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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

Tracking Information
First Submitted Date  ICMJE June 19, 2009
First Posted Date  ICMJE June 22, 2009
Last Update Posted Date October 31, 2012
Study Start Date  ICMJE June 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2009)
Survival in patients with ALS treated with lithium and riluzole compared to historical cohort (patients treated with riluzole alone ) [ Time Frame: 15 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2009)
  • Functional Assessment Change in ALS Functional Rating Score (ALSFRS-R slope) [ Time Frame: 15 months ]
  • Muscle Strength Change in MMT score (MMT slope) [ Time Frame: 15 months ]
  • Rate of decline of respiratory function determined as SVC over the 15 month treatment period [ Time Frame: 15 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.)
Study Arms  ICMJE 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
Actual Enrollment  ICMJE
 (submitted: October 30, 2012)
23
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2009)
200
Actual Study Completion Date  ICMJE April 2011
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00925847
Other Study ID Numbers  ICMJE P080401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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