Ipsen has reported positive data from the ENGAGE clinical trial of Dysport (abobotulinumtoxinA) in adults with upper and lower limb spastic hemiparesis.
In the study, the drug candidate was given concurrently with a personalised diary-based rehabilitation programme called guided self-rehabilitation contract (GSC).
Spasticity is characterised by the continuous contraction of some muscles, leading to stiffness or tightness that may impact movement, speech and gait.
Dysport is an injectable formulation of botulinum neurotoxin type A, which is obtained from Clostridium bacteria and blocks the transmission of nerve impulses. This helps to decreases muscular contractions.
The international, prospective, single-arm Phase IIIb/IV ENGAGE study evaluated the effect of Dysport on voluntary movements of the upper and lower limb in 160 patients.
Patients were given 1,500U aboBoNT-A dose during each injection cycle, along with personalised GSC.
The primary efficacy endpoint of the study was the proportion of patients responding at week 6 following the second injection, based on the composite active range of motion (CXA) in the primary treatment target (PTT) limb.
According to the trial results, 72.1% of the participants experienced a CXA improvement threshold in the PTT limb of ≥35° in upper limbs or ≥5° in the lower limbs.
Ipsen added that the results were supported by the time to reinjection, where the mean time and median time to reinjection were 110.1 days and 106.5 days, respectively.
The time to reinjection in the study was longer than prior upper and lower limb studies that did not include GSC. The safety profile was also consistent with the known abobotulinumtoxinA profile.
Ipsen R&D Neurosciences medical affairs vice-president Antony Fulford-Smith said: “Through ENGAGE, we have been able to demonstrate for the first time the benefit of combining treatment with Dysport with a systematic rehabilitation protocol, validating the positive impact of encouraging patients to take an active role in their own treatment.”
The trial was conducted in the US, Czech Republic, France and Russia.