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Histone Deacetylase Inhibitor

Givinostat for Duchenne Muscular Dystrophy

Phase 2 & 3

Waitlist Available

Research Sponsored by Italfarmaco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial is testing the long-term effects of a drug called Givinostat in people with Duchenne's Muscular Dystrophy.

Who is the study for?

This trial is for boys aged ≥6 with Duchenne Muscular Dystrophy who've been in a previous Givinostat study. They must have specific muscle fat levels, be able to consent, and use contraception if needed. Excluded are those with hypersensitivity to the drug's components, certain intolerances or diseases, heart failure, liver issues, psychiatric conditions affecting compliance, recent non-steroid muscle treatments, other neurological disorders or abnormal blood tests.Check my eligibility

What is being tested?

The trial is testing the long-term safety and effectiveness of Givinostat in patients with Duchenne Muscular Dystrophy. It's an open-label study meaning everyone knows they're getting Givinostat and it focuses on those who've previously taken part in related studies.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions similar to any known allergies to ingredients in Givinostat. Patients should also monitor for signs of liver impairment or digestive issues due to sorbitol intolerance mentioned as exclusion criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Side effects data

From 2017 Phase 1 & 2 trial • 48 Patients • NCT01901432

67%

Diarrhoea

67%

Dysgeusia

33%

Haemorrhoids

33%

Asthenia

33%

Blood creatinine increased

33%

Abdominal pain

33%

Flatulence

33%

Fatigue

33%

Electrocardiogram qt prolonged

33%

Hyperglycaemia

33%

Hyperkalaemia

33%

Alopecia

33%

Myocardial infarction

33%

Chromaturia

33%

Chronic kidney disease

33%

Flushing

100%

80%

60%

40%

20%

Study treatment Arm

Givinostat DL6 (100 mg + 50 mg) (Part A)

Givinostat at MTD (100 mg b.i.d.) (Part B)

Givinostat DL0 (50 mg b.i.d.) (Part A)

Givinostat DL1 (100 mg b.i.d.) (Part A)

Givinostat DL1 Expanded (100 mg b.i.d.) (Part A)

Trial Design

1Treatment groups

Experimental Treatment

Group I: givinostatExperimental Treatment1 Intervention

Givinostat oral suspension (10 mg/mL) twice daily in a fed state

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Givinostat

2013

Completed Phase 2

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

CromsourceIndustry Sponsor

17 Previous Clinical Trials

3,011 Total Patients Enrolled

ItalfarmacoLead Sponsor

33 Previous Clinical Trials

4,293 Total Patients Enrolled

Media Library

Givinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03373968 — Phase 2 & 3

Duchenne Muscular Dystrophy Research Study Groups: givinostat

Duchenne Muscular Dystrophy Clinical Trial 2023: Givinostat Highlights & Side Effects. Trial Name: NCT03373968 — Phase 2 & 3

Givinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03373968 — Phase 2 & 3

Frequently Asked Questions

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

How large is the sample size for this research?

"This study isn't enrolling new patients at this time. However, if you're looking for other trials, 88 clinical studies are admitting patients with muscular dystrophy and Duchenne. Additionally, there are two Givinostat studies that are actively recruiting patients."

Answered by AI

Are there other published papers on the efficacy of Givinostat?

"There are two active clinical trials for Givinostat, one of which is in Phase 3. 54 different research centres across the world are testing this treatment, with most located in Berlin, BA."

Answered by AI

In how many different medical clinics is this study being run today?

"Enrollment for this clinical trial is currently happening at Rady Children's Hospital center - UCSD Department of Neuroscience in San Diego, Missouri, Washington University School of Medicine in St Louis Department of Neurology 660 S.Euclid Avenue, Campus Box 8111 in Saint Louis, British Columbia, The University of British Columbia, Children's and Womens Health Centre of BC Branch in Vancouver, Connecticut as well as 13 other locations."

Answered by AI

Has this kind of clinical trial been done before?

"Givinostat has undergone clinical trials since 2013. The first study, sponsored by Italfarmaco, took place in that same year. Following the initial 90-person trial, Givinostat received approval for Phase 2 testing. Now, there are two active studies involving this medication taking place across 23 cities and 11 countries."

Answered by AI

Is this experiment still looking for new test subjects?

"This particular trial is not actively looking for recruits at this time, as reflected on clinicaltrials.gov. The study was initially posted on 10/24/2017 and updated as recently as 3/3/2022. However, there are other trials with similar eligibility criteria that are currently recruiting patients."

Answered by AI