A randomised sequential trial of Lithium in amyotrophic lateral sclerosis
- Conditions
- amyotrophic lateral sclerosis (ALS)motor neuron disease10029317
- Registration Number
- NL-OMON31977
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 191
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
3. A disease duration (at inclusion) of more than 6 months and less than 36 months
(disease onset is defined as the date of first symptoms excluding muscle cramps and fasciculations)
4. Vital capacity (VC%) >= 70 % of normal value
(slow expiration, best of a minimum of three and a maximum of five measurements, with a respiratory function validly assessable and spontaneous, non-assisted ventilation)
5. Age 18 - 85 years (inclusive)
6. Capable of thoroughly understanding the trial information given; has signed the informed consent.
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.
3. Presence of any concomitant life-threatening disease or any disease or impairment likely to interfere with functional assessment.
4. Contra indications for lithium therapy*.
5. Interaction of lithium with other medication.
*Renal failure. Severe cardiac diseases. Brain damage. Addison disease. Hypothyroidism unresponsive to thyroid hormone suppletion. Precaution in patients with a (possibly) disturbed sodiumbalance like in extreme perspiration and sodium depleted diet.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is survival. Survival is defined as the time from<br /><br>inclusion to reaching a clinical endpoint. A clinical endpoint is reached when<br /><br>death, tracheostomy, permanent assisted ventilation (PAV) or non-invasive<br /><br>ventilation (NIV) for over 16 hours occurs. Permanent assisted ventilation is<br /><br>defined as intubation with artificial ventilation ultimately leading to<br /><br>tracheostomy or death</p><br>
- Secondary Outcome Measures
Name Time Method <p>A secundary study parameter is the rate of decline in daily functioning and the<br /><br>occurrence of adverse effects and events.</p><br>