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
- Conditions
- Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
- Registration Number
- NCT03992404
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Female or male subject = 18 years and = 85 years at screening<br><br> - Diagnosis of lower limb spasticity with or without upper limb spasticity of the same<br> body side caused by stroke or traumatic brain injury<br><br> - Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus<br><br> - Modified Ashworth Scale-Bohannon [MAS] score of 2 or 3 points in the ankle plantar<br> flexor of the target lower limb (supine position, knee extended)<br><br> - Minimum passive range of motion in ankle of the target lower limb (supine position,<br> knee extended): 10°dorsiflexion and 20°plantarflexion<br><br> - At least 4 months since last botulinum neurotoxin [BoNT] injection for treatment of<br> spasticity or any other condition<br><br> - For subjects receiving anticoagulation therapy, the investigator confirms and<br> documents that the subject has an:<br><br> - Activated partial thromboplastin time [aPTT] = 80 seconds (subjects on dabigatran or<br> other direct thrombin inhibitors) or<br><br> - International normalized ratio [INR] value of = 2.5 (subjects on coumarins or other<br> anticoagulants monitored by INR)<br><br>Exclusion Criteria:<br><br> - Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert Eaton<br> syndrome, amyotrophic lateral sclerosis) or any other significant peripheral<br> neuromuscular dysfunction which might interfere with the study<br><br> - Bilateral lower limb paresis/paralysis/spasticity or<br> tetraparesis/paralysis/spasticity<br><br> - Body weight < 50 kg<br><br> - Severe atrophy of the target limb muscles<br><br> - Previous, ongoing or planned treatments of spasticity with intrathecal baclofen<br><br> - Previous, ongoing, or planned treatments of spasticity in the target lower limb with<br> any of the following procedures: Surgical Intervention; Alcohol or phenol block;<br> Muscle afferent block<br><br> - Physiotherapy or use of orthoses or splints at the target limb initiated less than 4<br> weeks before screening or expected to change during the double blind phase of the<br> study<br><br> - Current or planned treatment with parenterally administered drugs that interfere<br> with neuromuscular transmission (e.g. intrathecal baclofen, tubocurarine type muscle<br> relaxants used in anesthesia), or local anesthetics in the treated region within 2<br> weeks prior to screening<br><br> - Infection or inflammation at the injection sites<br><br> - Subjects with presence or history of aspiration pneumonia, recurrent lower<br> respiratory tract infections, or compromised respiratory function as per<br> investigator's clinical judgment<br><br> - Pregnancy (as verified by a positive pregnancy test) or breast feeding
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in derived Modified Ashworth Scale-Bohannon (MAS) ankle score (knee extended) at weeks 4 to 6;Co-Primary: Global Impression of Change Scale (GICS) assessed by physician at Week 4 to 6;Occurrence of treatment emergent adverse events [TEAEs] in the Main Period
- Secondary Outcome Measures
Name Time Method Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6;Global Impression of Change Scale (GICS) assessed by the study subject at Week 4 to 6;Global Impression of Change Scale (GICS) assessed by the caregiver at Week 4 to 6