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SpasticityETREATNCT02275312

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

An observational study of Spasticity, run by Ipsen at 17 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Spasticity
How many people
110 participants
Where
17 sitesSpain
Study dates
Jul 2014to Jul 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Post-stroke spasticity

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Spain17 sites

  • Study site

    Barcelona

  • Study site

    Bilbao

  • Study site

    Cadiz

  • Study site

    Córdoba

  • Study site

    Granada

  • Study site

    Huelva

  • Study site

    Las Palmas de Gran Canaria

  • Study site

    Lleida

  • Study site

    Madrid

  • Study site

    Murcia

  • Study site

    Palma de Mallorca

  • Study site

    Pontevedra

  • Study site

    Salamanca

  • Study site

    San Sebastián

  • Study site

    Santiago

  • Study site

    Seville

  • Study site

    Valladolid

Other trials in Spain

About this study

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.

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.

Conditions
Spasticity
Medical subject headings
Muscle Spasticity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Goal Attainment Scale (GAS) score.

    Measured: Baseline, 16 months

Secondary outcomes (11)

  1. 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

    Measured: Baseline, 16 months

  2. Change in Modified Ashworth Scale (MAS) score.

    Measured: Baseline, 16 months

  3. Baseline characteristics of patients

    Demographic characteristics

    Measured: Baseline

  4. Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score.

    Measured: From baseline up to 16 months

  5. Change in pain according to Visual Analog Scale (VAS).

    Measured: Baseline, 16 months

  6. Passive function of upper and/or lower limbs according to primary treatment target (PTT) from the disability assessment scale (DAS).

    Measured: Baseline, 16 months

  7. Comfortable barefoot walking speed, measured with the 10-meter walking speed test.

    Measured: Baseline, 16 months

  8. Change on EQ-5D quality of life questionnaire

    Measured: Baseline, 16 months

  9. Estimation of use of healthcare resources and costs associated with management of spasticity.

    Measured: From baseline up to 16 months

  10. Time interval between injections

    Measured: From baseline up to 16 months

  11. Cost per patient

    Measured: From baseline up to 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02275312
Sponsor's protocol ID
A-92-52120-192
Acronym
ETREAT
Status last verified
Aug 2019
First submitted
23 Oct 2014
Last updated
16 Aug 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spasticity, run by Ipsen at 17 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Goal Attainment Scale (GAS) score. (time frame: Baseline, 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02275312.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.

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