Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 19, 2009
October 30, 2012
June 2009
April 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00925847 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis
Open Multicenter Study of Lithium in Patients With Amyotrophic Lateral Sclerosis LISLA

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
Drug: lithium
lithium LP 400mg daily po (doses were adjusted during the study to maintain targeted blood levels.)
Other Name: lithium
Experimental: 1
Intervention: Drug: lithium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00925847
P080401
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Lucette Lacomblez, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP