A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.

Part of paid clinical trials in Downey, California.

Sponsor
Ipsen
Study ID
NCT04752774
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Spasticity

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Corabotase — BIOLOGICAL
    Powder and solvent for solution for injection
  • Placebo — DRUG
    Powder and solvent for solution for injection
  • Dysport — BIOLOGICAL
    Powder for solution for injection

Study Details

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.

Key Dates

First listed
Feb 12, 2021
Start date
Apr 29, 2021
Status verified
Jul 2026
Primary completion
Mar 30, 2029
Completion
Mar 30, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation
    One single administration of study medication (Corabotase, Dysport or placebo) will be injected in a dose-escalation manner. Dose-escalation will include several cohorts.
  • Experimental: Dose ranging
    Two fixed doses of Corabotase will be administrated as a single injection into several muscle groups of the upper limb. Participants will be randomised in the ratio of 3:3:2 (total Corabotase dose 1: 30 participants; total Corabotase dose 2: 30 participants; Dysport: 20 participants)
  • Experimental: Total dose
    One single injection of study medication will be administered locally into several muscle groups of the upper limb. Participants will be randomized in the ratio of 2:1 (Total Corabotase dose: 30 participants; placebo: 15 participants, resulting in a total of 45 participants in Stage 3). Or Participants will be randomized in the ratio of 3:1 (Corabotase lower dose: 30 participants; placebo: 10 participants, then Corabotase higher dose: 30 participants; placebo: 10 participants, resulting in a total of 80 participants in Stage 3).

Primary Outcome Measure

Percentage of participants with treatment emergent adverse events (TEAEs). [ Time Frame: From baseline until the end of study (9 months) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Rancho Los Amigos National RehabDowneyCalifornia90242-
Kansas Institute of ResearchOverland ParkKansas66211-
Quest Research InstituteFarmington HillsMichigan48334-
Einstein Physical Medicine and Rehabilitation at Elkins ParkElkins ParkPennsylvania19027-
The University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in Downey, CA

By research site
Rancho Los Amigos National Rehab· Downey, CAKansas Institute of Research· Overland Park, KSQuest Research Institute· Farmington Hills, MIEinstein Physical Medicine and Rehabilitation at Elkins Park· Elkins Park, PAThe University of Texas Southwestern Medical Center· Dallas, TX

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