Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke

Completed · Phase 3 · Has a placebo group

Conditions studied: Post-stroke Spasticity of the Upper Limb

In brief

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.

Key facts

Study ID

NCT01392300

Run by

Merz Pharmaceuticals GmbH

People needed

317

Starts

2011-09-01

Expected to finish

2014-02-01

Last updated by the study team

2017-01-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Upper 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 upper 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 #001184 — Downey, California, United States
• Merz Investigational Site #001017 — Fountain Valley, California, United States
• Merz Investigational Site #001188 — Miami, Florida, United States
• Merz Investigational Site #001037 — Augusta, Georgia, United States
• Merz Investigational Site #001186 — Chicago, Illinois, United States
• Merz Investigational Site # 001110 — Overland Park, Kansas, United States
• Merz Investigational Site #001198 — Stratford, New Jersey, United States
• Merz Investigational Site #001240 — Chapel Hill, North Carolina, United States
• Merz Investigational Site #001009 — Winston-Salem, North Carolina, United States
• Merz Investigational Site #001241 — Philadelphia, Pennsylvania, United States
• Merz Investigational Site #001211 — Pittsburgh, Pennsylvania, United States
• Merz Investigational Site #001245 — Chattanooga, Tennessee, United States
• Merz Investigational Site #001226 — Houston, Texas, United States
• Merz Investigational Site #420046 — Brno, Czechia
• Merz Investigational Site #420029 — Brno, Czechia
• Merz Investigational Site #420028 — Olomouc, Czechia
• Merz Investigational Site #420024 — Ostrava-Poruba, Czechia
• Merz Investigational Site #420025 — Pardubice, Czechia
• Merz Investigational Site #420030 — Prague, Czechia
• Merz Investigational Site #420045 — Prague, Czechia
• Merz Investigational Site #420047 — Rychnov nad Kněžnou, Czechia
• Merz Investigational Site #049134 — Rostock, Germany
• Merz Investigational Site #036004 — Budapest, Hungary
• Merz Investigational Site # 036009 — Budapest, Hungary
• Merz Investigational Site #036005 — Nyíregyháza, Hungary

Full record on ClinicalTrials.gov

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