ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb Spasticity
ETREAT
ETREAT: A Prospective Observational Study to Evaluate the Effectiveness of Botulinum Toxin Type A (BoNT-A) Injections in Patients With Post-stroke Upper and/or Lower Limb Spasticity in the Early Stage of Spasticity Development.
1 other identifier
observational
110
1 country
17
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 development, according to routine clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2014
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 23, 2014
CompletedFirst Posted
Study publicly available on registry
October 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedAugust 16, 2019
August 1, 2019
3 years
October 23, 2014
August 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Goal Attainment Scale (GAS) score.
Baseline, 16 months
Secondary Outcomes (11)
Spasticity patterns will be defined in patients with upper and/or lower limb spasticity in the early stage after stroke
Baseline, 16 months
Change in Modified Ashworth Scale (MAS) score.
Baseline, 16 months
Baseline characteristics of patients
Baseline
Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score.
From baseline up to 16 months
Change in pain according to Visual Analog Scale (VAS).
Baseline, 16 months
- +6 more secondary outcomes
Eligibility Criteria
Post-stroke spasticity
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (17)
Unknown Facility
Barcelona, Spain
Unknown Facility
Bilbao, Spain
Unknown Facility
Cadiz, Spain
Unknown Facility
Córdoba, Spain
Unknown Facility
Granada, Spain
Unknown Facility
Huelva, Spain
Unknown Facility
Las Palmas de Gran Canaria, Spain
Unknown Facility
Lleida, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Murcia, Spain
Unknown Facility
Palma de Mallorca, Spain
Unknown Facility
Pontevedra, Spain
Unknown Facility
Salamanca, Spain
Unknown Facility
San Sebastián, Spain
Unknown Facility
Santiago, Spain
Unknown Facility
Seville, Spain
Unknown Facility
Valladolid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2014
First Posted
October 27, 2014
Study Start
July 1, 2014
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
August 16, 2019
Record last verified: 2019-08