Status:
COMPLETED
Adult Subjects Suffering From Lower Limb Spasticity Following Stroke
Lead Sponsor:
Ipsen
Conditions:
Spasticity
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the protocol is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one botulinum toxin type-A (BoNT-A) injection cyc...
Eligibility Criteria
Inclusion
- Suffering from lower limb spasticity following stroke
- With at least a 12-week interval between the last BoNT-A injection and inclusion
- Decision already been agreed to inject BoNT-A
Exclusion
- Documented positive antigenicity to botulinum toxin
- Any neuromuscular junction indication
- Severe muscle atrophy in any muscle to be injected
- Any other indication that might interfere with rehabilitation or the evaluation of results
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01444794
Start Date
September 1 2011
End Date
February 1 2013
Last Update
November 5 2020
Active Locations (24)
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1
Hospital Maritimo de Oza
A Coruña, Spain
2
Hospital de Cruces
Barakaldo, Spain
3
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
4
Hospital de Bellvitge
Barcelona, Spain