Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merz Pharmaceuticals GmbH
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Female or male subject ≥ 18 years and ≤ 85 years at screening
Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus
Modified Ashworth Scale-Bohannon \[MAS\] score of 2 or 3 points in the ankle plantar flexor of the target lower limb (supine position, knee extended)
Minimum passive range of motion in ankle of the target lower limb (supine position, knee extended): 10°dorsiflexion and 20°plantarflexion
At least 4 months since last botulinum neurotoxin \[BoNT\] injection for treatment of spasticity or any other condition
For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an:
Activated partial thromboplastin time \[aPTT\] ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or
International normalized ratio \[INR\] value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR)
You may not be if
Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study
Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity
Body weight \< 50 kg
Severe atrophy of the target limb muscles
Previous, ongoing or planned treatments of spasticity with intrathecal baclofen
Previous, ongoing, or planned treatments of spasticity in the target lower limb with any of the following procedures: Surgical Intervention; Alcohol or phenol block; Muscle afferent block
Physiotherapy or use of orthoses or splints at the target limb initiated less than 4 weeks before screening or expected to change during the double blind phase of the study
Current or planned treatment with parenterally administered drugs that interfere with neuromuscular transmission (e.g. intrathecal baclofen, tubocurarine type muscle relaxants used in anesthesia), or local anesthetics in the treated region within 2 weeks prior to screening
Infection or inflammation at the injection sites
Subjects with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function as per investigator's clinical judgment
Pregnancy (as verified by a positive pregnancy test) or breast feeding
