Duchene Muscular DystrophyPROVIDUSNCT07127978
A Study Evaluating the Real-World Experience of Givinostat in Patients With Duchenne Muscular Dystrophy
An observational study of Duchene Muscular Dystrophy, run by ITF Therapeutics LLC at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Duchene Muscular Dystrophy
- How many people
- 300 participants
- Where
- 9 sitesUnited States
- Study dates
- 23 Oct 2025to 30 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will be conducted in the US and plans to enroll 300 patients diagnosed with DMD and treated with givinostat as part of their routine clinical care. Patients will be recruited from expert centers treating DMD patients with specialists in neuromuscular conditions who are routinely involved in the care and treatment of patients with DMD, some of whom would have already gained experience with givinostat.
Who may be able to join
- 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.
- Patient's index date (first date of givinostat treatment) is no more than 6 months prior to signing of informed consent.
- Patient has the required data available (DMD diagnosis, givinostat administration [dose and schedule], laboratory results [hematology and triglycerides]) for addressing the study objectives for the period between index date and study entry (for patients enrolled after the index date).
Who cannot join
- Patient previously received givinostat (commercial or investigational product) and permanently discontinued treatment or patient started commercial givinostat for > 6 months before signing of informed consent.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Gerald Mastellone, 857-218-4677, Gerald.mastellone@childrens.harvard.edu
Partha Ghosh, MD
- Recruiting
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Raven Hill, 312-227-2937, rhill@luriechildrens.org
Bridget McGowan
- Recruiting
Duke University / Lenox Baker Children's Hospital
Durham, North Carolina, 27705
Brittany Nave, 919-684-8087, brittany.nave@duke.edu
Natalie Katz, MD
- Recruiting
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
Domencia Hunter, 973-932-9211, hunterdj@archildrens.org
Aravindhan Veerapandiyan
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Kimberly Berry, 212-342-3038, kb2996@cumc.columbia.edu
Divya Jayaraman
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Nadee Dayananda, 503-418-0949, dayanand@ohsu.edu
Erika Finanger, MD
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Macarena Racciatti, 206-995-6847, macarena.racciatti@seattlechildrens.org
Alicia Henriquez
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Margaret Martinez, 202-476-2431, mbmartin@childrensnational.org
Sarah Wright, DO
- Recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
Sarah Figueira, (508) 856-1604, sarah.figueira@umassmed.edu
dmdprogram@umassmemorial.org
About this study
Official title: A Prospective, Observational Study Evaluating the Real-World Experience of Givinostat in Patients With Duchenne Muscular Dystrophy
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 of follow-up.
Read the detailed description
Duchenne Muscular Dystrophy (DMD) is a rare genetic disorder that leads to progressive muscle degeneration and weakness. Givinostat, an oral histone deacetylase inhibitor, was approved by the FDA in March 2024 for treatment of DMD in patients aged 6 years and older, regardless of mutation type.
Study participation will not influence the course of treatment in any way (including other treatments for DMD), and no treatment will be provided as part of this study. All assessments are intended to be performed at the time of a routine clinical care visit according to clinical practice, and data will be extracted from the medical records.
The FDA is requiring a post-marketing prospective study be conducted for a minimum of 5 years to characterize the incidence, frequency, and severity of thrombocytopenia and serious events of bleeding in patients with DMD treated with oral givinostat in routine clinical practice.
This study is designed as a prospective, observational study to assess safety (including evaluation of AEs of special interest [AESIs]) and effectiveness, in patients with DMD newly initiating oral givinostat as part of routine clinical care in the US in a real-world population. The study will assess AESIs noted above, as well as serious adverse events (SAEs), gastrointestinal (GI) AEs, and dehydration as a sequela to GI AEs. Real-world-treatment patterns of DMD treatments (corticosteroids, exon skipping oligonucleotides and gene therapy) prior to and after givinostat initiation, including treatment duration, and treatment combinations, will be described. Effectiveness evaluations will characterize motor function, quality of life, and activities of daily living in DMD patients treated with givinostat.
The study will enroll 300 participants (180 non-ambulatory and up to 120 ambulatory patients). Participants will be followed for at least two years, with data collected during routine clinical visits. Assessments include lab parameters (e.g., platelet counts, triglycerides), cardiac and pulmonary function, patient-reported outcomes, and motor function scales such as the North Star Ambulatory Assessment (NSAA) and Performance of Upper Limb (PUL) scale.
