Merz Pharmaceuticals (Merz) has reported that its NT 201, botulinum toxin type A free from complexing proteins (also known as Xeomin in Europe and Canada), was more efficacious than placebo for the treatment of patients with post-stroke upper limb spasticity.
Reportedly, the phase III study assessed the impact of NT 201 on muscle tone, functional disability and caregiver burden in patients, utilising a randomised, placebo-controlled, double-blind design.
The phase III study conducted at 23 sites in Europe, included patients who, at least 6 months prior to enrollment, had experienced a stroke resulting in focal spasticity of the wrist and finger flexors. Participants were required to have DAS scores of 2 or higher in their chosen therapeutic target domain: dressing, limb position, hygiene or pain.
The result suggested that in Carer Burden Scale assessments, a significant advantages for NT 201 were shown at week 4 in the tasks of putting the affected arm through a sleeve and for cleaning the palm of the affected hand.
In the trail, a higher proportion of patients receiving NT 201 were responders in terms of improvement in the wrist flexors four weeks after treatment. Responders were defined as patients with at least 1 point of improvement in the Ashworth Scale Score.
Petr Kanovsky, primary investigator of the phase III study, said: “In addition to the impact it has on the day-to-day life activities, post-stroke spasticity can cause significant pain and discomfort to patients. The positive outcomes presented in this study suggest NT 201 may give promise to patients in search of a treatment option for post-stroke spasticity.”