Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis (LISLA)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT00925847

First received: June 19, 2009

Last updated: October 30, 2012

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 19, 2009

Last Updated Date

October 30, 2012

Start Date ^ICMJE

June 2009

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Survival in patients with ALS treated with lithium and riluzole compared to historical cohort (patients treated with riluzole alone ) [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00925847 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Functional Assessment Change in ALS Functional Rating Score (ALSFRS-R slope) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Muscle Strength Change in MMT score (MMT slope) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Rate of decline of respiratory function determined as SVC over the 15 month treatment period [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis

Official Title ^ICMJE

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 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Amyotrophic Lateral Sclerosis

Intervention ^ICMJE

Drug: lithium

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

Other Name: lithium

Study Arm (s)

Experimental: 1

Intervention: Drug: lithium

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00925847

Other Study ID Numbers ^ICMJE

P080401

Has Data Monitoring Committee

Responsible Party

Assistance Publique - Hôpitaux de Paris

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lucette Lacomblez, MD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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