A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants with Amyotrophic Lateral Sclerosis

Conditions

Amyotrophic Lateral Sclerosis

Brief summary

Change from baseline through Week 26 in the ALSFRS-R total score adjusted for mortality. Change from baseline through Week 48 in the ALSFRS-R total score adjusted for mortality.

Detailed description

Overall survival at Week 96, Change from baseline through Week 26, Week 48 in Speaking rate as measured by quantitative speech assessment in the clinic. Change from baseline through Week 48 in Intelligibility of speech as measured by quantitative speech assessment in the clinic., Change from baseline through Week 48 in percent predicted slow vital capacity, Change from baseline through Week 48 in the Bulbar subdomain of the ALSFRS-R, Change from baseline through Week 48 in the ALSAQ-40, Incidence, nature, and severity of treatment emergent adverse events, adverse events of special interest, and serious adverse events. Incidence and shifts of clinically significant abnormalities in ECG, laboratory tests, and vital signs. Change from baseline in C-SSRS. Tolerability.

Related papers

No related papers found yet.

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPRIDOPIDINE

DRUGPridopidine placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline through Week 26 in the ALSFRS-R total score adjusted for mortality. Change from baseline through Week 48 in the ALSFRS-R total score adjusted for mortality.	—

Secondary

Measure	Time frame
Overall survival at Week 96, Change from baseline through Week 26, Week 48 in Speaking rate as measured by quantitative speech assessment in the clinic. Change from baseline through Week 48 in Intelligibility of speech as measured by quantitative speech assessment in the clinic., Change from baseline through Week 48 in percent predicted slow vital capacity, Change from baseline through Week 48 in the Bulbar subdomain of the ALSFRS-R, Change from baseline through Week 48 in the ALSAQ-40, Incidence, nature, and severity of treatment emergent adverse events, adverse events of special interest, and serious adverse events. Incidence and shifts of clinically significant abnormalities in ECG, laboratory tests, and vital signs. Change from baseline in C-SSRS. Tolerability.	—

Measure

Time frame

Overall survival at Week 96, Change from baseline through Week 26, Week 48 in Speaking rate as measured by quantitative speech assessment in the clinic. Change from baseline through Week 48 in Intelligibility of speech as measured by quantitative speech assessment in the clinic., Change from baseline through Week 48 in percent predicted slow vital capacity, Change from baseline through Week 48 in the Bulbar subdomain of the ALSFRS-R, Change from baseline through Week 48 in the ALSAQ-40, Incidence, nature, and severity of treatment emergent adverse events, adverse events of special interest, and serious adverse events. Incidence and shifts of clinically significant abnormalities in ECG, laboratory tests, and vital signs. Change from baseline in C-SSRS. Tolerability.

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Outcome results

None listed