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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00925847 |
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Date of registration:
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19/06/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis
LISLA |
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Scientific title:
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Open Multicenter Study of Lithium in Patients With Amyotrophic Lateral Sclerosis LISLA |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00925847 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Lucette Lacomblez, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: lithium
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Primary Outcome(s)
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Survival in patients with ALS treated with lithium and riluzole compared to historical cohort (patients treated with riluzole alone )
[Time Frame: 15 months]
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Secondary Outcome(s)
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Rate of decline of respiratory function determined as SVC over the 15 month treatment period
[Time Frame: 15 months]
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Functional Assessment Change in ALS Functional Rating Score (ALSFRS-R slope)
[Time Frame: 15 months]
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Muscle Strength Change in MMT score (MMT slope)
[Time Frame: 15 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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