Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
Completed · Phase 3 · Has a placebo group
Conditions studied: Post-stroke Spasticity of the Lower Limb
In brief
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.
Key facts
- Study ID
- NCT01464307
- Run by
- Merz Pharmaceuticals GmbH
- People needed
- 290
- Starts
- 2011-12-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2016-11-07
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age from 18-80 yrs
- Lower limb spasticity
- Time since stroke greater than 3 months
- Need for 400 U Botulinum toxin type A
You may not qualify if…
- Body weight below 50kg
- Fixed contractures of the lower limb
- 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 #001208 — Long Beach, California, United States
- Merz Investigational Site #001244 — Fairfield, Connecticut, United States
- Investigational site #001188 — Doral, Florida, United States
- Merz Investigational Site # 001110 — Overland Park, Kansas, United States
- Merz Investigational Site #001209 — Columbia, Missouri, United States
- Merz Investigational Site #001210 — St Louis, Missouri, United States
- Merz Investigational Site #001198 — Stratford, New Jersey, United States
- Merz Investigational Site #001207 — Plainview, New York, United States
- Merz Investigational Site #001009 — Winston-Salem, North Carolina, United States
- Merz Investigational Site #001206 — Nashville, Tennessee, United States
- Merz Investigational Site #001183 — Houston, Texas, United States
- Merz Investigational Site #001204 — Halifax, Nova Scotia, Canada
- Merz Investigational Site #001202 — Winnipeg, Canada
- Merz Investigational Site #420024 — Ostrava-Poruba, Czechia
- Merz Investigational Site #420031 — Ostrava-Vitkovice, Czechia
- Merz Investigational Site #420030 — Prague, Czechia
- Merz Investigational Site #420047 — Rychnov nad Kněžnou, Czechia
- Merz Investigational Site #033018 — Garches, France
- Merz Investigational Site #033024 — Rennes, France
- Merz Investigational Site #049022 — Beelitz-Heilstätten, Germany
- Merz Investigational Site #049071 — Düsseldorf, Germany
- Merz Investigational Site #049079 — Hamburg, Germany
- Merz Investigational Site #049304 — Kiel, Germany
- Merz Investigational Site #049072 — München, Germany
- Merz Investigational Site #001184 — Downey, California, United States
Full record on ClinicalTrials.gov
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