Actively Recruiting
An Integrated Phase III, Multicentre, Double-blind, Randomised, Dysport and Placebo-controlled, Dose Escalation and Dose-finding Study to Evaluate the Safety and Efficacy of IPN10200 in the Treatment of Adult Upper Limb Spasticity
Led by Ipsen · Updated on 2026-05-05
240
Participants Needed
81
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying IPN10200 to evaluate its safety and effectiveness in treating adults with upper limb spasticity caused by stroke or traumatic brain injury. This integrated Phase III study aims to understand how different doses of IPN10200 affect patients and to find the doses that balance the best effects with safety. The trial is double-blind, randomized, and includes comparisons with Dysport and placebo treatments to provide thorough evaluation. The study involves several stages, starting with dose escalation where participants receive a single injection of IPN10200, Dysport, or placebo in increasing doses across groups. Later stages test two fixed doses of IPN10200 injected into various upper limb muscles. Participants are randomly assigned to different groups in ratios such as 332 or 21 depending on the stage. Each participant receives a single local injection tailored to their assigned dose group. During the trial, participants will be monitored for up to 9 months to assess safety through adverse events, vital signs, lab tests, and antibody presence. Researchers will also measure treatment effects using the Modified Ashworth Scale to evaluate muscle spasticity changes, patient and physician global assessments, pain reduction, and disability scores. Follow-up includes regular evaluations of muscle tone, treatment response timing, and overall function to understand IPN10200s impact and safety profile.
CONDITIONS
Brief Title
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 70 years inclusive (18 to 65 years for dose escalation) at consent
- Spastic hemiparesis following stroke or traumatic brain injury
- At least 6 months after stroke or traumatic brain injury
- Never received botulinum toxin or last injection at least 4 months before study baseline
- Modified Ashworth Scale score of 2 or higher in the primary target muscle group
- Eligible for a total dose of 1000 U Dysport in the upper limb if applicable
- Angle of spasticity 5 degrees or more in the primary target muscle group
- No fixed contractures defined by specific extension angles in fingers, wrist, and elbow
- Stable physiotherapy, occupational therapy, splinting, and muscle relaxants for at least 30 days before baseline and up to 3 months post-injection
- In good health without uncontrolled systemic disease or significant medical condition
- Use of contraception according to local regulations; women must not be pregnant or breastfeeding and have negative pregnancy test if applicable
You will not qualify if you...
- Any medical condition increasing risk of adverse events from botulinum toxin treatment
- Known neuromuscular junction diseases like Lambert-Eaton or myasthenia gravis
- History of hypersensitivity to study drugs or their components
- Significant psychiatric disorders interfering with study participation
- Planned or likely botulinum toxin treatment during the study
- Previous surgery for spasticity in the affected upper limb
- Physiotherapy started within 30 days prior to baseline unless stable ongoing
- Previous phenol or alcohol treatment in targeted upper limb
- Recent or planned intrathecal baclofen treatment
- Use of medications affecting neuromuscular transmission within 30 days before baseline
- Use of therapies interfering with safety or efficacy evaluation, including certain blood thinners
- Planned or recent tendon surgery, contracture, or muscle atrophy in target area
- Use of experimental drugs or devices within specified timeframes
- Other conditions increasing risk or affecting study data quality
- Pregnant or lactating women or unwilling to use effective contraception
- Inability to understand study procedures
- Infection at injection sites
- History of drug or alcohol abuse
- Male participants not vasectomised with partners of childbearing potential not using condoms with spermicide
Research Team
I
Ipsen Recruitment Enquiries
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