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Small Molecule

Branaplam for Huntington's disease (VIBRANT-HD Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 2 years

Summary

This trial tests branaplam, a drug aimed at lowering harmful protein levels, in adults with early-stage Huntington's Disease. The goal is to see if reducing these proteins can help manage the disease by slowing its progression. Branaplam is being investigated for its potential to lower harmful protein levels in Huntington's Disease.

Eligible Conditions
  • Huntington's disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of treatment emergent adverse events and serious adverse events
Reduction (%) of mHTT protein in cerebrospinal fluid (CSF)
Secondary study objectives
Area under the curve (AUC) of UFB112 in plasma
Area under the curve (AUC) of branaplam in plasma
Change from baseline in Ventricular Volume, Caudate Volume and Total Brain Volume
+16 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Arm C or X or YExperimental Treatment1 Intervention
(C) Branaplam 154 mg oral solution once weekly, OR (X) Branaplam 84 mg oral solution once weekly OR (Y) Branaplam 28 mg oral solution once weekly
Group II: Treatment Arm BExperimental Treatment1 Intervention
Branaplam 112 mg oral solution once weekly
Group III: Treatment Arm AExperimental Treatment1 Intervention
Branaplam 56 mg oral solution once weekly
Group IV: PlaceboPlacebo Group1 Intervention
Matching placebo oral solution once weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Branaplam
2021
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,905 Previous Clinical Trials
4,208,089 Total Patients Enrolled

Media Library

Huntington's disease Research Study Groups: Treatment Arm A, Treatment Arm B, Treatment Arm C or X or Y, Placebo
Huntington's disease Clinical Trial 2023: Branaplam Highlights & Side Effects. Trial Name: NCT05111249 — Phase 2
~7 spots leftby Nov 2025
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