Givinostat for Duchenne Muscular Dystrophy
A Study Evaluating the Real-World Experience of Givinostat in Patients With Duchenne Muscular Dystrophy
Recruiting
Observational Study
Duchene Muscular Dystrophy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 6 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 300 (estimated)
- Sponsor
- ITF Therapeutics LLC · Industry
Who this trial is looking for
This trial is looking for patients with Duchenne Muscular Dystrophy (DMD) who are starting treatment with givinostat or have recently begun it. Participants will be monitored for their safety and how well the treatment works over time.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 6 years old.
- I have been diagnosed with Duchenne Muscular Dystrophy.
- I have received a prescription for the medication givinostat.
- I have given my consent to participate.
- I started taking givinostat no more than 6 months before consenting.
- I have the necessary health data available for the study.
You may not be able to join if
- I have previously received givinostat and stopped it permanently.
- I started taking commercial givinostat more than 6 months before consenting.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
This is a prospective observational study conducted to evaluate safety, tolerability, and functional outcomes of patients with DMD newly initiating oral givinostat or having started therapy within 6 months as part of routine clinical care in the US. The study has a planned maximum duration of 5 years for the first enrolled patients, including a 24-month enrollment period and a minimum of 2 years o…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients of any gender at least 6 years of age, diagnosed with DMD (according to genetic test) and have received a prescription for oral givinostat in accordance with the USPI.
* Patient has provided informed consent (and assent when applicable) for participation in the study.…
Contacts
No contact information available.