MedDataX Logo

Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis

NCT ID: NCT00925847

Last Updated: 2012-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amyotrophic Lateral Sclerosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Amyotrophic lateral sclerosis Lithium Survival

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

lithium

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lithium

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lucette Lacomblez, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pitié-Salpêtrière Hospital

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P080401

Identifier Type: -

Identifier Source: org_study_id