Study to Assess the Efficacy and Safety of Dysport® in the Treatment of Chronic Plantar Fasciitis

Phase 2/3 Completed 40 enrolled Ipsen

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will investigate the hypothesis that the analgesic effect of a single injection of Dysport (200 MU) induces a significant reduction of symptoms in chronic cases of plantar fasciitis.

Timeline

Start: 2005-07
Primary completion: 2009-01
Completion: 2009-04

Outcome

Missed primary endpoint

registry analysis (unspecified test); Dysport ® 200 U vs Placebo; p =0.182; Treatment difference 0.20 (95% CI -0.06 to 0.46); Fisher Exact NCT00447876 ↗

paper More patients in the BoNT-A group achieved a response at week 6 (25% vs. 5% for placebo; P=0.18). PMID 22673486 ↗

Publications

Results Peterlein CD, Funk JF, Holscher A, Schuh A, Placzek R. Is botulinum toxin A effective for the treatment of plantar fasciitis? Clin J Pain. 2012 Jul;28(6):527-33. doi: 10.1097/AJP.0b013e31823ae65a.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	200 iu	Other