gibbons C, Qi L, Colcher A, Hackmyer C, McGarry A, Klos K, Gudesblatt M, Fafard L, Graffitti L, Schneider DP, Dhall R, Wojcieszek JM, LaFaver K, Duker A, Neefus E, Wilson-Perez H, Shprecher D, Wall P, Blindauer KA, Wheeler L, Boyd JT, Houston E, Farbman ES, Agarwal P, Eberly SW, Watts A, Tariot PN, Feigin A, Evans S, Beck C, Orme C, Edicola J, Christopher E. Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):40-50. doi: 10.1001/jama.2016.8655.

Responsible Party:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT01795859 History of Changes
Other Study ID Numbers:	SD-809-C-15
First Posted:	February 21, 2013
Results First Posted:	August 11, 2017
Last Update Posted:	September 20, 2017
Last Verified:	August 2017

Keywords provided by Teva Pharmaceutical Industries:

Huntington disease; Chorea; Tetrabenazine

Additional relevant MeSH terms:

Huntington Disease; Chorea; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Cognition Disorders	Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Tetrabenazine; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Adrenergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs