ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb Spasticity

Spasticity Clinical Trial

— ETREAT  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275312
• Other study ID #: A-92-52120-192
• Status: Completed
• Start date: July 2014
• Est. completion date: July 2017

Study information

• Verified date: August 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Goal Attainment Scale (GAS) score.		Baseline, 16 months
Secondary	Spasticity patterns will be defined in patients with upper and/or lower limb spasticity in the early stage after stroke	Descriptive statistics will be presented in addition to 95% confidence intervals for the mean and percentages	Baseline, 16 months
Secondary	Change in Modified Ashworth Scale (MAS) score.		Baseline, 16 months
Secondary	Baseline characteristics of patients	Demographic characteristics	Baseline
Secondary	Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score.		From baseline up to 16 months
Secondary	Change in pain according to Visual Analog Scale (VAS).		Baseline, 16 months
Secondary	Passive function of upper and/or lower limbs according to primary treatment target (PTT) from the disability assessment scale (DAS).		Baseline, 16 months
Secondary	Comfortable barefoot walking speed, measured with the 10-meter walking speed test.		Baseline, 16 months
Secondary	Change on EQ-5D quality of life questionnaire		Baseline, 16 months
Secondary	Estimation of use of healthcare resources and costs associated with management of spasticity.		From baseline up to 16 months
Secondary	Time interval between injections		From baseline up to 16 months
Secondary	Cost per patient		From baseline up to 16 months