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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Chorea

Treatments: Drug: Placebo; Drug: SD-809

Study type: Interventional

Funder types: Industry

Identifiers

NCT01795859

SD-809-C-15

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

SD-809 ER Tablets

Experimental group

Description:

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.

Treatment:

Drug: SD-809

Drug: Placebo

SD-809 Tablets

Experimental group

Description:

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.

Treatment:

Drug: SD-809

Drug: Placebo