Status:
COMPLETED
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Post-stroke Spasticity of the Lower Limb
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 st...
Eligibility Criteria
Inclusion
- Age from 18-80 yrs
- Lower limb spasticity
- Time since stroke greater than 3 months
- Need for 400 U Botulinum toxin type A
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT01464307
Start Date
December 1 2011
End Date
May 1 2015
Last Update
November 7 2016
Active Locations (53)
Enter a location and click search to find clinical trials sorted by distance.
1
Merz Investigational Site #001184
Downey, California, United States, 90242
2
Merz Investigational Site #001208
Long Beach, California, United States, 90806
3
Merz Investigational Site #001244
Fairfield, Connecticut, United States, 06824
4
Investigational site #001188
Doral, Florida, United States, 33172