NCT04301726

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Fundacion Huntington Puerto Rico · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy of deutetrabenazine to control symptoms of dysphagia associated with HD.

Detailed description

The primary endpoint is the change in swallow function/dysphagia from baseline to maintenance therapy.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2022-01-21
• Primary completion: 2023-08-18
• Completion: 2023-09-01
• First posted: 2020-03-10
• Last updated: 2025-02-27

Locations

1 site across 1 country: Puerto Rico