Efficacy, safety and tolerabiilty of minocycline in amyotrophic lateral sclerosis

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There is now convincing evidence that minocycline has potent neuroprotective properties in a mouse model of amyotrophic lateral sclerosis (ALS). We propose to carry out a multi-centre, international, double-blind randomised parallel group stratified controlled trial (?EMINALS?) of the efficacy safety and tolerability of minocycline (200mg daily) plus riluzole 100mg daily against placebo plus riluzole 100mg daily in patients with ALS. The primary efficacy measure is survival at 18 months. To detect a 10% difference in the number of events (deaths) at 18 months (hazard ratio 0.75) with 90% power and a=0.05 (two-sided) 1000 patients (500 in each limb) are required. Secondary outcome measures will include the ALS Functional Rating Scale-R (ALSFRS-R), the Euroqol EQ-5D, and a Client Service Receipt Inventory (CSRI) for health economics studies. Such a study will have important implications for the treatment of ALS and will also test a scientific hypothesis of fundamental importance for neurodegenerative diseases.