Efficacy and safety study of Botulinum toxin type A against placebo to treat spasticity in the leg after a stroke

Prospective, double-blind, placebo-controlled, randomized, multi-center study with 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 - PLUS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024579-23-DE

Enrollment

278

Registered

2011-09-15

Start date

2012-02-06

Completion date

Unknown

Last updated

2015-08-04

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 MedDRA version: 17.0 Level: LLT Classification code 10058977 Term: Spastic paresis System Organ Class: 100000004852

Interventions

Trade Name: Xeomin Product Name: NT 201 Product Code: NT 201 Pharmaceutical Form: Powder for solution for injection CAS Number: 93384-43-1 Current Sponsor code: NT 101 Other descriptive name: Botulinu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age from 18-80 yrs Lower limb spasticity Time since stroke greater than 3 months Need for 400 U Botulinum toxin type A Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 78

Exclusion criteria

Exclusion criteria: Body weight below 50kg Fixed contractures of the lower limb Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A Infection at the injection site

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): · Response rate for plantar flexors at all post-baseline visits for subjects with an improvement (reduction) of at least 1 point from baseline in the AS. · AS for plantar flexors at all visits and changes from baseline at all post-baseline visits.;Timepoint(s) of evaluation of this end point: Week 4, 8, 12	—

Primary

Measure	Time frame
Main Objective: To investigate the efficacy and safety of NT 201 compared to placebo in the first double-blind cycle, and in 3 subsequent open-label treatment cycles with a total exposure duration of 48 weeks in Botulinum toxin [BTX] treatment-naïve and BTX-pretreated subjects with post-stroke spasticity in the lower limb. A fixed total dose of 400 units [U] NT 201 per cycle will be injected at an interval of 12 weeks between injections.;Secondary Objective: there are no secondary objectives;Primary end point(s): Change from baseline in Ashworth Scale Score for plantar flexors;Timepoint(s) of evaluation of this end point: Week 4	—

Measure

Time frame

Main Objective: To investigate the efficacy and safety of NT 201 compared to placebo in the first double-blind cycle, and in 3 subsequent open-label treatment cycles with a total exposure duration of 48 weeks in Botulinum toxin [BTX] treatment-naïve and BTX-pretreated subjects with post-stroke spasticity in the lower limb. A fixed total dose of 400 units [U] NT 201 per cycle will be injected at an interval of 12 weeks between injections.;Secondary Objective: there are no secondary objectives;Primary end point(s): Change from baseline in Ashworth Scale Score for plantar flexors;Timepoint(s) of evaluation of this end point: Week 4

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Countries

Austria, Canada, Czech Republic, Germany, Hungary, Italy, Poland, Russian Federation, Spain, United States

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026