drugset / Trial / NCT01682148

Comparing Lower-concentration Dysport Treatment Targeted to the Neuromuscular Junction With Current Clinical Practice

NCT01682148 ↗

Phase 3 Terminated 100 enrolled Ipsen
RandomizedParallel-groupSingle-blindTreatment

Summary

The aim of the study was to compare Dysport treatment results (as assessed by Modified Ashworth Scale (MAS) in the elbow joint 4 weeks post treatment) following two treatment techniques: the current clinical practice injection technique using high-concentration dilution (300 U/mL Dysport) versus the neuromuscular junction (NMJ)-targeted injection technique using low-concentration dilution (100 U/mL Dysport). The hypothesis was that one high-volume, low-concentration injection located centrally in the area/band of the NMJ zones would be as effective as the technique used in current medical practice.

Timeline

Start
2012-09
Primary completion
2015-03
Completion
2015-03

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated early due to slow recruitment.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic — —

Indications

No indication recorded.