ithium trial in ALS
Completed
- Conditions
- amyotrophic lateral sclerosisamyotrofe laterale scleroseALSlithium
- Registration Number
- NL-OMON21077
- Lead Sponsor
- Prof.dr L.H. van den Berg, neurologist in the University Hospital of Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 191
Inclusion Criteria
1. Definite, probable, or probable-laboratory supported ALS according to the revised El Escorial World Federation of Neurology criteria.
2. Intake of riluzole 2dd 50 mg
Exclusion Criteria
1. Tracheostomy, tracheostomal ventilation of any type, non-invasive ventilation more than 16 hours/ day, or supplemental oxygen during the last three months prior to inclusion.
2. Any medical condition or intoxication known to have an association with motor neuron dysfunction, which might confound or obscure the diagnosis of ALS.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival:<br /><br> survival is defined as the time from inclusion to reaching a clinical endpoint. A clinical endpoint is reached when death, tracheostomy, permanent assisted ventilation (PAV) or non-invasive ventilation (NIV) for over 16 hours occurs. Permanent assisted ventilation is defined as intubation with artificial ventilation ultimately leading to tracheostomy or death.
- Secondary Outcome Measures
Name Time Method - The rate of decline in daily functioning:<br /><br>The ALS Functional Rating Scale” (ALSFRS-R) is an easily applicable questionnaire, to assess the opinion of the patient regarding his/her own possibilities and/or dependency in the activities of daily living. The rate of decline of the ALSFRS-R will be measured from inclusion to the clinical endpoint.