Abstract | BACKGROUND: METHODS/DESIGN: LiCALS is a multi-centre double-blind randomised parallel group controlled trial of the efficacy, safety, and tolerability of lithium carbonate (LiCO3) at doses to achieve stable 'therapeutic' plasma levels (0.4-0.8 mmol/L), plus standard treatment, versus matched placebo plus standard treatment, in patients with amyotrophic lateral sclerosis. The study will be based in the UK, in partnership with the MND Association and DeNDRoN (the Dementias and Neurodegnerative Diseases Clinical Research Network). 220 patients will be recruited. All patients will be on the standard treatment for ALS of riluzole 100 mg daily. The primary outcome measure will be death from any cause at 18 months defined from the date of randomisation. Secondary outcome measures will be changes in three functional rating scales, the ALS Functional Rating Scale-Revised, The EuroQOL (EQ-5D), and the Hospital Anxiety and Depression Scale.Eligible patients will have El Escorial Possible, Laboratory-supported Probable, Probable or Definite amyotrophic lateral sclerosis with disease duration between 6 months and 36 months (inclusive), vital capacity ≥ 60% of predicted within 1 month prior to randomisation and age at least18 years. DISCUSSION: Patient recruitment began in June 2009 and the last patient is expected to complete the trial protocol in November 2011. TRIAL REGISTRATION: Current controlled trials ISRCTN83178718.
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Authors | Ammar Al-Chalabi, Pamela J Shaw, Carolyn A Young, Karen E Morrison, Caroline Murphy, Marie Thornhill, Joanna Kelly, I Nicholas Steen, P Nigel Leigh, UKMND-LiCALS |
Journal | BMC neurology
(BMC Neurol)
Vol. 11
Pg. 111
(Sep 21 2011)
ISSN: 1471-2377 [Electronic] England |
PMID | 21936930
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Neuroprotective Agents
- Placebos
- Lithium Carbonate
- Riluzole
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Topics |
- Adult
- Amyotrophic Lateral Sclerosis
(drug therapy, mortality)
- Clinical Protocols
- Double-Blind Method
- Drug Therapy, Combination
(statistics & numerical data)
- Female
- Humans
- Lithium Carbonate
(adverse effects, therapeutic use)
- Male
- Neuroprotective Agents
(adverse effects, therapeutic use)
- Placebos
(therapeutic use)
- Psychiatric Status Rating Scales
- Riluzole
(therapeutic use)
- Severity of Illness Index
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