NCT02969356: ENGAGE

An International, Multicentre, Prospective, Single-Arm Study to Assess the Effect on Voluntary Movements of AbobotulinumtoxinA 1500 U Administered in Both Upper and Lower Limbs in Conjunction With a Guided Self-Rehabilitation Contract in Adult Subjects With Spastic Hemiparesis

Completed Phase 4 Results posted Last updated 18 February 2025

What this trial tests

Phase 4 trial testing Botulinum toxin type A in Spastic Hemiparesis in 157 participants. Completed in 1 July 2018.

Timeline

18 December 2016

Primary endpoint
26 April 2018

1 July 2018

Quick facts

Lead sponsor	Ipsen
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	157
Start date	18 December 2016
Primary completion	26 April 2018
Estimated completion	1 July 2018
Sites	19 locations across United States, Czechia, France, Russia

Drugs / interventions tested

• Botulinum toxin type A (BOTULINUM TOXIN TYPE A) — full drug profile →
• GSC

Conditions studied

• Spastic Hemiparesis — all drugs for Spastic Hemiparesis →

Sponsor

Ipsen — full company profile →

Who can join

18 and older, any sex, with Spastic Hemiparesis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Responder Participants at Week 6 After the Second Injection, According to Composite Active Range of Motion (AROM) in the Primary TT Limb
  Time frame: At Week 6, Cycle 2
  Percentage of responder participants according to AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. A participant was considered a responder if he/she achieved at least the predefined impro

Sponsor's own description

The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®) injections in upper and lower limbs accompanied with a personal exercise plan called "Guided Self-rehabilitation Contract" (GSC) can improve voluntary movements in subjects with hemiparesis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Guided Self-rehabilitation Contracts Combined With AbobotulinumtoxinA in Adults With Spastic Paresis.
   Gracies JM, Francisco GE, Jech R, Khatkova S, et al · · 2021 · cited 8× · PMID 34039905 · DOI 10.1097/npt.0000000000000359