A Phase 2/3, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy.

Registry ID
EUCTR2010-019159-23
Source registry
EUCTR
Status
Completed
Phase
PHASE3
Sponsor
Allon Therapeutics Inc
Start date
2010-11-08
Completion date
2012-11-06
Last update
2026-08-16

Conditions

Summary

To evaluate davunetide 30 mg BID relative to placebo, when both are administered IN for 52 weeks, to subjects with PSP, with respect to: - Efficacy, as measured by change from baseline scores of the Progressive Supranuclear Palsy Rating Scale (PSPRS) at 52 weeks. - Efficacy, as measured by the change from baseline of the Schwab and England Activities of Daily Living Scale (SEADL) at 52 weeks. - Safety, as measured by reported adverse events (AEs), electrocardiograms (ECGs), nasal examination and clinical laboratory measures.

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