Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis

Sponsor

The Avicena Group (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00069186

Collaborator

(none)

107

Enrollment

Locations

Duration (Months)

13.4

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jun 1, 2003

Study Completion Date :

Apr 1, 2005

Outcome Measures

Primary Outcome Measures

Change in upper extremity motor function after 3 weeks []
Change in upper extremity motor function after 9 months []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94115
2	University of Kansas	Kansas City	Kansas	United States	66160
3	University of New Mexico	Albuquerque	New Mexico	United States	87131
4	Carolinas Medical Center	Charlotte	North Carolina	United States	28203-5812
5	Duke University Medical Center	Durham	North Carolina	United States	27705
6	Oregon Health Sciences University	Portland	Oregon	United States	97239
7	University of Texas Health Science Center	San Antonio	Texas	United States	48284-7883
8	University of Virginia Health System	Charlottesville	Virginia	United States	22908