Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Amyotrophic Lateral Sclerosis (ALS)	Drug: Creatine Monohydrate	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	107 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Phase III, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis
Study Start Date :	June 2003
Study Completion Date :	April 2005

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change in upper extremity motor function after 3 weeks
2. Change in upper extremity motor function after 9 months

Secondary Outcome Measures :

1. Acute changes in muscle strength
2. Chronic changes in muscle strength
3. ALS functioning
4. Quality of life
5. Pulmonary function
6. Muscle fatigue.

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

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Locations

United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Kansas
University of Kansas
Kansas City, Kansas, United States, 66160
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203-5812
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 48284-7883
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

The Avicena Group

Investigators

Principal Investigator:	Rosenfeld Jeffrey, MD	Carolinas ALS Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00069186 History of Changes
Other Study ID Numbers:	AGI-ALS-III-01; Orphan Drug:01-1527
First Posted:	September 23, 2003
Last Update Posted:	June 24, 2005
Last Verified:	April 2005

Keywords provided by The Avicena Group:

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

Additional relevant MeSH terms:

Sclerosis; Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Pathologic Processes; Neurodegenerative Diseases; Nervous System Diseases	Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases