Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm
Completed · Phase 3
Conditions studied: Spasticity of the Upper and Lower Limb Due to Cerebral Causes
In brief
The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.
Key facts
- Study ID
- NCT01603459
- Run by
- Merz Pharmaceuticals GmbH
- People needed
- 155
- Starts
- 2012-05-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2017-04-26
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Merz Investigational Site # 001197 — Doral, Florida, United States
- Merz Investigational Site # 001235 — Indianapolis, Indiana, United States
- Merz Investigational Site # 001191 — New York, New York, United States
- Merz Investigational Site #001238 — Charlotte, North Carolina, United States
- Merz Investigational Site # 001232 — Cleveland, Ohio, United States
- Merz Investigational Site #001237 — Milwaukee, Wisconsin, United States
- Merz Investigational Site # 001203 — Calgary, AB, Canada
- Merz Investigational site #001195 — Edmonton, AB, Canada
- Merz Investigational Site # 033018 — Garches, France
- Merz Investigational Site #033049 — Montpellier, France
- Merz Investigational Site # 033050 — Nîmes, France
- Merz Investigational Site #049191 — Aachen, Germany
- Merz Investigational Site #049297 — Bad Aibling, Germany
- Merz Investigational Site #049022 — Beelitz-Heilstätten, Germany
- Merz Investigational Site #049298 — Berlin, Germany
- Merz Investigational Site # 049153 — Giessen, Germany
- Merz Investigational Site #049295 — Göttingen, Germany
- Merz Investigational Site #049300 — Nümbrecht, Germany
- Merz Investigational Site #049296 — Tübingen, Germany
- Merz Investigational Site # 039005 — Lecco, Italy
- Merz Investigational Site # 039010 — Milan, Italy
- Merz Investigational Site # 039015 — Milan, Italy
- Merz Investigational Site # 039017 — Novara, Italy
- Merz Investigational Site #039013 — Passignano sul Trasimeno, Italy
- Merz Investigational Site #039016 — San Giovanni Rotondo, Italy
Full record on ClinicalTrials.gov
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