Efficacy and safety study of Botulinum toxin type A against placebo to treat spasticity in the arm 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 upper limb - PURE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023043-15-DE

Enrollment

300

Registered

2011-06-07

Start date

2011-09-14

Completion date

Unknown

Last updated

2014-08-11

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 upper limb MedDRA version: 14.1 Level: LLT Classification code 10058977 Term: Spastic paresis System Organ Class: 10029205 - Nervous system disorders

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 Upper 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

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 subjects with post-stroke spasticity in the upper limb. A fixed total dose of 400 units [U] NT 201 per cycle will be injected at a fixed interval of 12 weeks between injections. ;Secondary Objective: there are no secondary objectives;Primary end point(s): Change from baseline in Ashworth Scale Score of primary target clinical pattern. Primary target clinical pattern will be defined by the investigator for each subject individually at baseline visit (week 0) and will be one of the following: flexed wrist, clenched fist or flexed elbow. Co-Primary end point: Investigator’s Global Impression of Change ;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 subjects with post-stroke spasticity in the upper limb. A fixed total dose of 400 units [U] NT 201 per cycle will be injected at a fixed interval of 12 weeks between injections. ;Secondary Objective: there are no secondary objectives;Primary end point(s): Change from baseline in Ashworth Scale Score of primary target clinical pattern. Primary target clinical pattern will be defined by the investigator for each subject individually at baseline visit (week 0) and will be one of the following: flexed wrist, clenched fist or flexed elbow. Co-Primary end point: Investigator’s Global Impression of Change ;Timepoint(s) of evaluation of this end point: Week 4

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Week 4, 8, 12;Secondary end point(s): • Response rates for the primary target clinical pattern at all post-baseline visits for subjects with an improvement (=reduction) of at least 1 point from baseline measured by the Ashworth Scale. • Response rates in each treated muscle group (elbow, wrist, and finger flexors as well as thumb muscles and forearm pronators) at all post-baseline visits for subjects with an improvement (=reduction) of at least 1 point from baseline measured by the Ashworth Scale. • Changes from baseline to all post-baseline visits in Ashworth Scale Score for each treated muscle group • Changes from baseline to all post-baseline visits in Disability Assessment Scale (primary therapeutic target and additionally all 4 items regardless of chosen primary therapeutic target)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Week 4, 8, 12;Secondary end point(s): • Response rates for the primary target clinical pattern at all post-baseline visits for subjects with an improvement (=reduction) of at least 1 point from baseline measured by the Ashworth Scale. • Response rates in each treated muscle group (elbow, wrist, and finger flexors as well as thumb muscles and forearm pronators) at all post-baseline visits for subjects with an improvement (=reduction) of at least 1 point from baseline measured by the Ashworth Scale. • Changes from baseline to all post-baseline visits in Ashworth Scale Score for each treated muscle group • Changes from baseline to all post-baseline visits in Disability Assessment Scale (primary therapeutic target and additionally all 4 items regardless of chosen primary therapeutic target)

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Countries

Czech Republic, Germany, Hungary, India, Russian Federation, United States

Outcome results

None listed

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