Your session is about to expire
← Back to Search
Part A: Cohort 4: BIIB115 Dose 4 for Spinal Muscular Atrophy
Study Summary
This trial aims to test the safety and tolerability of a new drug called BIIB115 given as a single dose to healthy male participants and as multiple doses to pediatric patients with Spinal Muscular At
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Frequently Asked Questions
Are there a substantial number of medical facilities in the United States that are currently conducting this clinical trial?
"Twelve active sites, including Universitair Ziekenhuis Gent in Gent, Universitaetsklinikum Heidelberg in Heidelberg, and Centre For Human Drug Research in Leiden are currently enrolling participants. Additionally, there are a dozen other locations participating in this trial."
Are there any vacancies available for patients to participate in this trial?
"Indeed, data available on clinicaltrials.gov indicates the ongoing recruitment of participants for this trial. The study was first posted on October 10th, 2022 and most recently updated on March 12th, 2024. There is a need to enlist 62 individuals from among the twelve participating sites."
Is this research trial enrolling individuals older than 40 years?
"To be considered for this study, participants must range from 6 months to 55 years of age."
What is the current number of individuals actively participating in this research endeavor?
"Indeed, data available on clinicaltrials.gov highlights the ongoing recruitment of participants for this investigation. The trial was posted online on October 10th, 2022 and most recently updated on March 12th, 2024. A total of 62 individuals are sought from a network spanning across 12 different sites."
What are the criteria for individuals who may qualify to participate in this research?
"This study aims to enroll 62 individuals diagnosed with spinal muscular atrophy, aged between 6 months and 55 years. Eligible participants must meet specific criteria including a minimum weight of ≥7 kg at the time of consent, having a Survival Motor Neuron 2 (SMN2) copy number of ≥1, receiving treatment with onasemnogene abeparvovec for at least 180 days before their first dose of BIIB115, showing potential for improvement due to suboptimal clinical status linked to SMA as determined by the Investigator Key assessment, possessing a genetic diagnosis involving SMN1 gene deletion or mutation"
Has Part A: Cohort 4 involving BIIB115 Dose 4 been granted approval by the Food and Drug Administration?
"Based on the phase of this trial, our assessment at Power indicates a safety rating of 1 for Part A: Cohort 4 involving BIIB115 Dose 4. This score reflects the preliminary nature of available data regarding its safety and effectiveness."
Share this study with friends
Copy Link
Messenger