A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spast… (NCT04752774) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
United States240 participantsStarted 2021-04-29
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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
✓. Has a MAS score ≥2 in the (PTMG) to be injected
✓. Is eligible to receive a total recommended dose 1000 U Dysport in the upper limb when applicable.
✓. Has angle of spasticity ≥5° in the PTMG to be injected.
✓. Does not have any fixed contractures as defined by:
Exclusion criteria
✕. 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.
What they're measuring
1
Percentage of participants with treatment emergent adverse events (TEAEs).
Timeframe: From baseline until the end of study (9 months)
2
Percentage of participants with adverse events of special interest (AESI).
Timeframe: From baseline until the end of study (9 months)
3
Change from baseline in vital sign parameter (blood pressure)
Timeframe: 9 months
4
Change from baseline in vital sign parameter (Heart rate)
Timeframe: 9 months
5
Change from baseline in clinical laboratory test results.
Timeframe: 9 months
6
Presence of IPN10200 and BoNT-A antibodies (binding and neutralising)
Timeframe: From baseline until the end of study (9 months)
7
Change from baseline in physical examination findings.
. 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.
✕. Likely treatment with any serotype of BoNT for any condition during the study.
✕. Undergone previous surgery to treat spasticity in the affected upper limb.
✕. Has initiated physiotherapy within 30 days prior to Baseline (if physiotherapy initiated more than 30 days prior to Baseline and ongoing, the therapy regimen should be maintained at the same frequency and intensity throughout the study if possible or at least up to 3-months post-injection).
✕. Has received previous treatment with phenol and or alcohol in the targeted upper limb any time before the study.