- Conditions
- Duchene Muscular Dystrophy
- Keywords
- DMD, DUVYZAT, U.S study, duchenne muscular dystrophy, givinostat, non-interventional study, pediatric neuromuscular disease, rare disease, quality of life, effectiveness, post-marketing requirement, safety, motor function, muscular dystrophy, standard of care, real-world evidence, observational study, post-marketing study
- Medical subject headings
- Muscular Dystrophy, Duchenne, Rare Diseases, Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory | Ambulatory is defined as being able to complete the 10-meter Walk-Run (10mWR) test within 30 seconds without an assistive device. This cohort will include up to 120 patients who are ambulatory prior to starting givinostat treatment. Within this cohort , 95 patients must have had prior use or a referral for concomitant use of dystrophin-enhancing therapy (DET), such as exon skipping oligonucleotides or gene therapy. Enrollment is capped at 25 patients without prior or referred DET use. | |
| Non-Ambulatory | Non-ambulatory status is determined by inability to perform the 10mWR test as defined above. This cohort will include approximately 180 patients who are non-ambulatory prior to starting givinostat. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the incidence of thrombocytopenia / decreased platelet counts in DMD patients treated with oral givinostat
Incidence rate of thrombocytopenia (per 100 patient years of observation time) post index date
Measured: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the frequency of thrombocytopenia / decreased platelet counts in DMD patients treated with oral givinostat
Frequency and incidence proportion (overall and by maximum severity) of thrombocytopenia
Measured: [Time Frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)]
Characterize severity of serious events thrombocytopenia / decreased platelet counts in DMD patients treated with oral givinostat
Time to first thrombocytopenia event from index date
Measured: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the incidence of serious events of bleeding in DMD patients treated with oral givinostat
Incidence rate of serious bleeding events (per 100-patient years of observation time) post index date
Measured: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the frequency of serious events of bleeding in DMD patients treated with oral givinostat
Frequency and incidence proportion (overall and by maximum severity) of serious bleeding events
Measured: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the severity of serious events of bleeding in DMD patients treated with oral givinostat
Time to first serious bleeding event from index date
Measured: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Secondary outcomes (10)
Characterize the incidence of other adverse events of special interest (AESIs) in DMD patients treated with oral givinostat
Incidence rates of each AESI (per 100-patient years of observation time) post index date as well as the incidence proportion of AESIs resulting in dose modifications or givinostat discontinuation
Measured: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the frequency other adverse events of special interest (AESIs) in DMD patients treated with oral givinostat
Frequency and incidence proportion (overall and by maximum severity) of each AESI
Measured: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the severity of other adverse events of special interest (AESIs) in DMD patients treated with oral givinostat
Time to first event of each AESI from index date
Measured: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the incidence of all serious adverse events (SAEs) in DMD patients treated with oral givinostat
Incidence rates of SAEs (per 100-patient years of observation time) post index date by SOC and PT within SOC, and the number of SAEs per patient.
Measured: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the frequency of all serious adverse events (SAEs) in DMD patients treated with oral givinostat
Frequency and incidence proportion (overall and by maximum severity) of SAEs (by system organ class [SOC] and preferred term [PT] within SOC), and the frequency and incidence proportion of SAEs resulting in dose modifications or givinostat discontinuation.
Measured: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the incidence of gastrointestinal (GI) AEs (nausea, vomiting, diarrhea, abdominal pain, constipation) in DMD patients treated with givinostat
Incidence rates of GI AEs (per 100-patient years of observation time) post index date by PT.
Measured: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the frequency of gastrointestinal (GI) AEs (nausea, vomiting, diarrhea, abdominal pain, constipation) in DMD patients treated with givinostat
Frequency and incidence proportion (overall and by severity) of GI AEs (by PT), and frequency and incidence proportion of GI AEs resulting in dose modifications or givinostat discontinuation.
Measured: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the severity of gastrointestinal (GI) AEs (nausea, vomiting, diarrhea, abdominal pain, constipation) in DMD patients treated with givinostat
Number of GI AEs per patient
Measured: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterization of hematology laboratory parameters
Change from baseline hematology laboratory parameters over time
Measured: From baseline through end of study (up to 5 years)
Characterization of triglyceride laboratory parameters
Change from baseline triglyceride laboratory parameters over time
Measured: From baseline through end of study (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start23 Oct 2025
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchene Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ITF Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127978
- Sponsor's protocol ID
- ITF/2357/62
- Other IDs
- 126598, 217865
- Acronym
- PROVIDUS
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study Evaluating the Real-World Experience of Givinostat in Patients With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT07127978
- Acronym / sponsor ID
- PROVIDUS / ITF/2357/62
- Conditions
- Duchene Muscular Dystrophy
- Keywords
- DMD, DUVYZAT, U.S study, duchenne muscular dystrophy, givinostat, non-interventional study, pediatric neuromuscular disease, rare disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- ITF Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 of follow-up.
Detailed description
Duchenne Muscular Dystrophy (DMD) is a rare genetic disorder that leads to progressive muscle degeneration and weakness. Givinostat, an oral histone deacetylase inhibitor, was approved by the FDA in March 2024 for treatment of DMD in patients aged 6 years and older, regardless of mutation type.
Study participation will not influence the course of treatment in any way (including other treatments for DMD), and no treatment will be provided as part of this study. All assessments are intended to be performed at the time of a routine clinical care visit according to clinical practice, and data will be extracted from the medical records.
The FDA is requiring a post-marketing prospective study be conducted for a minimum of 5 years to characterize the incidence, frequency, and severity of thrombocytopenia and serious events of bleeding in patients with DMD treated with oral givinostat in routine clinical practice.
