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: 14.0Level: LLTClassification code 10058977Term: Spastic paresisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-020886-26-ES
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-13
• Last Update Posted: 1 December 2014

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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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