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document
A study to evaluate safety and tolerability of repeated doses of tirasemtiv in patients with amyotrophic lateral sclerosis . Abstract Tirasemtiv is a fast skeletal muscle activator that increases the sensitivity of the sarcomere to calcium , increasing the efficiency of muscle contraction when the muscle is stimulated at submaximal contraction frequencies . A previous study showed single doses of tirasemtiv to be well tolerated and associated with potentially important improvements in a variety of functional outcomes . This study determined safety of tirasemtiv when given at doses up to 500 mg daily for three weeks . Tirasemtiv was given as a single daily dose up to 375 mg for two weeks , with and without concomitant riluzole . In a separate cohort , an ascending dose protocol evaluated a total dose of 500 mg daily given in two divided doses . Safety and tolerability were assessed , as well as measures of function , muscle strength and endurance . Results showed that tirasemtiv was well tolerated , with dizziness the most common adverse event . Tirasemtiv approximately doubled the serum concentration of riluzole . Trends were noted for improvement in ALSFRS-R , Maximum Minute Ventilation , and Nasal Inspiratory Pressure . In conclusion , tirasemtiv is well tolerated and can be given safely with a reduced dose of riluzole . Positive trends in multiple exploratory outcome measures support the further study of this agent in ALS .
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Intervention_Pharmacological
tirasemtiv
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Intervention_Pharmacological
Abstract Tirasemtiv
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Intervention_Pharmacological
tirasemtiv
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Intervention_Pharmacological
Tirasemtiv
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Outcome_Other
safety
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Outcome_Other
tolerability
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Outcome_Other
safety
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Outcome_Other
Safety and tolerability
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Outcome_Physical
measures of function , muscle strength and endurance
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Outcome_Other
tolerated
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Outcome_Adverse-effects
dizziness
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Outcome_Physical
serum concentration of riluzole
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Outcome_Physical
ALSFRS-R , Maximum Minute Ventilation , and Nasal Inspiratory Pressure
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Outcome_Other
safely
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Participant_Condition
amyotrophic lateral sclerosis
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Participant_Condition
ALS