This study is designed as a prospective, observational study to assess safety (including evaluation of AEs of special interest [AESIs]) and effectiveness, in patients with DMD newly initiating oral givinostat as part of routine clinical care in the US in a real-world population. The study will assess AESIs noted above, as well as serious adverse events (SAEs), gastrointestinal (GI) AEs, and dehydration as a sequela to GI AEs. Real-world-treatment patterns of DMD treatments (corticosteroids, exon skipping oligonucleotides and gene therapy) prior to and after givinostat initiation, including treatment duration, and treatment combinations, will be described. Effectiveness evaluations will characterize motor function, quality of life, and activities of daily living in DMD patients treated with givinostat.
The study will enroll 300 participants (180 non-ambulatory and up to 120 ambulatory patients). Participants will be followed for at least two years, with data collected during routine clinical visits. Assessments include lab parameters (e.g., platelet counts, triglycerides), cardiac and pulmonary function, patient-reported outcomes, and motor function scales such as the North Star Ambulatory Assessment (NSAA) and Performance of Upper Limb (PUL) scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulatory | – | –Ambulatory is defined as being able to complete the 10-meter Walk-Run (10mWR) test within 30 seconds without an assistive device. This cohort will include up to 120 patients who are ambulatory prior to starting givinostat treatment. Within this cohort , 95 patients must have had prior use or a referral for concomitant use of dystrophin-enhancing therapy (DET), such as exon skipping oligonucleotides or gene therapy. Enrollment is capped at 25 patients without prior or referred DET use. |
| Non-Ambulatory | – | –Non-ambulatory status is determined by inability to perform the 10mWR test as defined above. This cohort will include approximately 180 patients who are non-ambulatory prior to starting givinostat. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be conducted in the US and plans to enroll 300 patients diagnosed with DMD and treated with givinostat as part of their routine clinical care. Patients will be recruited from expert centers treating DMD patients with specialists in neuromuscular conditions who are routinely involved in the care and treatment of patients with DMD, some of whom would have already gained experience with givinostat.
Key inclusion criteria (4 listed)
- 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.
- Patient's index date (first date of givinostat treatment) is no more than 6 months prior to signing of informed consent.
- Patient has the required data available (DMD diagnosis, givinostat administration [dose and schedule], laboratory results [hematology and triglycerides]) for addressing the study objectives for the period between index date and study entry (for patients enrolled after the index date).
Key exclusion criteria (1 listed)
- Patient previously received givinostat (commercial or investigational product) and permanently discontinued treatment or patient started commercial givinostat for > 6 months before signing of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterize the incidence of thrombocytopenia / decreased platelet counts in DMD patients treated with oral givinostat
Time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Incidence rate of thrombocytopenia (per 100 patient years of observation time) post index date
Characterize the frequency of thrombocytopenia / decreased platelet counts in DMD patients treated with oral givinostat
Time frame: [Time Frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)]
Frequency and incidence proportion (overall and by maximum severity) of thrombocytopenia
Characterize severity of serious events thrombocytopenia / decreased platelet counts in DMD patients treated with oral givinostat
Time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Time to first thrombocytopenia event from index date
Characterize the incidence of serious events of bleeding in DMD patients treated with oral givinostat
Time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Incidence rate of serious bleeding events (per 100-patient years of observation time) post index date
Characterize the frequency of serious events of bleeding in DMD patients treated with oral givinostat
Time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Frequency and incidence proportion (overall and by maximum severity) of serious bleeding events
Characterize the severity of serious events of bleeding in DMD patients treated with oral givinostat
Time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Time to first serious bleeding event from index date
10 secondary outcomes
Characterize the incidence of other adverse events of special interest (AESIs) in DMD patients treated with oral givinostat
Time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the frequency other adverse events of special interest (AESIs) in DMD patients treated with oral givinostat
Time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the severity of other adverse events of special interest (AESIs) in DMD patients treated with oral givinostat
Time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the incidence of all serious adverse events (SAEs) in DMD patients treated with oral givinostat
Time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the frequency of all serious adverse events (SAEs) in DMD patients treated with oral givinostat
Time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the incidence of gastrointestinal (GI) AEs (nausea, vomiting, diarrhea, abdominal pain, constipation) in DMD patients treated with givinostat
Time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the frequency of gastrointestinal (GI) AEs (nausea, vomiting, diarrhea, abdominal pain, constipation) in DMD patients treated with givinostat
Time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterize the severity of gastrointestinal (GI) AEs (nausea, vomiting, diarrhea, abdominal pain, constipation) in DMD patients treated with givinostat
Time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)
Characterization of hematology laboratory parameters
Time frame: From baseline through end of study (up to 5 years)
Characterization of triglyceride laboratory parameters
Time frame: From baseline through end of study (up to 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arkansas Children's Research Institute
Little Rock, United States
Children's National Hospital
Washington D.C., United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, United States
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duchene Muscular Dystrophy, run by ITF Therapeutics LLC at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the incidence of thrombocytopenia / decreased platelet counts in DMD patients treated with oral givinostat (time frame: From follow up (after first date of givinostat treatment) through end of study (up to 5 years)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.