Open Multicenter Study of Lithium in Patients With Amyotrophic Lateral Sclerosis LISLA
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Survival in patients with ALS treated with lithium and riluzole compared to historical cohort (patients treated with riluzole alone )
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Intervention: lithium (Drug)
Outcomes
Primary Outcomes
Survival in patients with ALS treated with lithium and riluzole compared to historical cohort (patients treated with riluzole alone )
Time Frame: 15 months
Secondary Outcomes
- Functional Assessment Change in ALS Functional Rating Score (ALSFRS-R slope)(15 months)
- Muscle Strength Change in MMT score (MMT slope)(15 months)
- Rate of decline of respiratory function determined as SVC over the 15 month treatment period(15 months)