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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/05/002692

Enrollment

317

Registered

2012-05-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- post-stroke spasticity of the upper limb

Interventions

Intervention1: IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Typ

Mode of administration: intramuscular injection. Control Intervention1: Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection. : Main period: one injection session solution, prepar

Mode of administration: intramuscular injection.

Eligibility

Inclusion criteria

Inclusion criteria: • Age above and equal to 18 years to less than and equal to 80 yrs •Upper limb spasticity •Time since stroke greater than 3 months •Need for 400 U Botulinum toxin type A

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
1.Change from baseline in Ashworth Scale (AS) of the primary target clinical pattern that will be defined by investigator for each subject at basline visit and it will be either flexed wrist or clenched fist or flexed elbow. 2. Co-primary outcome measure:Investigators Global Impression of changeTimepoint: Baseline to week 4	—

Secondary

Measure	Time frame
Changes from baseline to all post-baseline visits in Ashworth Scale Score for each treated muscle group.Timepoint: Base line up to Week 48;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)Timepoint: Base line up to Week 48;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 in the AS.Timepoint: Base line up to Week 48;Response rates in each treated muscle group at all post-baseline visits for subjects with an improvement (equal to reduction)of at least 1 point from baseline measured by the AS.Timepoint: Base line up to Week 48	—

Measure

Time frame

Changes from baseline to all post-baseline visits in Ashworth Scale Score for each treated muscle group.Timepoint: Base line up to Week 48;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)Timepoint: Base line up to Week 48;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 in the AS.Timepoint: Base line up to Week 48;Response rates in each treated muscle group at all post-baseline visits for subjects with an improvement (equal to reduction)of at least 1 point from baseline measured by the AS.Timepoint: Base line up to Week 48

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Countries

Czech Republic, France, Germany, Hungary, India, Poland, Russian Federation, United States of America

Contacts

Public ContactDr Mamta Singh

Kendle India Pvt Ltd,

masingh@incresearch.com0124-4536300

Outcome results

None listed

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