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Safety and Efficacy Study of Creatine and Tamoxifen in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

NCT01257581 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-12-04

Study results available
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Summary

The purpose of the study is to evaluate the safety and efficacy of high dose creatine and two dosages of tamoxifen treatment in amyotrophic lateral sclerosis (ALS).

Conditions

Interventions

DRUG

creatine

creatine monohydrate powder

DRUG

tamoxifen

Tamoxifen citrate capsules

Sponsors & Collaborators

  • ALS Therapy Alliance

    collaborator OTHER

  • State University of New York - Upstate Medical University

    collaborator OTHER

  • Nazem Atassi

    lead OTHER

Principal Investigators

  • Nazem Atassi, MD, MMSc · Masaschusetts General Hospital, Boston, MA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-12-31
Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01257581 on ClinicalTrials.gov