Status:
COMPLETED
Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00925847
Start Date
June 1 2009
End Date
April 1 2011
Last Update
October 31 2012
Active Locations (1)
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1
Pitié-Salpêtrière Hospital
Paris, France, 75013