Post-stroke Spasticity Lower-limb Study to Investigate Efficacy and Safety of NT 201
The PLUS study is evaluating an investigational medication for people with post-stroke spasticity of the lower limb.
Why Is PLUS Being Conducted?
Doctors estimate that approximately 19 to 38 percent of people who have had a stroke will develop spasticity in the upper and/or lower limbs. The spasticity can interfere with a person’s daily activities and recovery process, making it difficult to get through each day. Therefore, it is important to find additional treatment options for post-stroke spasticity.
Doctors in this study are testing NT 201, incobotulinumtoxinA, to see if it is able to help people experiencing post-stroke spasticity of their lower limb(s). NT 201, incobotulinumtoxinA, is manufactured Botulinum toxin type A. Although NT 201, incobotulinumtoxinA, is approved for treating other conditions, such as neurological movement disorders (dystonia), its use to treat post-stroke spasticity of the lower limb is still investigational.
Botulinum toxin, when injected into a muscle, causes localized weakening of that muscle. This partial paralysis decreases elevated muscle tone; thus, it might improve spasticity symptoms and allow for more effective physical therapy. Through this study, researchers hope to learn more about the safety and efficacy of NT 201, incobotulinumtoxinA.
Who Is Eligible to Participate in PLUS?
To pre-qualify for this study, participants must:
- Be between 18 and 80 years of age
- Have had a stroke at least three months before the start of the study
- Have medically diagnosed spasticity of the lower limb with clinical pattern pes equinovarus (see picture on the right)
- Have a need for spasticity treatment in the lower limb only
- Be able to walk at least 10 meters or 33 feet, with or without the aid of a walking stick, crutch, walker or another person
What Happens During PLUS?
People who agree to participate and are eligible will enter Part One of the study. In Part One, participants will be randomly assigned (such as by the flip of a coin) to receive an injection of either a fixed dose of NT 201, incobotulinumtoxinA, or a placebo, which looks like NT 201, incobotulinumtoxinA, but contains no active ingredients. Part One will last approximately 12 weeks and participants will only receive one injection session. If participants remain eligible after Part One, they may enter Part Two of the study and receive three injection sessions of NT 201, incobotulinumtoxinA, over a period of 36 weeks. All participants will visit the study clinic to receive injections and be evaluated by study doctors and staff members. In total, participants will make up to 14 visits to the clinic and be contacted by telephone as many as four times.
All study-related visits, tests and medication will be provided to participants at no cost. Reimbursement for travel may also be provided.
How to Participate in PLUS
Participation in the study is only possible if you visit one of the qualified investigation sites. Your eligibility to participate in the study will be assessed upon your contacting or visiting the investigation site. This decision can only be made by the physicians who have been trained for the study.
To learn more about this study or to find out if a qualified study site is reachable for you (or your patients), please go to http://clinicaltrials.gov/show/NCT01464307 or contact Merz Pharmaceuticals at firstname.lastname@example.org.