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Spasticity as Sequela of StrokeEPITOMENCT06055725

A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development

An observational study of Spasticity as Sequela of Stroke, run by Ipsen at 55 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will monitor patients during the first year following their stroke. Stroke is a very serious condition where there is a sudden interruption of blood flow in the brain. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Spasticity as Sequela of Stroke
How many people
1,057 participants
Where
55 sitesin 7 countries
Study dates
1 Nov 2023to 30 Nov 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The Main Population will be participants aged 18 to 90 years with confirmed paresis within 2 weeks after a first-ever clinical stroke that has occurred within the past 4 weeks

Who may be able to join

  • Participant must be aged 18 to 90 years at the time of providing informed consent
  • First-ever clinical stroke, defined according to World Health Organization criteria as rapidly developing clinical signs of focal (at times global) disturbance of cerebral function lasting more than 24 hours, within the past 4 weeks;
  • Confirmed paresis of the arms and/or legs which does not resolve within 1 day, according to the NIHSS score (a score of > 0 on Question 5 or 6 of the scale) within 2 weeks after the stroke
  • Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

Who cannot join

  • Upper or lower extremity functional impairment prior to stroke per investigator judgement (e.g., modified Rankin Scale >2);
  • Presence of significant/major neurological impairment that might affect muscle tone (other than limb paresis);
  • Severe multi-impairment or diminished physical condition before stroke that could have caused paresis/spasticity/motor deficit per investigator judgement;
  • Life expectancy of less than 12 months as a result of severity of stroke or other illnesses (e.g. cardiac disease, malignancy, etc.)
  • Participation in any interventional study

Trial locations and contacts

55 sites in 7 countries.

55 sites in 7 countries

United States17 sites

  • Loma Linda

    Anderson, California, 92354

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Spaulding Rehabilitation Hospital

    Boston, Massachusetts, 02129

  • Dayton Center for Neurological Disorders

    Centerville, Ohio, 45459

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Missouri Health Care

    Columbia, Missouri, 65212

  • The University Of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8869

  • Duke University School of Medicine

    Durham, North Carolina, 27705

  • Moss Rehab

    Elkins Park, Pennsylvania, 19027

  • McGovern Medical School - UT Physicians - Neurology (Adult Neurology Clinic) - Texas Medical Center Location

    Houston, Texas, 77030

  • Medstar Health Research Institute, Inc

    Hyattsville, Maryland, 20782

  • Las Vegas Neurology Center

    Las Vegas, Nevada, 89106

  • Medical College of Wisconsin

    Milwauke, Wisconsin, 53226

  • Methodist Physicians Clinic

    Omaha, Nebraska, 68114

  • Madonna Rehabilitation Hospital - Omaha Campus

    Omaha, Nebraska, 68118

  • Knight Neurology

    Rockledge, Florida, 32955

  • University Of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

Germany9 sites

  • Klinikum Altenburger Land GmbH

    Altenburg

  • Charité - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

    Berlin, 10117

  • University Hospital Carl Gustav Carus

    Dresden

  • Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)

    Düsseldorf

  • Universitaetsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel

    Kiel, 24105

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck

    Lübeck, 23562

  • Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz

    Mainz, 55131

  • Universitaetsklinikum Tuebingen (UKT)

    Tübingen

Other trials in Germany

Spain8 sites

  • Hospital Universitari Germans Trias i Pujol (HUGTP)

    Badalona

  • Hospital Mutua De Terrassa

    Barcelona, 08221

  • Hospital Clinic i Provincial

    Barcelona

  • Hospital Universitario La Paz

    Madrid, 28046

  • Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa

    Madrid

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Complexo Hospitalario Universitario De Vigo - Hospital Do Mexoeiro

    Vigo, 36200

  • Hospital Universitario Miguel Servet de Zaragoza

    Zaragoza

Other trials in Spain

Italy7 sites

  • Azienda Ospedaliero Universitaria OO RR di Foggia

    Foggia, 71100

  • Ospedal Valduce

    Lecco, 23845

  • Milan University, Humanitas Clinical Institute

    Milan

  • AOU maggiore della Carita'

    Novara, 28100

  • AOU San giovanni di Dio e Ruggi d'aragona Univ. di Salerno

    Salerno, 84131

  • Neurological Rehabilitation Unit- Policlinico Borgo Roma.

