MedTrace Logo

Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old

NCT06769633 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-07-10

No results posted yet for this study

Summary

This is a Phase 2 Open-label (Core Phase Plus Extension Phase) With 2 Cohorts Study to Assess the Pharmacokinetics and Safety of Givinostat in younger DMD Patients.

* Planned screening duration: approximately 4 weeks
* Planned Core Treatment duration: approximately 48 weeks
* Planned Extension Treatment duration: approximately 96 weeks
* Planned Follow Up duration: approximately 4 weeks (± 7 days)
* Total duration of study participation: up to 151 weeks (ie, 37-38 months)

Conditions

Interventions

DRUG

Givinostat Hydrochloride

Cohort 1 - from 4 to 6 years old

DRUG

Givinostat Hydrochloride - Cohort 2

Cohort 2 - from 2 to 4 years old

Sponsors & Collaborators

  • Fortrea

    collaborator INDUSTRY

  • Italfarmaco

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • Belgium
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06769633 on ClinicalTrials.gov