NCT00016653

Brief Summary

This study will help to determine the effectiveness of glutamine and creatine as a possible therapy for DMD. Boys with DMD who are enrolled in this trial will be randomly chosen to receive creatine monohydrate or glutamine or an inactive placebo orally for six months. Once a month during the six-month treatment period, the study participants will have their muscle strength evaluated using manual and computerized testing methods. This study will be conducted at several CINRG Centers throughout the U.S., Belgium, Israel and Puerto Rico. This study is supported by the Muscular Dystrophy Association.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2001

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 27, 2011

Status Verified

October 1, 2011

First QC Date

May 21, 2001

Last Update Submit

October 26, 2011

Conditions

Muscular Dystrophy, Duchenne

Keywords

Duchennemusculardystrophytreatment

Interventions

Creatine MonohydrateDRUG
GlutamineDRUG

Eligibility Criteria

Age5 Years - 9 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 5 - 9 years old
  • Able to walk without assistance
  • Diagnosis of DMD confirmed by one of the following:
  • a) Positive X-linked family history; or
  • b) Dystrophin immunofluorescence and/or immunoblot, which shows complete dystrophin deficiency, and clinical picture consistent with DMD; or
  • c) Gene deletion test positive in the central rod domain (exons 25 - 60) of dystrophin, where reading frame can be predicted as 'out-of-frame', and clinical picture consistent with DMD.
  • Glucocorticosteroid-naive (i.e. has not been treated with prednisone or deflazacort within 1 year before the study began), or has been involved in other therapeutic research protocol within the last year
  • Forced Vital Capacity (a lung function test) \> 50% of predicted value
  • Evidence of muscle weakness by MRC score or clinical functional evaluation
  • MRC (manual muscle test) score variability no greater than 10% between screening visits 1 and 2

You may not qualify if:

  • Failure to achieve any of the criteria listed above
  • Symptomatic DMD carrier
  • Symptomatic cardiomyopathy or ventricular arrhythmias
  • Previous (6 months or less) or current use of glutamine or creatine (for DMD or any other indication)
  • Use of carnitine, other amino acids, coenzyme Q10, or any herbal medicines within the last month
  • History of significant concomitant illness or significant impairment of renal or hepatic function
  • Evidence of allergy to chocolate or milk solids (substances will be delivered in a powdered hot cocoa mixture)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

  • Escolar DM, Buyse G, Henricson E, Leshner R, Florence J, Mayhew J, Tesi-Rocha C, Gorni K, Pasquali L, Patel KM, McCarter R, Huang J, Mayhew T, Bertorini T, Carlo J, Connolly AM, Clemens PR, Goemans N, Iannaccone ST, Igarashi M, Nevo Y, Pestronk A, Subramony SH, Vedanarayanan VV, Wessel H; CINRG Group. CINRG randomized controlled trial of creatine and glutamine in Duchenne muscular dystrophy. Ann Neurol. 2005 Jul;58(1):151-5. doi: 10.1002/ana.20523.

    PMID: 15984021RESULT

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Interventions

CreatineGlutamine

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, BasicAmino Acids, DiaminoAmino Acids, Neutral

Study Officials

  • Diana M Escolar, MD

    Cooperative International Neuromuscular Research Group

    STUDY DIRECTOR

  • Gunnar Buyse, MD, PhD

    Cooperative International Neuromuscular Research Group

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 21, 2001

First Posted

May 23, 2001

Study Start

June 1, 2000

Study Completion

December 1, 2006

Last Updated

October 27, 2011

Record last verified: 2011-10

Locations

US(1)