Monitoring for Post-Stroke Spasticity

(EPITOME Trial)

Recruiting at 55 trial locations

Overseen By Ipsen Clinical Study Enquiries

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ipsen

Disqualifiers: Neurological impairment, Cardiac disease, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

1051 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how often people develop spasticity (muscle stiffness) after their first-ever stroke. The goal is to create a standard guide for doctors to monitor this condition effectively. Individuals who experienced a stroke with lasting weakness in their arms or legs might be suitable candidates. The study will help identify those who could benefit from medication to treat spasticity. Participants must be able to give consent and meet the study's criteria. As an unphased study, this trial offers participants the chance to contribute to important research that could enhance post-stroke care for future patients.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to establish a clear guideline for monitoring post-stroke spasticity, which currently lacks a standardized approach. This trial could lead to improved early detection and management of spasticity, ensuring that patients receive timely and more effective interventions. By identifying how often spasticity occurs and providing a consistent monitoring protocol, healthcare providers can better tailor treatment plans, ultimately enhancing patient outcomes and quality of life.

Who Is on the Research Team?

Ipsen Medical Director

Principal Investigator

Ipsen

Are You a Good Fit for This Trial?

Inclusion Criteria

You have suffered a first-ever clinical stroke, meeting the World Health Organization's stipulations for symptoms of focal or global impairment to cerebral function lasting 24 hours or more within the past 4 weeks.

You have experienced long-lasting weakness in one or both limbs, as evidenced by a score of greater than zero on questions five and six of the NIHSS scale which persists for at least two weeks following your stroke.

You are capable of providing consent to the conditions outlined in both the Informed Consent Form and this protocol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Monitoring

Participants are monitored for the development of post-stroke spasticity

12 months

Visits at Week 2, Month 1, Month 2, and every 3 months up to Month 12

Clinical Confirmation Visit (CCV)

Assessment of spasticity and determination of need for pharmacological therapy

Up to 18 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main monitoring phase

2 months

Visits every 3 months up to Month 14

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

Ipsen

Lead Sponsor

Trials

358

Recruited

74,600+

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD