Trial | NCT04301726  Report issue

Title

Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated With HD
Efficacy of Deutetrabenazine in Huntington's Disease Patients With Dysphagia: A Randomised, Placebo-controlled Pilot Study

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    48
To determine the efficacy of deutetrabenazine to control symptoms of dysphagia associated with HD.
The primary endpoint is the change in swallow function/dysphagia from baseline to maintenance therapy.
Study Started
Sep 01
2020
Anticipated
Primary Completion
Apr 30
2022
Anticipated
Study Completion
Dec 31
2022
Anticipated
Last Update
Jul 21
2020

Drug Deutetrabenazine Oral Tablet [Austedo]

The participants randomized to this group will receive oral deutetrabenazine for 8 weeks. Week 1: 6 mg tab once daily; Week 2: 6 mg tab (BID); Week 3: 9 mg tab (BID); Week 4: 12 mg tab (BID); Week 5: 15 mg (6 mg tab + 9 mg tab BID); Week 6: 18 mg (9 mg tab + 9 mg tab BID); Week 7: 21 mg (9 mg tab + 12 mg tab BID); Week 8: 24 mg (12 mg tab BID).

  • Other names: Austedo

Drug Placebo oral tablet

The participants randomized to this group will receive oral placebo for 8 weeks. Week 1: 6 mg tab once daily; Week 2: 6 mg tab (BID); Week 3: 9 mg tab (BID); Week 4: 12 mg tab (BID); Week 5: 15 mg (6 mg tab + 9 mg tab BID); Week 6: 18 mg (9 mg tab + 9 mg tab BID); Week 7: 21 mg (9 mg tab + 12 mg tab BID); Week 8: 24 mg (12 mg tab BID).

  • Other names: Placebo

Deutetrabenazine Experimental

The participants randomized to this group will receive oral deutetrabenazine for 8 weeks. Week 1: 6 mg once daily; Week 2: 6 mg twice daily (BID); Week 3: 9 mg BID; Week 4: 12 BID; Week 5: 15 mg BID; Week 6: 18 mg BID; Week 7: 21 mg BID; Week 8: 24 mg BID.

Placebo Placebo Comparator

The participants randomized to this group will receive oral placebo for 8 weeks. Week 1: 6 mg once daily; Week 2: 6 mg twice daily (BID); Week 3: 9 mg BID; Week 4: 12 BID; Week 5: 15 mg BID; Week 6: 18 mg BID; Week 7: 21 mg BID; Week 8: 24 mg BID.

Criteria 

Inclusion Criteria:

Confirmed diagnosis of HD
Symptoms of dysphagia
Must be able to swallow tablets

Exclusion Criteria:

Other confounding diseases that affect swallowing
Depression
Hepatic impairment
Renal impairment
Dementia
No Results Posted