Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis

NCT ID: NCT00069186

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2005-04-30

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).

Detailed Description

Introduction: Twenty-one ALS patients were enrolled in a placebo controlled pilot study at the Carolinas Neuromuscular/ALS-MDA Center, The University of Texas Health Science Center at San Antonio and The University of New Mexico at Albuquerque. At all time points sampled over a nine month period, patients taking creatine monohydrate had either a significantly greater improvement in their strength or a more modest decline compared to the patients taking placebo. Overall analysis of variance is significant for both an effect of the drug (p=0.002) and time (p< 0.001).The pilot study also showed that quality of life, as measured by ALSFRS-R, correlated significantly with the observed changes in muscle strength (MVIC).

Phase III Study: The primary objective of this study is to determine whether treatment with creatine monohydrate results in an increase in muscle strength relative to placebo in patients with amyotrophic lateral sclerosis (ALS), after three months, and at the end of a nine-month treatment period.

The study is a Phase III, eight-center, double-blind, placebo-controlled, randomized clinical trial designed to evaluate the safety and efficacy of creatine monohydrate in patients fulfilling the eligibility criteria. The subjects (n=156) will be randomized in a 1:1 ratio to receive treatment of highly purified creatine monohydrate or placebo (Dextrose, USP) for nine months. The subjects will be administered 10 grams of creatine monohydrate per day for the first five days, and then 5 grams per day thereafter. Each subject will be followed for the nine-month treatment period.

The primary outcome measure for the study is change in upper extremity motor function after three weeks, and at the end of a nine-month treatment period as tested by MVIC. Strength in ten arm muscles will be measured (bilateral shoulder and elbow flexion/extension and grip).

Patient safety will be assured by ongoing review of reports of adverse events, clinical laboratory data, and measurement of vital signs. These tests include: measurement of MVIC and muscle fatigue, measurement of FVC, completion of ALSFRS-R and SF-12 quality of life instruments, review of potential adverse effects, determination of vital signs and weight, serum creatinine and BUN, and urine dipstick for protein.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Creatine Monohydrate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Avicena Group

INDUSTRY

Sponsor Role: lead

Principal Investigators

Rosenfeld Jeffrey, MD

Role: PRINCIPAL_INVESTIGATOR

Carolinas ALS Center

Locations

University of California, San Francisco

San Francisco, California, United States

University of Kansas

Kansas City, Kansas, United States

University of New Mexico

Albuquerque, New Mexico, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Oregon Health Sciences University

Portland, Oregon, United States

University of Texas Health Science Center

San Antonio, Texas, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

Orphan Drug:01-1527

Identifier Type: -

Identifier Source: secondary_id

AGI-ALS-III-01

Identifier Type: -

Identifier Source: org_study_id