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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00925847
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
The purpose of the study is to determine whether lithium is safe and effective in the treatment of ALS

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: lithium Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Multicenter Study of Lithium in Patients With Amyotrophic Lateral Sclerosis LISLA
Study Start Date : June 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: lithium
lithium LP 400mg daily po (doses were adjusted during the study to maintain targeted blood levels.)


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Functional Assessment Change in ALS Functional Rating Score (ALSFRS-R slope) [ Time Frame: 15 months ]
  2. Muscle Strength Change in MMT score (MMT slope) [ Time Frame: 15 months ]
  3. Rate of decline of respiratory function determined as SVC over the 15 month treatment period [ Time Frame: 15 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925847


Locations
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France
Pitié-Salpêtrière Hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Lucette Lacomblez, MD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00925847    
Other Study ID Numbers: P080401
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: March 2009
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Amyotrophic lateral sclerosis
Lithium
Survival
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
 Metabolic Diseases
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs