Clinical Trials

* On August 31, 2015, Ipsen announced that The Lancet Neurology has published online at the detailed results from the Ipsen sponsored phase III randomized study (NCT01313299) showing the efficacy and safety of Dysport® in post-stroke or traumatic brain injury patients with upper limb spasticity. This international phase III registration study led to the approval of Dysport® for the treatment of ULS in the US by the FDA on July 16, 2015. In Europe, the upper limb spasticity elements of the Dysport® SmPC have already been modified in some countries to include key medical data. Regulatory procedures are still ongoing in different European and Rest of World countries.
This new study met the primary endpoint (Modified Ashworth Scale, MAS) and the first secondary endpoint of Physician Global Assessment (PGA) in patients injected in different upper limb muscle groups (fingers, wrist, elbow or/and shoulder) according to patient disease presentation as Dysport® shows muscle tone reduction and clinical benefit. In addition, efficacy on active movements, spasticity, passive function and ease of applying splints was demonstrated in a statistically and clinically significant manner as compared to placebo. Efficacy was observed as early as one week post-injection and lasted up to 20 weeks in some patients.

A total of 243 patients from 34 centers were randomized to treatment with Dysport® 500U (n=80), Dysport® 1000U (n=79) or placebo (n=79). The purpose of this study was to assess the efficacy of Dysport® compared to placebo in improving Upper Limb Spasticity in hemiparetic patients following a stroke or brain trauma. The new study results published in The Lancet Neurology showed improvements on muscle tone (MAS) with mean change in MAS score from baseline at week 4 in the Primary Targeted Muscle Group was –0.3 (SD 0.6) in the placebo group, –1.2 (1.0) in the Dysport® 500 U group (p

The mean change from baseline at week 4 in Disability Assessment Scale (DAS) (passive function) for the principal target of treatment was –0.5 (0.7) in the placebo group (n=79), –0.7 (0.8) in the Dysport® 500 U group (p=0.2560 vs placebo), and –0.7 (0.7) in the Dysport® 1000 U group (p=0.0772 vs placebo). Significantly more patients receiving Dysport® 1000 U achieved reductions of 1 point or greater in the DAS for the principal target of treatment at weeks 4 and 12 than in the placebo group. These benefits persisted at week 12 (p=0.0002). In addition, this is the first large study of botulinum toxin A with a stepwise evaluation of spastic paresis, including active movements opposing targeted antagonists and spasticity measured by the Tardieu Scale. Tardieu Scale angles of catch (XV3) improved in finger, wrist and elbow flexors at week 4; the other Tardieu parameters (range of passive slow movement (XV1), spasticity angle (X) and spasticity grade (Y)) improved in some but not all cases at week 4. Active range of motion improved for movements opposing finger, wrist, and elbow flexors in the Dysport® 1000 U group and in finger flexors in the 500 U group. All those improvements in spasticity and function were accompanied by an improvement in the ease of applying splints by the patient after 4 weeks in the Dysport® groups compared with the placebo group. Dysport® was well tolerated at the two doses tested. After the completion of this double blind study, patients were offered the option to continue in an open label long-term study where they would receive additional treatment with Dysport® for a total of 15 months.

* On April 12, 2014, Ipsen has announced that a first set of results on phase III clinical study of Dysport® in the treatment of adults suffering from Upper Limb Spasticity was presented on Saturday, April 12th, at the 8th World Congress for NeuroRehabilitation in Istanbul (Turkey). Four weeks after Dysport® injection, the Phase III clinical study results demonstrated that: