Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated with HD

Fundacion Huntington Puerto Rico

Status and phase: Terminated; Phase 1

Conditions: Huntington Disease

Treatments: Drug: Placebo oral tablet; Drug: Deutetrabenazine Oral Tablet [Austedo]

Study type: Interventional

Funder types: Other

Identifiers

NCT04301726

2002027824

Details and patient eligibility

About

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

Full description

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

Enrollment: 36 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

Deutetrabenazine

Experimental group

Description:

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.

Treatment:

Drug: Deutetrabenazine Oral Tablet [Austedo]

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo oral tablet