L-citrulline and Metformin in Duchenne's Muscular Dystrophy

Last updated: April 17, 2018
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01995032
DMD02
  • Ages 78-10
  • All Genders

Study Summary

The purpose of the study is to show that the intake of L-citrulline and metformin improves muscle function and delay of progression in patients with Duchenne's muscular dystrophy.

Eligibility Criteria

Inclusion

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

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 functionaccording to discretion of investigator

  • start of cortisone treatment or change in dosage <6 months prior to screening

Study Design

Total Participants: 47
Study Start date:
October 01, 2013
Estimated Completion Date:
March 31, 2016

Study Description

This is a single center, randomized, double-blind, placebo controlled study. The study medication consists of L-citrulline and metformin, respectively placebo given orally; 2.5 g L-citrulline or placebo will be given 3 times daily, metformin containing 250 mg or placebo will be administered 3 times daily. The duration of the study is 26 weeks and comprehends one screening and three study visits.

Amendment 1: Amended eligibility criteria

Connect with a study center

  • University Children's Hospital

    Basel, BS 4031
    Switzerland

    Site Not Available

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