Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis

NCT00069186 | Unknown Phase 3

• 2 other identifiers: AGI-ALS-III-01Orphan Drug:01-1527
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to determine whether nine months of administration of creatine monohydrate results in an increase in muscle strength in patients with amyotrophic lateral sclerosis (ALS).

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

Amyotrophic Lateral Sclerosis; ALS; Creatine; Creatine Monohydrate; Muscle Strength

Outcome Measures

Primary Outcomes (2)

• Change in upper extremity motor function after 3 weeks

• Change in upper extremity motor function after 9 months

Secondary Outcomes (6)

• Acute changes in muscle strength

• Chronic changes in muscle strength

• ALS functioning

• Quality of life

• Pulmonary function

Interventions

Creatine Monohydrate DRUG

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* A clinical diagnosis of probable or definite lab-supported ALS, either SALS or FALS, according to modified El Escorial criteria. * Males or females, 21 to 80 years of age. * Patients receiving treatment with Rilutek® (riluzole) must be on a stable dose for at least 30 days immediately prior to enrollment. * Women of childbearing potential must be non-lactating and surgically sterile or using an effective method of birth control (double barrier or oral contraception) and have a negative pregnancy test. Women will be considered menopausal if they have not had a menstrual cycle (period) for two years. * Disease duration less than five years since symptom onset. * At least 5 of 10 testable upper extremity muscle groups of MRC grade 4 or better. * The patient must have given informed consent that has been approved by the appropriate Institutional Review Board (IRB).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Avicena Group: lead

Study Sites (8)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203-5812, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 48284-7883, 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 Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Rosenfeld Jeffrey, MD

  Carolinas ALS Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2003
• First Posted: September 23, 2003
• Study Start: June 1, 2003
• Study Completion: April 1, 2005
• Last Updated: June 24, 2005

Record last verified: 2005-04

Locations

US (8)