ISRCTN83178718
Completed
Phase 4
A double-blind randomised controlled trial of lithium carbonate in patients with amyotrophic lateral sclerosis
King's College London (UK)0 sites220 target enrollmentMay 8, 2009
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- King's College London (UK)
- Enrollment
- 220
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with possible, laboratory\-supported probable, probable or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria (The Airlie House Statement: http://www.wfnals.org). These criteria are internationally accepted research diagnostic criteria with high specificity and sensitivity. The onset form (bulbar or limb) and disease type (familial or sporadic) will be recorded; source documents will include a full report of an electromyogram (EMG) reported by an experienced neurophysiologist as compatible with ALS. The neurological exam should be performed by a physician.
- •2\. Disease duration greater than or equal to 6 months and less than or equal to 36 calendar months (inclusive), with disease onset defined as date of first muscle weakness, or dysarthria
- •3\. SVC greater than or equal to 60% of predicted within 1 month prior to randomisation
- •4\. Aged greater than or equal to 18 years (inclusive), either sex
- •5\. In the case of a female with childbearing potential, the patient must not be pregnant or breast\-feeding. Women of childbearing potential will have a urine pregnancy test before randomisation and at each clinic visit. The results of those must be negative. Women of childbearing potential should use adequate contraception.
- •6\. Continuously treated with riluzole for at least 4 weeks prior to screening (28 days inclusive) and stabilised at 100 mg/day (50 mg twice daily \[bid]) without significant adverse drug reactions
- •7\. Capable of understanding the information given and giving fully informed consent prior to any study specific procedures
Exclusion Criteria
- •1\. Participation in another therapeutic study within the preceding 12 weeks or use of other investigational drugs or agents
- •2\. Tracheostomy, or assisted ventilation of any type during the preceding three months
- •3\. Existing gastrostomy, unless elective and not currently used for nutritional support or hydration
- •4\. Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
- •5\. Presence of any concomitant life\-threatening disease or any disease or impairment likely to interfere with functional assessment
- •6\. Confirmed hepatic insufficiency or abnormal liver function (aspartate aminotransferase \[AST] or alanine aminotransferase \[ALT] greater than 1\.5 times the upper limit of the normal range) within one month of randomisation. That blood test may be repeated in the case of initial abnormal results; if the levels return to normal, the patient may then be included in the study.
- •7\. Renal insufficiency (serum creatinine greater than upper limit of normal \[ULN] for the centre/local laboratory) within one month of randomisation. That blood test may be repeated in the case of initial abnormal results; if the level returns to normal, the patient may then be included in the study.
- •8\. Recorded diagnosis or evidence of major psychiatric disorder or clinically evident dementia
- •9\. Known allergy or hypersensitivity to lithium, or its excipients
- •10\. Likely to be uncooperative or to fail to comply with the trial requirements or to be inaccessible in the event of an emergency
Outcomes
Primary Outcomes
Not specified
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