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

Conditions: Spasticity of the upper and lower limb of the same body side due to cerebral causes
MedDRA version: 17.1Level: LLTClassification code 10058977Term: Spastic paresisSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2010-020886-26-PT

Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

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

-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>Occurence of treatment-emergent AEs, AESIs and SAEs related to the administration of study medication by injection cycle<br><br>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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Ashworth Scale (AS) of the target joint selected at study baseline visit<br><br>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<br><br>Resistance to passive movement scale (REPAS)<br><br>Functional ambulation classification (FAC) scale<br><br>Global attainment scale (GAS) for upper and lower limb, respectively<br><br>Disability Assessment Scale (DAS) in a selected principal therapeutic target domain affecting the upper limb<br><br>EuroQoL 5-dimensional questionaire (EQ-5D)<br><br>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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