Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

— LISLA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925847
• Other study ID #: P080401
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2009
• Last updated: October 30, 2012
• Start date: June 2009
• Est. completion date: April 2011

Study information

• Verified date: March 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• lithium
lithium LP 400mg daily po (doses were adjusted during the study to maintain targeted blood levels.)

Locations

Country	Name	City	State
France	Pitié-Salpêtrière Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival in patients with ALS treated with lithium and riluzole compared to historical cohort (patients treated with riluzole alone )		15 months	Yes
Secondary	Functional Assessment Change in ALS Functional Rating Score (ALSFRS-R slope)		15 months	No
Secondary	Muscle Strength Change in MMT score (MMT slope)		15 months	No
Secondary	Rate of decline of respiratory function determined as SVC over the 15 month treatment period		15 months	No