Stroke and Traumatic Brain Injury are two conditions that may only happen once in your life but can have long lasting effects. Many people who have experienced either condition can suffer from partial paralysis, spasticity, dysphagia (swallowing difficulties), and other sensory issues for an extended period after the event. Here at New England Institute for Clinical Research, we are dedicated to improving the lives of those suffering from these prolonged issues.
MERZ M602011014
This study is designed to evaluate the efficacy and safety of NT 201 in individuals (18 to 85
years old) with leg spasticity due to stroke or traumatic brain injury (TBI). NT 201 works to
block the signals that tells the affected muscles to contract, thus helping to prevent the
spastic muscles from “tightening up”. The main period of the clinical trial involves one
injection cycle, where the patient either receives NT 201 (the active study drug) or placebo
for leg spasticity. The main period is followed by an open-label extension period where the
participant receives up to five injections of the definite study medication (NT 201) for
spasticity of both the leg and arm, if indicated. The duration of the study (main period and
open-label) will be at a minimum of 60 weeks to a maximum of 92 weeks.
Learn more: https://classic.clinicaltrials.gov/ct2/show/NCT03992404
Ipsen CLIN-52120-452
This study is designed to evaluate the safety and efficacy of Dysport in comparison to Botox when treating adults with arm spasticity. Both Dysport and Botox have similar mechanisms in that they work by blocking the release of acetylcholine, a chemical messenger which causes the muscles to contract. This blocking reduces the stiffness of the affected muscles and increases the range of motion. Eligible patients will have the severity of their spasticity evaluated at the beginning of the trial and will then be injected with either Dysport or Botox. The patient’s spasticity will then be continually reassessed until it
declines back to the baseline level. Once this point is reached, they will be re-injected with
the medication they did not receive in the initial injection (i.e. if first injection was Botox,
second injection would be Dysport). After the second injection, the patient’s spasticity will
again be continually reassessed until it returns to baseline levels, at which point the study
will end. Each of the two treatment cycles will be a maximum of 51 weeks each for a total
maximum study duration of 48 months (about 4 years), with in-office visits occurring about
once a month.
Learn more: https://classic.clinicaltrials.gov/ct2/show/NCT04936542
All studies and study related procedures are provided at no cost to you. There may be compensation to you for your time and travel. Participation is completely voluntary, meaning that you can withdraw at any time. If you are interested, please fill out the form below or give us a call at 203-914-1903.