Status:
COMPLETED
ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb Spasticity
Lead Sponsor:
Ipsen
Conditions:
Spasticity
Eligibility:
All Genders
18-80 years
Brief Summary
The objective of this study is to evaluate the effectiveness of BoNT-A on functional improvement in patients with post-stroke upper and/or lower limb spasticity in the early stage of spasticity develo...
Eligibility Criteria
Inclusion
- Men and women ≥ 18-80 years.
- Poststroke limb spasticity.
- Patients who have suffered a stroke in the previous 6 months.
- Treatment goal has been previously agreed with the patient or their legal representative.
- Patients with clinically significant poststroke upper/lower limb spasticity, in whom it has been decided to perform multidisciplinary treatment with BoNT-A + rehabilitation.
- No previous treatment with BoNT-A.
- Patient is able to follow the protocol.
- Written informed consent.
Exclusion
- Neuromuscular disease.
- Use of drugs that interfere with neuromuscular transmission.
- Any other condition that could interfere with rehabilitation or evaluation of the results.
- Diagnosis of spasticity not associated with stroke.
- Pregnant or nursing mothers.
- Prior participation in any other study in the 6 months before study entry
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT02275312
Start Date
July 1 2014
End Date
July 1 2017
Last Update
August 16 2019
Active Locations (17)
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1
Barcelona, Spain
2
Bilbao, Spain
3
Cadiz, Spain
4
Córdoba, Spain