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Study of IPN10200 for Upper Limb Spasticity

This study is testing a new treatment called Corabotase (also known as IPN10200) for adults with upper limb spasticity (muscle stiffness) caused by a stroke or traumatic brain injury. Researchers want to see how safe and effective different doses of Corabotase are compared to a placebo (an inactive substance) or Dysport, another approved treatment. You may be able to join if you are between 18 and 70 years old and have spasticity that started at least 6 months ago. The main goals are to track any side effects and changes in your blood pressure over 9 months to find the best balance of safety and effectiveness.

Study design
This interventional study plans to include 240 participants. It compares Corabotase to a placebo and Dysport.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the start of the study until 9 months after treatment to monitor for side effects and changes in blood pressure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04752774

A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.

Recruiting
PHASE1Ages 18–70InterventionalTreatment
Ipsen
~240 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:CorabotasePlaceboDysport

At a glance

Recruiting sites
54 of 81 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants with treatment emergent adverse events (TEAEs).
Measured over From baseline until the end of study (9 months)
+6 more outcomes measured

Conditions

Spasticity

Explore related trials

SpasticityUpper limb spasticity

Where it's being run

81 sites across 18 states
Poland15
Germany8
Spain7
Czechia6
Russia6
Bulgaria5
Hungary5
Austria4

Study leadership

  • Ipsen Medical Director · STUDY_DIRECTOR · Ipsen

Who to contact

Ipsen Recruitment Enquiries
[email protected]
see email
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Complete fingers extension with Angle of arrest at slow speed (Tardieu Scale) (XV1) ≥160°
Complete wrist extension with XV1 ≥90°
Complete elbow extension with XV1 ≥160° 9. Physiotherapy, occupational therapy, splinting, use of benzodiazepine, and muscle relaxants had to be stable from at least 30 days preceding the study Baseline up to the Month 3 visit, and whenever possible until the end of the study. 10. In good health (i.e. absence of any uncontrolled systemic disease or other significant medical condition) as determined by medical history, physical and neurological examinations, clinical laboratory studies, electrocardiograms (ECGs), vital signs, and Investigator's judgment prior to randomization 11. Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

What this trial measures

  • Percentage of participants with treatment emergent adverse events (TEAEs).From baseline until the end of study (9 months)

    An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  • Percentage of participants with adverse events of special interest (AESI).From baseline until the end of study (9 months)
  • Change from baseline in vital sign parameter (blood pressure)9 months
  • Change from baseline in vital sign parameter (Heart rate)9 months
  • Change from baseline in clinical laboratory test results.9 months

    Number and percentage of participants with low, normal or high values and normal or abnormal examinations will be presented.

  • Presence of IPN10200 and BoNT-A antibodies (binding and neutralising)From baseline until the end of study (9 months)
  • Change from baseline in physical examination findings.9 months

    Number of Participants with change in physical examination findings