In the current issue of Neurology
, detailed results from a Phase 3 (NCT01249404
) and its open-label extension study (NCT01251367
) demonstrating the efficacy and safety of Dysport (abobotulinumtoxinA) in adult patients with lower limb spasticity following a stroke or traumatic brain injury have been published.
The results of the studies, which proved that Dysport can lead to improvements in adults with hemiparesis who experienced lower limb spasticity, led to the U.S. Food and Drug Administration (FDA) approval of Dysport for the treatment of this patient population in June. The study was also previously the impetus for marketing authorization in other key markets, including the UK and Germany.
Hemiparesis is weakness on one entire side of the patient’s body. In its most severe form – hemiplegia – it completely paralyzes half of the body, and can be caused by congenital causes, trauma, tumors, or stroke.
Dysport is an injectable form of a botulinum neurotoxin type A (BonT-A) product, and reduces muscular contractions because it is derived from Clostridium bacteria producing BoNT-A that can inhibit the effective transmission of nerve impulses. It is currently indicated for adults with cervical dystonia and spasticity in adult patients, as well as lower limb spasticity in pediatric patients 2 years and up.
The Phase 3 was a randomized, double-blind, placebo-controlled study, sponsored by Ipsen, that enrolled 381 adult patients, 253 of whom received Dysport, and 128 who received placebo. Patients were randomized to Dysport 1000 Units (n
=125), Dysport 1500 Units (n
=128), or placebo (n
=128) injected intramuscularly into the muscles within the gastrocnemius-soleus complex (GSC), located in the calf.
The open-label extension had the primary endpoint long-term safety and long-term efficacy as a secondary endpoint.
“This publication in Neurology demonstrates both the short-term efficacy of Dysport in improving muscle tone in adult patients with lower limb spasticity and also the long-term improvements with repeated treatment cycles,” said Professor Jean-Michel Gracies, Neurorehabilitation, Neurology & Neurophysiology, Chairman of the Department of Neurorehabilitation at the Groupe Hospitalier Albert CHENEVIER - Henri MONDOR in a press release
. “Dysport was shown to improve outcomes for these patients, including substantial improvements in walking speed.”
The Phase 3 study concluded that Dysport 1500 Units injection resulted in a statistically significant improvement in muscle tone and spasticity at the ankle joint. Throughout the open-label extension, the tolerability profile of the therapy remained consistent, and it exhibited its efficaciousness across repeated treatment cycles.
“The results of the Phase III studies (double-blind and open-label) published this month in Neurology underline the significant clinical benefit for adult patients with lower limb spasticity who received repeated injections of Dysport,” said Alexandre Lebeaut, Executive Vice President R&D and Chief Scientific Officer, Ipsen. “Similar to what we observed in adults with upper limb spasticity, many of these patients experienced a duration of response between 12-16 weeks, and some patients ever experienced a longer duration of response up to 20 weeks.”
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