    Verona, 37134

  • Neuromotor And Cognitive Rehabilitation Research Centre; Dep. Of Neurological, Neuropsychological, Morphological And Movement Sciences; Univ. Of Verona - Neurological Rehabilitation Unit- Policlinico Borgo Roma

    Verona

Other trials in Italy

France5 sites

  • CHU Bordeaux-Hopital Pellegrin

    Bordeaux, 33076

  • CHU de Caen

    Caen, 14033

  • CHU de Rennes, Hopital de Pontchaillou

    Rennes, 35033

  • Hospices Civils de Lyon (HCL) - Hopital Henry Gabrielle

    Saint-Genis-Laval, 69230

  • CHU Nantes

    Saint-Jacques

Other trials in France

United Kingdom5 sites

  • University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)

    Leicester, LE5 4PW

  • The Walton Centre

    Liverpool

  • Kings College Hospital NHS Foundation Trust

    London

  • South Tees Hospitals Foundation Nhs Trust

    Middlesbrough

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    Nottingham

Other trials in United Kingdom

Sweden4 sites

  • Angelholm Northern Hospital

    Ängelholm, 26281

  • Sodra Alvsborgs Sjukhus

    Borås, 50455

  • Skane University Hospital

    Malmö, 20502

  • Karnsjukhuset Skaraborg

    Skövde, 54185

Other trials in Sweden

About this study

Official title: A Prospective, Multicountry Study to Estimate the Incidence of and Provide a Best Practice Model for Monitoring the Development of Post-Stroke Spasticity

This study will monitor patients during the first year following their stroke.

Stroke is a very serious condition where there is a sudden interruption of blood flow in the brain.

The main aim of the study will be to find out how many of those who experience their first-ever stroke then go on to develop spasticity that would benefit from treatment with medication.

Spasticity is a common post-stroke condition that causes stiff or ridged muscles.

The results of this study will provide a standard guideline on the best way to monitor the development of post-stroke spasticity.

What is being measured

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

  1. Percentage of participants at the Clinical Confirmation Visit (CCV) who have problematic spasticity and who the investigator considers would benefit from pharmacological therapy

    This is based on the investigator's clinical judgement and could include spasticity characterised by any of the following criteria aligned with the World Health Organization International Classification of Functioning, Disability and Health in three dimensions: Impairment, Activity limitations \& Restriction on participation.

    Measured: At the Clinical Confirmation Visit (CCV) up to maximum 18 months

Secondary outcomes (17)

  1. Distribution of National Institutes of Health Stroke Scale (NIHSS) scores

    Including description of score for each physical item (arm and leg motor scores) and total physical item score National Institutes of Health Stroke Scale (NIHSS) is a 15-item impairment scale, intended to evaluate neurologic outcome and degree of recovery for patients with stroke. The scale assesses level of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect) (Lyden, Lu, \& Jackson, 1999; Lyden, Lu, \& Levine, 2001). The higher the NIHSS score the worse the outcome for the participant. If the participant has a score greater than '0' they will satisfy Inclusion Criteria number 3.

    Measured: At enrollment

  2. Percentage of participants who develop signs of possible spasticity

    Measured: At Week 2, Month 1, Month 2, and every 3 months up to Month 12.

  3. Percentage of participants who develop clinically confirmed spasticity

    Measured: Week 2 to Month 14

  4. Time from first ever stroke to detection of signs of possible spasticity

    Measured: Week 2 to Month12

  5. Time from first ever stroke to onset of clinically confirmed spasticity

    Measured: Week 2 to Month 14

  6. Time from first-ever stroke to onset of clinically confirmed problematic spasticity

    Measured: Week 2 to Month 18

  7. Description of signs of possible spasticity from the Post-stroke Spasticity Monitoring Questionnaire (PSMQ)

    Post-stroke Spasticity Monitoring Questionnaire (PSMQ) is a modified version (in local language) of a published 13-item patient reported screening questionnaire designed as a practical, easy-to-use tool to enable health care providers to identify patients with spasticity in need of treatment in routine clinical practice. The PSMQ will have an additional (14th) question for the participant to answer only if he/she has a total score for the first 13 questions of > 0 and has given an identical pattern of responses for any previously answered questionnaire which led to a F2F visit where a result of Modified Ashworth Scale (MAS) = 0 was obtained. The higher the PSMQ or MAS score is the worse the outcome for the participant.

