Clinical Trial: Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Open Multicenter Study of Lithium in Patients With Amyotrophic Lateral Sclerosis LISLA
Brief Summary: The purpose of the study is to determine whether lithium is safe and effective in the treatment of ALS
Detailed Summary:
Daily doses of lithium, have been found to delay progression of amyotrophic lateral sclerosis (ALS) in a 15-month study of 44 patients with ALS. At the end of the trial, about 30 percent of the patients that took riluzole had died, while all those receiving riluzole plus lithium had survived. the lithium group had slower progression as measure by a test of breathing (FVC) and strength.
This study will determine whether lithium in combination with riluzole delay progression of patients with amyotrophic lateral sclerosis disease in comparison of an historical cohort of ALS patients treated with riluzole alone.
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: Survival in patients with ALS treated with lithium and riluzole compared to historical cohort (patients treated with riluzole alone ) [ Time Frame: 15 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Functional Assessment Change in ALS Functional Rating Score (ALSFRS-R slope) [ Time Frame: 15 months ]
- Muscle Strength Change in MMT score (MMT slope) [ Time Frame: 15 months ]
- Rate of decline of respiratory function determined as SVC over the 15 month treatment period [ Time Frame: 15 months ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: June 19, 2009
Date Started: June 2009
Date Completion:
Last Updated: October 30, 2012
Last Verified: March 2009
