drugset
drugset / Trial / NCT01457352

Efficacy and Safety of SPARC0921 in Subjects With Spasticity

NCT01457352 ↗

Phase 3 Completed 392 enrolled Sun Pharma Advanced Research Company Limited
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.

Timeline

Start
2012-11-14
Primary completion
2017-08-25
Completion
2017-08-25

Outcome

Missed primary endpoint

registry analysis (superiority test); SPARC0921 vs Placebo0921; p = 0.2062; Cochran-Mantel-Haenszel NCT01457352 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject SPARC0921 Unknown — —

Indications

No indication recorded.