Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

Summary

The purpose of this study is to compare the effectiveness of lithium combined with riluzole to riluzole combined with placebo in people with amyotrophic lateral sclerosis.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

DRUG

Lithium Carbonate

Participants will receive capsules that contain 150 milligrams (mg) lithium carbonate. Participants will be randomized to lithium/riluzole or placebo/riluzole and treated for 52 weeks. Participants originally randomized to placebo who fail (progress) will crossover to lithium for the remainder of the trial.

DRUG

Riluzole

All participants enrolled in this study will be taking a stable dose of riluzole 50 milligrams (mg) by mouth (PO) twice per day (BID) for at least 30 days prior to screening.

DRUG

placebo

an inactive substance

Sponsors & Collaborators

• ALS Association

  collaborator OTHER

• ALS Society of Canada

  collaborator OTHER_GOV

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• University of Toronto

  collaborator OTHER

• State University of New York - Upstate Medical University

  collaborator OTHER

• Columbia University

  collaborator OTHER

• University of Kentucky

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Merit Cudkowicz, MD, MSc · Massachusetts General Hospital

• Swati Aggarwal, MD · Massachusetts General Hospital

• Lorne Zinman, MD, MSc, FRCPC · Sunnybrook Health Sciences Center, Univ. of Toronto, Toronto, CA

• Jinsy Andrews, MD · Columbia University, New York, NY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2009-10-31

Completion

2009-10-31

Countries

• United States
• Canada

Study Locations