J-PLUS; Japan- Post-stroke spasticity of the Lower limb study on efficacy and Safety of NT 201

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222977

Enrollment

216

Registered

2015-10-01

Start date

2015-11-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke spasticity of the lower-limb

Interventions

investigational material(s) Generic name etc : NT 201 INN of investigational material : incobotulinumtoxinA Therapeutic category code : 122 Skeletal muscle relaxants Dosage and Administration for Inve

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
safety efficacy Area Under the Curve [AUC] of the change from baseline in Modified Ashworth Scale (MAS) of plantar flexors score to the end of the Main Period From Baseline to week 12	—

Secondary

Measure	Time frame
safety efficacy Change from baseline in MAS plantar flexors score to Week 4 From Baseline to week 4	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026