A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
ConditionSpasticity
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIpsen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Has spastic hemiparesis following stroke or Traumatic brain injury (TBI)
Is at least 6 months post-stroke or TBI
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
Disqualifiers
Any medical condition (including severe dysphagia or airway disease) that may increase, in the opinion of the investigator, the likelihood of adverse events (AEs) related to BoNT treatment.
Known disease of the neuromuscular junction (e.g. Lambert-Eaton myasthenic syndrome, myasthenia gravis or amyotrophic lateral sclerosis etc.).
Has a history of hypersensitivity to the investigational medicinal products (or other BoNTs) or any excipient used in their formulation.
Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the participant's participation in the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Corabotase
Biological/VaccinePowder and solvent for solution for injection
Placebo
DrugPowder and solvent for solution for injection
Dysport
Biological/VaccinePowder for solution for injection
Treatment groups
240 Participants
are divided into 3 treatment groupsGroup A: Dose escalationExperimental treatment 3 interventions
Group B: Dose rangingExperimental treatment 2 interventions
Group C: Total doseExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of participants with treatment emergent adverse events (TEAEs).
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame
From baseline until the end of study (9 months)2
Percentage of participants with adverse events of special interest (AESI).
Time frame
From baseline until the end of study (9 months)3
Change from baseline in vital sign parameter (blood pressure)
Time frame
9 months4
Change from baseline in vital sign parameter (Heart rate)
Time frame
9 monthsSecondary outcomes
1
Change from Baseline to all post-treatment visits in Modified Ashworth scale (MAS) score in the Primary target muscle group (PTMG)
MAS is a scale to assess muscle tone in the injected muscles. The muscle tone will be rated as per grading from 0 to 4, there 0 =No increase in muscle tone and 4 =Affected part(s) rigid in flexion or extension.
Time frame
from baseline until the end of study (9 months)2
Change from Baseline to post-treatment Day 29 in MAS score in the PTMG.
If PD profile of IPN10200 in dose escalation indicates a peak of effect different than Day 29, the endpoint will be modified accordingly)
Time frame
From baseline until post-treatment Day 293
Change from Baseline in MAS score in all injected muscle Groups
Time frame
From baseline until the end of study (9 months)4
Time to onset - time to the response to treatment (a reduction of at least one grade in the MAS score).
Time frame
From baseline until the end of study (9 months) Source ClinicalTrials.gov