Cytokinetics has announced that patient enrollment for its VITALITY-ALS clinical trial to assess effects of tirasemtiv on respiratory function in ALS patients is complete.
VITALITY-ALS (NCT02496767) is an international, randomized, double-blind and placebo-controlled trial in patients with possible, probable, or definite ALS. The study’s primary endpoint will measure, after 24 weeks, changes from baseline of slow vital capacity (SVC). Secondary endpoints include, among other measures of skeletal muscle strength, time to decline from baseline in percent predicted SVC by ? 20 percentage points, or the onset of respiratory insufficiency; time to decline from baseline in percent predicted SVC to ? 50 percent predicted, or the onset of respiratory insufficiency; and time to first occurrence of any use of assisted ventilation.
Patients enrolled in the trial will receive two-weeks of open-label treatment with tirasemtiv administered at 250 mg/day, and will be then randomized to either placebo or to one of three target tirasemtiv dose levels (250 mg/day, 375 mg/day, 500 mg/day) for 48 weeks. Ttirasemtiv-treated patients will then continue for another four-week withdrawal period, randomized to either continuing receiving their current dosage or a placebo, and placebo-treated patients will continue on placebo.
At the study’s conclusion, all patients will be eligible to continue or start receiving tirasemtiv in an open-label study extension phase.