Dose titration study to evaluate efficacy and safety of Botulinum toxin type A to treat spasticity in the leg and arm

Prospective, open-label, non-randomized, single-arm, multi-center dose titration study to investigate the safety and efficacy of NT 201 in subjects deemed to require total body doses of 800 U of NT 201 during the course of the study for the treatment of upper and lower limb spasticity of the same body side due to cerebral causes - TOWER

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020886-26-DE

Enrollment

150

Registered

2011-10-05

Start date

2011-12-15

Completion date

Unknown

Last updated

2015-10-26

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

Conditions

Spasticity of the upper and lower limb of the same body side due to cerebral causes 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 - Upper and lower limb spasticity of the same body side due to cerebral causes - Time since event leading to spasticity in the target body side greater than 12 weeks - Need for 800 units 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 target joint - 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: The primary objective of this clinical study is to assess the safety of doses of NT 201 of up to 800 U in subjects suffering from spasticity in both upper and lower limbs of the same side of the body due to cerebral causes over a period of up to 48 weeks with flexible injection intervals of 12 to 16 weeks.;Secondary Objective: As a secondary objective, this study will evaluate the impact of the administration of NT 201 on several efficacy variables.;Primary end point(s): Occurence of treatment emergent adverse events (AEs), AEs of special interest (AESIs), and Serious AEs (SAEs) by injection cycle Occurence of treatment-emergent AEs, AESIs and SAEs related to the administration of study medication by injection cycle Investigator's global assessment of tolerability using a 4-point Likert scale at end of injection cycle visits;Timepoint(s) of evaluation of this end point: week 12-16, week 24-32, week 36-48	—

Measure

Time frame

Main Objective: The primary objective of this clinical study is to assess the safety of doses of NT 201 of up to 800 U in subjects suffering from spasticity in both upper and lower limbs of the same side of the body due to cerebral causes over a period of up to 48 weeks with flexible injection intervals of 12 to 16 weeks.;Secondary Objective: As a secondary objective, this study will evaluate the impact of the administration of NT 201 on several efficacy variables.;Primary end point(s): Occurence of treatment emergent adverse events (AEs), AEs of special interest (AESIs), and Serious AEs (SAEs) by injection cycle Occurence of treatment-emergent AEs, AESIs and SAEs related to the administration of study medication by injection cycle Investigator's global assessment of tolerability using a 4-point Likert scale at end of injection cycle visits;Timepoint(s) of evaluation of this end point: week 12-16, week 24-32, week 36-48

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Secondary

Measure	Time frame
Secondary end point(s): Ashworth Scale (AS) of the target joint selected at study baseline visit AS of every joint affected by clinical patterns of spasticity and treated at least once, of the same body side as the selected target joint Resistance to passive movement scale (REPAS) Functional ambulation classification (FAC) scale Global attainment scale (GAS) for upper and lower limb, respectively Disability Assessment Scale (DAS) in a selected principal therapeutic target domain affecting the upper limb EuroQoL 5-dimensional questionaire (EQ-5D) Global assessment of efficacy;Timepoint(s) of evaluation of this end point: from baseline up to week 48 for: AS, REPAS, FAC, DAS,EQ-5D. Up to week 48 for: GAS and Global assessment of efficacy	—

Measure

Time frame

Secondary end point(s): Ashworth Scale (AS) of the target joint selected at study baseline visit AS of every joint affected by clinical patterns of spasticity and treated at least once, of the same body side as the selected target joint Resistance to passive movement scale (REPAS) Functional ambulation classification (FAC) scale Global attainment scale (GAS) for upper and lower limb, respectively Disability Assessment Scale (DAS) in a selected principal therapeutic target domain affecting the upper limb EuroQoL 5-dimensional questionaire (EQ-5D) Global assessment of efficacy;Timepoint(s) of evaluation of this end point: from baseline up to week 48 for: AS, REPAS, FAC, DAS,EQ-5D. Up to week 48 for: GAS and Global assessment of efficacy

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Countries

Canada, Germany, Italy, Portugal, Spain, United States

Outcome results

None listed

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