Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Lithium Carbonate

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