JPRN-jRCT2080222977CompletedPhase 3
Prospective, double-blind, placebo-controlled, randomized, multi-center study with an open-label lead-in tolerability period and an open-label extension period to investigate the efficacy and safety of NT 201 in the treatment of post-stroke spasticity of the lower limb
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merz Pharmaceuticals GmbH
- Enrollment
- 219
Study Overview
Brief Summary
The study confirmed efficacy of NT 201 for lower limb spasticity. NT 201 (400 U) significantly improved the poststroke spasticity of lower 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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to <= 80age old (—)
- Sex
- All
Inclusion Criteria
- •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 50 kg.
- •-Unilateral lower-limb spasticity presenting with equinus foot deformity (condition of plantar flexion at the ankle joint) caused by a stroke at least 6 months before respective screening visit.
- •-Botulinum toxin-naive or pretreated patients with post-stroke spasticity of the LL (for pretreated subjects the last Botulinum toxin treatment must have been at least 16 weeks before the respective screening visit.
- •-Modified Ashworth Scale (MAS) score of plantar flexors at least 3.
- •-Spasticity is present in the clinical pattern pes equinus that contributes to the subject's gait impairment.
Exclusion Criteria
- •-Fixed contracture or other muscle hypertonia in the affected joint(s) intended to be treated.
- •-Bilateral lower-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.
Investigators
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