Trials / Recruiting
RecruitingNCT04752774
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
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.
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- Sponsor
- Ipsen · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IPN10200 | Powder and solvent for solution for injection |
| DRUG | Placebo | Powder and solvent for solution for injection |
| BIOLOGICAL | Dysport | Powder for solution for injection |
Timeline
- Start date
- 2021-04-29
- Primary completion
- 2027-10-30
- Completion
- 2027-10-30
- First posted
- 2021-02-12
- Last updated
- 2026-04-06
Locations
81 sites across 14 countries: United States, Austria, Bulgaria, Czechia, France, Germany, Hungary, Italy, Japan, Poland, Portugal, Russia, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04752774. Inclusion in this directory is not an endorsement.