At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 42 enrolled
Drug / intervention
Botulinum toxin type A +1 morebiological
Likely dose
Not stated in 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.
Asian Multicentre, Double Blind, Randomised, Placebo Controlled Pilot Study, to Assess the Impact of Dysport® Intramuscular Injections When Administered Within the First 12 Weeks After Stroke on the Time to Spasticity Progression in Adult Subjects With Upper Limb (UL) Spasticity.
In Brief
A Phase 4 clinical trial evaluating Botulinum toxin type A and Placebo for Stroke and Upper Limb Spasticity. Completed, enrolled 42 participants across 4 sites in 4 countries.
Detailed Summary
The purpose of this study is to investigate if early administration (i.e. within 12 weeks after stroke) of Dysport® 500 U injections may delay the appearance or the progression of upper limb symptomatic spasticity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Upper Limb Spasticity
CountriesMalaysia, Philippines, Singapore, Thailand
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedDec 2014
Primary CompletionMar 2016
TodayJul 2026
First PostedDec 22, 2014
Enrollment StartDec 1, 2014
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.5 years ago
Interventions
Botulinum toxin type Abiological
Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb.
Placebodrug
Placebo administered intramuscularly in the targeted upper limb.