A phase 2b, multinational, randomized, double-blind study to investigate the efficacy and safety of redasemtide (S-005151) compared with placebo in adult participants with acute ischemic stroke

Conditions

acute ischemic stroke

Brief summary

mRS score at Day 90

Detailed description

1.Proportion of participants with mRS score of 0 to 2 at Day 90, 2.Proportion of participants with BI score ≥ 95 at Day 90, 3.mRS score at Day 30, 4.mRS score at Day 180, 5.Proportion of participants with mRS score of 0 or 1 at each visit, 6.Proportion of participants with mRS score of 0 to 2 at each visit except Day 90, 7.Proportion of participants with mRS score of 5 or 6 at each visit, 8.Proportion of participants with NIHSS score of 0 or 1 at each visit, 9.Proportion of participants with improvement from baseline of at least 8 points in NIHSS score at each visit, 10.Proportion of participants with NIHSS score deterioration of at least 4 points from baseline at each visit, 11.Change from baseline in NIHSS score at each visit, 12.Proportion of participants with BI score ≥ 95 at each visit except Day 90, 13.Change from Day 5 in SF-36 at each visit, 14.Change from Day 5 in SAQoL-39g at each visit, 15.PGI-C at each visit, 16.Change from Day 5 in PGI-S at each visit, 17.TEAEs, clinical laboratory tests, vital sign measurements (blood pressure, body temperature, respiratory rate, and pulse rate), ECGs and C-SSRS.

Related papers

No related papers found yet.

Interventions

DRUGPlacebo to match S-005151

DRUGS-005151

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
mRS score at Day 90	—

Secondary

Measure	Time frame
1.Proportion of participants with mRS score of 0 to 2 at Day 90, 2.Proportion of participants with BI score ≥ 95 at Day 90, 3.mRS score at Day 30, 4.mRS score at Day 180, 5.Proportion of participants with mRS score of 0 or 1 at each visit, 6.Proportion of participants with mRS score of 0 to 2 at each visit except Day 90, 7.Proportion of participants with mRS score of 5 or 6 at each visit, 8.Proportion of participants with NIHSS score of 0 or 1 at each visit, 9.Proportion of participants with improvement from baseline of at least 8 points in NIHSS score at each visit, 10.Proportion of participants with NIHSS score deterioration of at least 4 points from baseline at each visit, 11.Change from baseline in NIHSS score at each visit, 12.Proportion of participants with BI score ≥ 95 at each visit except Day 90, 13.Change from Day 5 in SF-36 at each visit, 14.Change from Day 5 in SAQoL-39g at each visit, 15.PGI-C at each visit, 16.Change from Day 5 in PGI-S at each visit, 17.TEAEs, clinical l	—

Measure

Time frame

1.Proportion of participants with mRS score of 0 to 2 at Day 90, 2.Proportion of participants with BI score ≥ 95 at Day 90, 3.mRS score at Day 30, 4.mRS score at Day 180, 5.Proportion of participants with mRS score of 0 or 1 at each visit, 6.Proportion of participants with mRS score of 0 to 2 at each visit except Day 90, 7.Proportion of participants with mRS score of 5 or 6 at each visit, 8.Proportion of participants with NIHSS score of 0 or 1 at each visit, 9.Proportion of participants with improvement from baseline of at least 8 points in NIHSS score at each visit, 10.Proportion of participants with NIHSS score deterioration of at least 4 points from baseline at each visit, 11.Change from baseline in NIHSS score at each visit, 12.Proportion of participants with BI score ≥ 95 at each visit except Day 90, 13.Change from Day 5 in SF-36 at each visit, 14.Change from Day 5 in SAQoL-39g at each visit, 15.PGI-C at each visit, 16.Change from Day 5 in PGI-S at each visit, 17.TEAEs, clinical l

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Countries

Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Spain

Outcome results

None listed