A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
Condition(s) studied
Investigational drug(s) / intervention(s)
Corabotase: Powder and solvent for solution for injection
Placebo: Powder and solvent for solution for injection
Dysport: Powder for solution for injection
Study summary
The purpose of the study is to assess the safety and efficacy of increasing doses of Corabotase (also known as IPN10200) with the aim to evaluate the Pharmacodynamics (PD) profile of Corabotase and to establish the total Corabotase doses(s) that offer the best efficacy/safety profile when used for the treatment of Adult upper limb (AUL) spasticity.
Eligibility
Primary outcome measure(s)
- 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
Trial sites (81)
| Facility | City | Region | Status |
|---|---|---|---|
| Rancho Los Amigos National Rehab | Downey | California | Recruiting |
| Kansas Institute of Research | Overland Park | Kansas | Recruiting |
| Quest Research Institute | Farmington Hills | Michigan | Terminated |
| Einstein Physical Medicine and Rehabilitation at Elkins Park | Elkins Park | Pennsylvania | Recruiting |
| The University of Texas Southwestern Medical Center | Dallas | Texas | Recruiting |
| Medical University Innsbruck, Department of Neurology | Innsbruck | Austria | Recruiting |
| Kepler University Hospital GmbH, Department of Neurology and Psychiatry | Linz | Austria | Recruiting |
| Brothers of Charity Hospital Linz, Department of Neurology I | Linz | Austria | Recruiting |
| Medical University Vienna, Department of Neurology | Vienna | Austria | Withdrawn |
| Multiprofile Hospital for Active Treatment "Heart and Brain" | Pleven | Bulgaria | Withdrawn |
| Medical Center "Rusemed" EOOD | Rousse | Bulgaria | Recruiting |
| Multiprofile Hospital for Active Treatment of Neurology and Psychiatry "Sveti Naum", Sofia, Neurological Diseases Clinic for Neurodegenerative and Peripheral Neurological Diseases | Sofia | Bulgaria | Recruiting |
| Diagnostic Consulting Center - Convex EOOD | Sofia | Bulgaria | Recruiting |
| Medical Center Medica Plus Ltd | Veliko Tarnovo | Bulgaria | Recruiting |
| University Hospital Hradec Kralove, Clinic of Neurology | Hradec Králové | Czechia | Withdrawn |
| Hospital Jihlava, Department of Neurology | Jihlava | Czechia | Recruiting |
| University Hospital Ostrava, Clinic of Neurology, Center for Demyelinating diseases | Ostrava | Czechia | Recruiting |
| Regional Hospital Pardubice, Clinic of Neurology | Pardubice | Czechia | Recruiting |
| University Hospital Kralovske Vinohrady, Clinic of Neurology | Prague | Czechia | Withdrawn |
| General University Hospital in Prague, Clinic of Neurology | Prague | Czechia | Recruiting |
| Bastia Hospital Center | Bastia | France | Not Yet Recruiting |
| Bordeaux University Hospital Center - Pellegrin Hospital Group | Bordeaux | France | Not Yet Recruiting |
| Brest University Hospital Center - Morvan Hospital | Brest | France | Not Yet Recruiting |
| Raymond-Poincare Hospital - APHP | Garches | France | Not Yet Recruiting |
| University Hospital Bonn, Clinic and Policlinic for Neurology | Bonn | Germany | Recruiting |
| Heinrich Heine University Medical Center, Department of Neurology | Düsseldorf | Germany | Terminated |
| University Medicine Goettingen, Department of Neurology | Goettigen | Germany | Withdrawn |
| University Hospital Hamburg-Eppendorf, Clinic and Polyclinic of Neurology | Hamburg | Germany | Recruiting |
| University Hospital Johannes Gutenberg - University of Mainz, Clinic and Polyclinic of Neurology | Mainz | Germany | Terminated |
| Ludwig Maximilians University Hospital, Campus Grosshadern, Department of Neurology | Munich | Germany | Withdrawn |
| GFO Clinics Troisdorf, St. Johannes Sieglar | Troisdorf | Germany | Recruiting |
| University Hospital Tuebingen, Department of Neurology | Tübingen | Germany | Recruiting |
| Semmelweis University, Rehabilitation Clinic, Rehabilitation Department of Brain Injuries | Budapest | Hungary | Recruiting |
| University of Debrecen Clinical Center, Department of Medical Rehabilitation and Physical Medicine | Debrecen | Hungary | Recruiting |
| Petz Aladar University Teaching Hospital, Department of Neurology | Győr | Hungary | Recruiting |
| Szent Damjan Greek Catholic Hospital, Department of Neurology and Stroke | Kisvárda | Hungary | Recruiting |
| Borsod-Abauj-Zemplen County Central Hospital and University Educational Hospital, Department of Neurology | Miskolc | Hungary | Recruiting |
| ASST Spedali Civili Brescia | Brescia | Italy | Recruiting |
| University Hospital "Federico II" | Naples | Italy | Not Yet Recruiting |
| University Polyclinic Foundation "Agostino Gemelli" - IRCCS | Rome | Italy | Not Yet Recruiting |
+ 41 more sites — see the full list on the official registry below.
More Ipsen trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04752774 on ClinicalTrials.gov ↗ ← All trials in South Korea