NCT00070993

Brief Summary

Creatine is a naturally occurring chemical involved in the production of energy in muscle. Abnormalities in creatine have been linked to the progression of degenerative neuromuscular diseases such as amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). This study will test whether taking creatine can improve the symptoms of ALS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2002

Typical duration for phase_2

Geographic Reach
1 country

6 active sites

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

December 1, 2002

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2003

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

August 4, 2006

Status Verified

August 1, 2006

First QC Date

October 9, 2003

Last Update Submit

August 3, 2006

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALSCreatine

Interventions

creatine monohydrateDRUG

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of probable or definite ALS
  • At least 5 of 10 testable upper extremity muscle groups (shoulder and elbow extensors/flexors and grip) of Medical Research Council (MRC) grade 4 or better
  • At least 5 years from onset of symptoms

You may not qualify if:

  • Requires tracheostomy ventilation
  • History of renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Rush-Presbyterian St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of New Mexico - Medical Center

Albuquerque, New Mexico, 87131, United States

Location

University of Texas Health and Science Center

San Antonio, Texas, 78284, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Creatine

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Jeffrey Rosenfeld, MD

    Carolinas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 9, 2003

First Posted

October 13, 2003

Study Start

December 1, 2002

Study Completion

May 1, 2006

Last Updated

August 4, 2006

Record last verified: 2006-08

Locations

US(6)