The medical director of the New England Institute for Neurology and Headache and chief medical officer of the New England Institute for Clinical Research detailed the end points and long-term goals of the phase 2 JUNIPER upper limb spasticity trial.
“In my opinion, this is the biggest new advance in neurotoxin research in the last 2 decades, and that’s very important.”
The phase 2 JUNIPER clinical trial of daxibotulinumtoxinA injection for the treatment of upper limb spasticity in adults following stroke or traumatic brain injury recently completed the enrollment of 76 patients between the age of 18 to 75 years old. Patients within the study will be randomized into 1 of 4 treatment groups: low dose, medium doses, high dose and a placebo.
JUNIPER will last 36 weeks, with change from baseline in muscle group most severely affected by spasticity score at Week 6 and change from Baseline Physician Global Impression of Change score at Week 6 as the 2 primary end points. Peter McAllister, MD, medical director, New England Institute for Neurology and Headache, and chief medical officer, New England Institute for Clinical Research, is among the lead investigators of the trial. He noted that he feels as though this trial carries a lot of weight considering the lack of post-stroke upper limb spasticity treatments.
He discussed the trials in entirety with NeurologyLive, as well as the long-term potential of daxibotulinumtoxinA if proven successful, and how he views the landscape of post-stroke upper limb spasticity treatments.