Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT01995032
Eligibility Criteria:
Inclusion Criteria:
* Molecular diagnosis of DMD
* Patients 6.5 - 10 years of age at time of screening
* Ambulant
* Ability to walk 150 m in the 6 min walking distance (6MWT)
* D1 subdomain of the MFM scale \>40%
* stable treatment with steroids for \>6 months or steroid naïve patients
Exclusion Criteria:
* Previous (3 months or less) or concomitant participation in another therapeutic trial
* Use of L-citrulline, L-arginine or metformin within the last 3 months
* Known individual hypersensitivity to L-citrulline or metformin
* known or suspected malignancy
* Other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of investigator
* start of cortisone treatment or change in dosage \<6 months prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
78 Months
Maximum Age:
10 Years
Study:
NCT01995032
Study Brief:
Protocol Section:
NCT01995032