Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis

June 23, 2005 updated by: The Avicena Group

A Phase III, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

107

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in upper extremity motor function after 3 weeks
Change in upper extremity motor function after 9 months

Secondary Outcome Measures

Outcome Measure
Quality of life
Pulmonary function
Acute changes in muscle strength
Chronic changes in muscle strength
ALS functioning
Muscle fatigue.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Avicena Group

Investigators

  • Principal Investigator: Rosenfeld Jeffrey, MD, Carolinas ALS Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

September 17, 2003

First Submitted That Met QC Criteria

September 22, 2003

First Posted (ESTIMATE)

September 23, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGI-ALS-III-01
  • Orphan Drug:01-1527

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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