CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12 enrolled
Drug / intervention
Dysport Injectable Productdrug
Likely dose
Dysport Injectable Product 15 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03469999
NCT03469999Phase 3Completed
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Effect of Single Event Multi Level Chemoneurolysis With Dysport on Energy Expenditure and Walking Efficiency

Columbia University·interventional·Posted Mar 19, 2018·Updated Jun 1, 2022

In Brief

A Phase 3 clinical trial evaluating Dysport Injectable Product for Cerebral Palsy. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This study aims to evaluate the efficacy of single event multi level chemoneurolysis with the abobotulinumtoxin A drug, Dysport®, on walking energy expenditure and gait in children with spastic diplegia cerebral palsy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebral Palsy
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 19, 2018
Enrollment StartDec 12, 2018
Primary CompletionMay 26, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 8.3 years ago

Interventions

Dysport Injectable Productdrug

Selected dose of medication will be determined by affected muscle(s), severity of spasticity, and the patient's body weight. We will follow the recommended total Dysport dose of 10-15 units/kg per limb, not to exceed 15 units/kg for unilateral lower limb, 30 units/kg for bilateral lower limb, or a total of 1000 units, whichever is lower in a given session.