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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

lithium

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic lateral sclerosis, Lithium, Survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pitié-Salpêtrière Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00925847

First Posted

June 19, 2009

Last Updated

October 30, 2012

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00925847

Brief Title

Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis

Acronym

LISLA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosis, Lithium, Survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

lithium

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

15 months

Secondary Outcome Measure Information:

Title

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

Time Frame

15 months

Title

Muscle Strength Change in MMT score (MMT slope)

Time Frame

15 months

Title

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

Time Frame

15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lucette Lacomblez, MD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pitié-Salpêtrière Hospital

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

Learn more about this trial

Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis

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