An Integrated Phase I/II, 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.
Ipsen
Summary
The purpose of the study is to assess the safety and efficacy of increasing doses of IPN10200 with the aim to evaluate the Pharmacodynamics (PD) profile of IPN10200 and to establish the total IPN10200 doses(s) that offer the best efficacy/safety profile when used for the treatment of Adult upper limb (AUL) spasticity.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant must be 18 to 70 years of age inclusive (except for dose escalation must be 18 to 65 years of age) at the time of signing the informed consent. 2. Has spastic hemiparesis following stroke or Traumatic brain injury (TBI) 3. Is at least 6 months post-stroke or TBI 4. Has never received BoNT or if previously treated, should have received their last injection of any commercialized BoNT-A or B at least 4 months prior to study Baseline 5. Has a MAS score ≥2 in the (PTMG) to be injected 6. Is eligible to receive a total recommended dose 1000 U Dysport in the upper…
Interventions
- BiologicalIPN10200
Powder and solvent for solution for injection
- DrugPlacebo
Powder and solvent for solution for injection
- BiologicalDysport
Powder for solution for injection
Locations (81)
- Rancho Los Amigos National RehabDowney, California
- Kansas Institute of ResearchOverland Park, Kansas
- Quest Research InstituteFarmington Hills, Michigan
- Einstein Physical Medicine and Rehabilitation at Elkins ParkElkins Park, Pennsylvania
- The University of Texas Southwestern Medical CenterDallas, Texas
- Medical University Innsbruck, Department of NeurologyInnsbruck