A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
NCT04752774 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2026-05-05
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
- Spasticity
Interventions
- BIOLOGICAL
-
IPN10200
Powder and solvent for solution for injection
- DRUG
-
Powder and solvent for solution for injection
- BIOLOGICAL
-
Dysport
Powder for solution for injection
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Ipsen Medical Director · Ipsen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-29
- Primary Completion
- 2029-03-30
- Completion
- 2029-03-30
- FDA Drug
- Yes
Countries
- United States
- Austria
- Bulgaria
- Czechia
- France
- Germany
- Hungary
- Italy
- Japan
- Poland
- Portugal
- Russia
- South Korea
- Spain
Study Locations
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