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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
  Purpose

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


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
 Drug: lithium
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Multicenter Study of Lithium in Patients With Amyotrophic Lateral Sclerosis LISLA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 23
Study Start Date: June 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: lithium
lithium LP 400mg daily po (doses were adjusted during the study to maintain targeted blood levels.)
Other Name: lithium

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925847

Locations
France
Pitié-Salpêtrière Hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Lucette Lacomblez, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00925847     History of Changes
Other Study ID Numbers: P080401
Study First Received: June 19, 2009
Last Updated: October 30, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Amyotrophic lateral sclerosis
Lithium
Survival

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes
Lithium
 Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013