Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis

Condition(s) targeted: Amyotrophic Lateral Sclerosis

Intervention: lithium (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Lucette Lacomblez, MD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris

The purpose of the study is to determine whether lithium is safe and effective in the treatment of ALS

Official title: Open Multicenter Study of Lithium in Patients With Amyotrophic Lateral Sclerosis LISLA

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Survival in patients with ALS treated with lithium and riluzole compared to historical cohort (patients treated with riluzole alone )

Secondary outcome:

Functional Assessment Change in ALS Functional Rating Score (ALSFRS-R slope)

Muscle Strength Change in MMT score (MMT slope)

Rate of decline of respiratory function determined as SVC over the 15 month treatment period

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of clinically possible, clinically probable laboratory-supported,

clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the AIRLIE House Conference 1998)

- Concomitant standard Riluzole therapy (50mg twice daily)

- patients included in ALS reference center

- women of childbearing age be non-lactating and surgically sterile or using a highly

effective method of birth control and have a negative pregnancy test

- capable of thoroughly understanding all information given and giving full informed

consent according to GCP

- Patients with gastrostomy

Exclusion Criteria:

- evidence of major psychiatric disorder or clinically evident dementia precluding

evaluation of symptoms

- any medical condition known to contre-indicate lithium treatment (dysthyroid,

cardiopathy, renal insufficiency)

- presence of any concomitant life-threatening disease or impairment likely to

interfere with functional assessment

- known hypersensitivity to any component of the study drugs

Pitié-Salpêtrière Hospital, Paris 75013, France

Starting date: June 2009
Last updated: October 30, 2012