    Measured: At Week 2, Month 1, Month 2, and every 3 months up to Month 12.

  8. MAS distribution at the CCV (overall and distribution by timing post-stroke)

    Measured: Week 2 to Month 14

  9. Distribution of spasticity (arm/leg, unilateral/bilateral, affected muscle groups) at the CCV

    Measured: Week 2 to Month 14

  10. Severity of spasticity by Modified Ashworth Scale (MAS) at the CCV

    Measured: Week 2 to Month 14

  11. MAS distribution (overall and distribution by timing post stroke) at the CCV

    MAS score per joint/muscle group and MAS total score by limb

    Measured: At Week 2, Month 1, Month 2, and every 3 months up to Month 14.

  12. MAS distribution of problematic spasticity at the CCV (overall and distribution by timing post-stroke)

    Measured: Week 2 to Month 18

  13. Distribution of problematic spasticity (arm/leg, unilateral/bilateral, affected muscle groups) Severity of problematic spasticity by MAS at the CCV

    Measured: Week 2 to Month 18

  14. Distribution of 36-Item Short-form Health Survey (SF-36) quality of life questionnaire scores in participants with clinically confirmed spasticity[c] at the CCV

    Participants with clinically confirmed spasticity (MAS > 0 in any muscle group of arm and/or leg) at the CCV will be asked to complete the SF-36 health survey to assess their general health and wellbeing. The SF-36 is a generic, multipurpose short form survey consisting of 36 questions. Most of the questions are answered based on how the participant has been feeling over the previous 4 weeks.

    Measured: Week 2 to Month 14

  15. Percentage of participants who develop problematic spasticity at the time of the confirmed diagnosis of spasticity at CCV

    Measured: Week 2 to Month 14

  16. Percentage of participants who develop problematic spasticity

    Measured: At CCV and 4 months after the CCV

  17. Stroke types

    In terms of side (Left/Right), aetiology (Ischaemic/Haemorrhagic), and Bamford/Oxford classification (Total Anterior Circulation (TAC), Partial Anterior Circulation (PAC), Lacunar syndrome (LAC), Posterior Circulation syndrome (POC), occurrence of thrombolysis or thrombectomy.

    Measured: Week 2 to Month 14

Timeline

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

  1. First posted28 Sep 2023
  2. Study start1 Nov 2023
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

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
Cohort
Time perspective
Prospective
Enrolment
1,057 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06055725
Sponsor's protocol ID
CLIN-52120-458
Acronym
EPITOME
Status last verified
Sep 2026
First submitted
20 Sep 2023
Last updated
4 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Publications

  • Zorowitz RD, Barrenechea LS, Butet S, Groppa S, Hernandez Herrero D, Prasad R, Sandars S, Meloni S, Page S, Maisonobe P, Picelli A. How many stroke survivors develop problematic spasticity requiring pharmacological therapy? An international (Europe and USA) observational study protocol. BMJ Open. 2025 Jan 15;15(1):e087404. doi: 10.1136/bmjopen-2024-087404.

    PubMed 39819949

Questions about this trial

What is this clinical trial studying?

An observational study of Spasticity as Sequela of Stroke, run by Ipsen at 55 sites in 7 countries.

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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Germany, Spain, Italy, France and 2 more countries. 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?

This study is still under way. Results are not available in the source record yet.

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?

Percentage of participants at the Clinical Confirmation Visit (CCV) who have problematic spasticity and who the investigator considers would benefit from pharmacological therapy (time frame: At the Clinical Confirmation Visit (CCV) up to maximum 18 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 NCT06055725, which also lists 1 linked publication.

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 4 Sep 2026.

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