J-PURE; Japan- Post-stroke spasticity of the Upper limb study on Efficacy and Safety of NT 201
- Conditions
- Post-stroke spasticity of the upper-limb
- Registration Number
- JPRN-jRCT2080222976
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
The study confirmed efficacy of NT 201 for upper limb spasticity. Both high (400 U) and low (250 U) doses of NT 201 significantly improved the poststroke spasticity of upper limb as measured using AUC of changes in MAS score after a single injection over a period of 12 weeks. The study also confirmed the favorable safety and tolerability profile of NT 201 400 U in spasticity patients. No new or unexpected safety concerns were identified.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 111
Female or male subjects from 20 to 80 (inclusive) years of age (less than 65 years during lead-in tolerability period).
-Body weight at least 40 kg.
-Unilateral upper-limb spasticity of wrist and fingers caused by a stroke at least 6 months before respective screening visit.
-Botulinum toxin-naïve or pretreated subjects with post-stroke spasticity of the upper limb. For pretreated subjects the last Botulinum toxin treatment must have been at least 16 weeks before the respective screening visit.
-Wrist flexor muscle tone is ≥ 3 and finger flexor muscle tone of at least 2 on the Modified Asworth Scale (MAS).
-At least one functional disability domain with a rating of at least 2 on the Disability Assessment Scale (DAS).
-Fixed contracture or other muscle hypertonia in the affected joint(s) intended to be treated.
-Bilateral upper-limb paresis, paralysis or tetraparesis.
-Surgery in the target limb for any indication within the 8 weeks before screening or within the screening period.
-Any previous and planned surgical treatment for spasticity in the target muscle(s).
-Severe atrophy of the target limb muscles.
-Any previous or planned treatment with phenol- or alcohol-injection into the target limb, as well as any planned treatment with phenol- or alcohol-injection in any body region scheduled for any time during the study.
-Treatment with parenterally administered drugs that interfere with neuromuscular transmission, aminoquinolines, or local anesthetics in the treated region within the two weeks before screening, within the screening period, and/or intended to be administered during the study.
-Antispastic medication with peripheral muscle relaxants administered within the two weeks before screening, within the screening period, or intended to be administered during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method