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Branaplam for Huntington Disease (VIBRANT-HD Trial)
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.
- Huntington Disease
VIBRANT-HD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VIBRANT-HD Trial Design
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Who is running the clinical trial?
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- Group 1: Treatment Arm A
- Group 2: Treatment Arm B
- Group 3: Treatment Arm C or X or Y
- Group 4: Placebo
Frequently Asked Questions
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."
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."
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)."
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"
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"
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."
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."
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."
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."
Who else is applying?
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What site did they apply to?
What portion of applicants met pre-screening criteria?
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