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

• ClinicalTrials.gov Identifier: NCT00925847
• Recruitment Status: Completed
• First Posted: June 22, 2009
• Last Update Posted: October 31, 2012
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: June 19, 2009
• First Posted Date: June 22, 2009
• Last Update Posted Date: October 31, 2012
• Study Start Date: June 2009
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Amyotrophic Lateral Sclerosis

Intervention

Drug: lithium

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

Study Arms

Experimental: 1

Intervention: Drug: lithium

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 30, 2012): 23
• Original Estimated Enrollment (submitted: June 19, 2009): 200
• Actual Study Completion Date: April 2011
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00925847
• Other Study ID Numbers: P080401
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Assistance Publique - Hôpitaux de Paris
• Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lucette Lacomblez, MD; Assistance Publique - Hôpitaux de Paris

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: March 2009