Duchenne Muscular DystrophyPhase 3NEBIDYSNCT01648634
Nebivolol for the Prevention of Left Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy
A Phase 3 study testing Nebivolol in people with Duchenne Muscular Dystrophy and Cardiomyopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objective is to determine whether nebivolol, a beta-blockade drug, can prevent the development of heart disease in patients with Duchenne muscular dystrophy aged 10 to 15 year-old. Read more about this study
- Who is it for?
- Ages 10 to 15 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy, Cardiomyopathy, Heart Failure
- What is being tested?
- Nebivolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2012to 20 Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 10 to 15 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Duchenne muscular dystrophy genetically proven
- Age between 10 and 15 years
- Left ventricular ejection fraction assessed by radionuclide angiography or echocardiography ≥50% and measured within 3 months
- Systolic blood pressure ≥80 mmHg
- Diastolic blood pressure ≥70 mmHg
Who cannot join
- Heart rate <50 bpm
- 2nd or 3rd degree atrioventricular blocks, sinus node dysfunction
- Asthma or bronchospasm
- Severe peripheral circulatory disease
- Hypersensitivity to nebivolol or excipients
- Metabolic acidosis
Show all 11Show fewer
- Blood urea >7 mmol/l
- Liver transaminases enzymes >6 fold the upper limit of normal
- Formal indication for beta-blockade treatment
- Cardiac treatments except angiotensin-converting enzyme inhibitors
- Participation to another clinical trial within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Examine the Effect of Nebivolol, a Beta-Blockade Drug, for the Prevention of Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy
The objective is to determine whether nebivolol, a beta-blockade drug, can prevent the development of heart disease in patients with Duchenne muscular dystrophy aged 10 to 15 year-old.
Read the detailed description
A 1.25 mg-test dose will be administrated to assess the treatment tolerance before randomization. A forced titration of nebivolol and placebo will be performed with 2 weeks periods. Full dose of nebivolol and placebo is 5mg/day (7.5mg/day for patients whose weight is>60kg).
- Conditions
- Duchenne Muscular Dystrophy, Cardiomyopathy, Heart Failure
- Being tested
- Nebivolol, Placebo
- Keywords
- Nebivolol, beta-blockade treatment
- Medical subject headings
- Muscular Dystrophy, Duchenne, Cardiomyopathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebivololDrug
A 1.25mg-test dose will be administrated to assess the treatment tolerance before randomization. A forced titration of nebivolol will be performed with 2 weeks periods. Full dose of nebivolol is 5mg/day (7.5mg/day for patients whose weight is>60kg)
PlaceboDrug
A 1.25mg-test dose of nebivolol will be administrated to assess the treatment tolerance before randomization. A forced titration of placebo will be performed with 2 weeks periods. Full dose of placebo is 5mg/day (7.5mg/day for patients whose weight is>60kg)
| Study group | Role | What they receive |
|---|---|---|
| Nebivolol | Experimental | Not described Receives: Drug: Nebivolol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular systolic dysfunction
Development of left ventricular systolic dysfunction with an ejection fraction < 45%
Measured: at 5 years
Secondary outcomes (5)
Right ventricular ejection fraction
Right ventricular ejection fraction assessed by radionuclide angiography or echocardiography
Measured: at 5 years
NT-ProBNP
NT-ProBNP
Measured: at 1, 2, 3, 4, and 5 years
Left ventricular dysfunction
Development of left ventricular dysfunction
Measured: at 10 years
Hospitalizations
hospitalizations for heart failure
Measured: at 10 years
Mortality
Cardiovascular mortality
Measured: at 10 years ((5-years open label extension)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study start13 Feb 2012
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Henri-Marc BECANE, MD,PhD, Principal investigator, Armand Trousseau Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648634
- Sponsor's protocol ID
- P090202
- Other IDs
- 2010-020047-12
- Acronym
- NEBIDYS
- Status last verified
- Oct 2025
- First submitted
- 20 Jul 2012
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Examine the Effect of Nebivolol, a Beta-Blockade Drug, for the Prevention of Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT01648634
- Acronym / sponsor ID
- NEBIDYS / P090202
- Conditions
- Duchenne Muscular Dystrophy, Cardiomyopathy, Heart Failure
- Keywords
- Nebivolol, beta-blockade treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris, URC-CIC Paris Descartes Necker Cochin
- Study start
- 13 Feb 2012 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 24 Jul 2012 (estimated)
- 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.
The objective is to determine whether nebivolol, a beta-blockade drug, can prevent the development of heart disease in patients with Duchenne muscular dystrophy aged 10 to 15 year-old.
Detailed description
A 1.25 mg-test dose will be administrated to assess the treatment tolerance before randomization. A forced titration of nebivolol and placebo will be performed with 2 weeks periods. Full dose of nebivolol and placebo is 5mg/day (7.5mg/day for patients whose weight is>60kg).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebivolol | Experimental | Drug: Nebivolol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Duchenne muscular dystrophy genetically proven
- Age between 10 and 15 years
- Left ventricular ejection fraction assessed by radionuclide angiography or echocardiography ≥50% and measured within 3 months
- Systolic blood pressure ≥80 mmHg
- Diastolic blood pressure ≥70 mmHg
Key exclusion criteria (11 listed)
- Heart rate <50 bpm
- 2nd or 3rd degree atrioventricular blocks, sinus node dysfunction
- Asthma or bronchospasm
- Severe peripheral circulatory disease
- Hypersensitivity to nebivolol or excipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NebivololA 1.25mg-test dose will be administrated to assess the treatment tolerance before randomization. A forced titration of nebivolol will be performed with 2 weeks periods. Full dose of nebivolol is 5mg/day (7.5mg/day for patients whose weight is>60kg) | Drug | Nebivolol |
| PlaceboA 1.25mg-test dose of nebivolol will be administrated to assess the treatment tolerance before randomization. A forced titration of placebo will be performed with 2 weeks periods. Full dose of placebo is 5mg/day (7.5mg/day for patients whose weight is>60kg) | Drug | Placebo |
Primary outcome
Left ventricular systolic dysfunction
Time frame: at 5 years
Development of left ventricular systolic dysfunction with an ejection fraction < 45%
5 secondary outcomes
Right ventricular ejection fraction
Time frame: at 5 years
NT-ProBNP
Time frame: at 1, 2, 3, 4, and 5 years
Left ventricular dysfunction
Time frame: at 10 years
Hospitalizations
Time frame: at 10 years
Mortality
Time frame: at 10 years ((5-years open label extension)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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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. This study is not recruiting at the moment.
Henri-Marc BECANE, MD,PhD principal investigator
Armand Trousseau Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nebivolol in people with Duchenne Muscular Dystrophy and Cardiomyopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular systolic dysfunction (time frame: at 5 years). 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 20 Nov 2025.