A Clinical Trial of Creatine in ALS

Study Purpose:

Mitochondrial dysfunction occurs early in the course of ALS, and the mitochondria may be an important site for therapeutic intervention. Creatine stabilizes the mitochondrial transition pore, and is important in mitochondrial ATP production. In a transgenic mouse model of ALS, administration of creatine prolongs survival and preserves motor function and motor neurons.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Not enrolling

Phase:

Study Chair(s)/Principal Investigator(s):

Jeremy Shefner (SUNY)

Clinicaltrials.gov ID (11 digit #):

Neals Affiliated?

Yes

Coordinating Center Contact Information


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Full Study Summary:

Study Sponsor:

Participant Duration:

Estimated Enrollment:

104

Estimated Study Start Date:

09/01/2000

Estimated Study Completion Date:

09/30/2002

Posting Last Modified Date:

05/09/2019

Date Study Added to alsconsortium.org:

05/09/2019
  • Eligibility Criteria

    Gender:

    Neals Affiliated, Diseases, Study Type, Study Category, Study Status, Phase

    Minimum Age:

    N/A

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


  • Site Contact Information
  • Study Results

    RESULTS:

    Creatine was tolerated well, but no benefit of creatine could be demonstrated in any outcome measure. CI analysis showed that the study, although powered to detect a 50% or greater change in rate of decline of muscle strength, actually made an effect size of greater than 23% unlikely. It was also demonstrated that motor unit number estimation was performed with acceptable reproducibility and tolerability, and may be a useful outcome measure in future clinical trials.

    CONCLUSION:

    Any beneficial effect of creatine at 5 g per day in ALS must be small. Other agents should be considered in future studies of therapeutic agents to address mitochondrial dysfunction in ALS. In addition, motor unit number estimation may be a useful outcome measure for future clinical trials in ALS.

    Full Study Summary