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Small Molecule

Branaplam for Huntington 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
Awards & highlights

VIBRANT-HD Trial Summary

This trial is testing a new drug to see if it can lower the amount of a harmful protein in people with Huntington's Disease.

Eligible Conditions
  • Huntington Disease

VIBRANT-HD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of treatment emergent adverse events and serious adverse events
Reduction (%) of mHTT protein in cerebrospinal fluid (CSF)
Secondary outcome measures
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

VIBRANT-HD 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
2,855 Previous Clinical Trials
4,197,361 Total Patients Enrolled
1 Trials studying Huntington Disease
44 Patients Enrolled for Huntington Disease

Media Library

Huntington Disease Research Study Groups: Treatment Arm A, Treatment Arm B, Treatment Arm C or X or Y, Placebo
Huntington Disease Clinical Trial 2023: Branaplam Highlights & Side Effects. Trial Name: NCT05111249 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there long-term repercussions to prescription Branaplam?

"While Phase 2 trials don't have data supporting efficacy, Branaplam's safety was supported by enough evidence to give it a score of 2."

Answered by AI

What makes this clinical trial unique?

"At the moment, there are 2 ongoing trials for Branaplam in 10 cities and 13 countries. The first trial was conducted in 2015 by Novartis Pharmaceuticals. 40 patients participated in Phase 1 & 2 of the study with the goal of drug approval. Since then, 18290 similar studies have been completed."

Answered by AI

Can octogenarians participate in this test?

"According to this trial's eligibility requirements, participants must be aged 25-75. There are 3 other trials ongoing for people who fall outside of that age range (under 18 and over 65 respectively)."

Answered by AI

Which patients would be a good match for this research?

"This clinical trial is enrolling 75 participants with huntington disease between the ages of 25 and 75. Most notable, patients are required to meet the following criteria: Clinically diagnosed Stage 1 or 2 Huntington's disease with a diagnostic confidence level (DCL) = 4 and a United Huntington's Disease Rating Scale (UHDRS) Total Functional Capacity (TFC) >8 at screening., Signed informed consent must be obtained prior to participation in the study., Genetically confirmed Huntington's disease, with presence of ≥40 cytosine-adenineguanine (CAG) repeats in the huntingtin gene., Male and female"

Answered by AI

What primary goals does this experiment hope to answer?

"The primary outcome of this study is the number of treatment emergent adverse events and serious adverse events, which will be evaluated over a Baseline up to Week 17 time frame. Secondary outcomes include the concentration ratio of UFB112 in CSF/plasma, which is defined as the concentration ratio will be calculated by measuring UFB112 in CSF samples collected via lumbar puncture and blood samples; the area under the curve (AUC) of UFB112 in plasma, which is defined as AUC will be calculated by measuring concentrations of UFB112 in blood samples; and the time taken to reach Cmx"

Answered by AI

What is the research history of Branaplam?

"The first clinical trial for branaplam was conducted in 2015 by Novartis. Since that time, a total of 18290 trials have been completed. Right now, there are 2 ongoing studies recruiting patients; both based in New york City."

Answered by AI

What is the total sample size for this research project?

"This study is no longer looking for new patients to enroll. It was originally posted on December 8th, 2021 but has not been updated since September 1st, 2022. For other trials, 37 are actively recruiting patients with huntington disease and 2 are recruiting participants for Branaplam."

Answered by AI

Does this research project have a large footprint in our state?

"Right now, this clinical study is enrolling patients at 6 locations. These sites are in New york, Philadelphia and Montreal as well cities. If you want to take part in this research, try to select the closest location to reduce travel time."

Answered by AI

Are there any available slots for volunteers in this clinical trial?

"This study is not taking on any more participants at the moment. According to information found on clinicaltrials.gov, this trial was first posted on December 8th, 2021 and updated September 1st, 2022. There are 37 other trials for Huntington disease and 2 trials for Branaplam that are still recruiting patients."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
~8 spots leftby Apr 2025