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Nusinersen for Spinal Muscular Atrophy (ONWARD Trial)
ONWARD Trial Summary
This trial is for participants with Spinal Muscular Atrophy who have previously participated in another study. They will be given nusinersen, which is a drug meant to help with the disease. The study is to see if the drug is safe and effective long-term.
ONWARD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowONWARD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 3 trial • 126 Patients • NCT02292537ONWARD Trial Design
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Who is running the clinical trial?
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- You have already finished a specific study visit on Day 302 as part of a previous study (NCT04089566).Please provide more details for an accurate summary.You have been treated with approved medication for spinal muscular atrophy after a certain study visit.
- Group 1: BIIB058 28 mg (Prior Maintenance Dose 28 mg)
- Group 2: BIIB058 50/28 mg (Prior Maintenance Dose 12 mg)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Where can patients find this trial?
"Currently, this clinical trial is being run out of 7 sites. The locations include London, Baltimore, Sacramento, and 7 other sites. To minimize travel demands, patients are encouraged to enroll at the site nearest them."
Does this experiment still have room for more test subjects?
"This clinical trial is not presently looking for new participants. The trial was first posted on 4/19/2021 and was most recently updated on 10/21/2022. If you are exploring other studies, there are presently 205 studies actively admitting patients with muscular atrophy, spinal and 7 studies for Nusinersen actively enrolling participants."
Is Nusinersen a new medical treatment?
"There are 7 ongoing studies involving Nusinersen, 4 of which are in the critical Phase 3. The largest number of research centres are based in Madrid and Washington, but there are a total of 205 locations running trials for this medication."
Will patients experience any harmful side-effects from Nusinersen?
"Nusinersen has received a safety rating of 3 from our team at Power. This is because Nusinersen is in Phase 3 clinical trials, which suggests that there is both efficacy and safety data available."
What is the significance of this clinical trial in the medical world?
"Nusinersen has been under clinical investigation since 2015 when Biogen sponsored its first study. After the Phase 1 clinical trial with 25 patients, Nusinersen was approved for Phase 2 drug trials. To date, there are 7 active Nusinersen trials being conducted in 31 different countries and across 70 cities."
Who else is applying?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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