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

  • STATUS
    Recruiting
  • End date
    Mar 29, 2024
  • participants needed
    209
  • sponsor
    Ipsen
Updated on 24 September 2021

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.

Details
Condition Spasticity
Treatment Placebo, Dysport, IPN10200
Clinical Study IdentifierNCT04752774
SponsorIpsen
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

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
Complete fingers extension with Angle of arrest at slow speed (Tardieu Scale) (XV1) 160
Complete wrist extension with XV1 90
Complete elbow extension with XV1 160
Physiotherapy, occupational therapy, splinting, use of benzodiazepine, and muscle relaxants had to be stable from at least 30 days preceding the study Baseline up to the Month 3 visit, and whenever possible until the end of the study
In good health (i.e. absence of any uncontrolled systemic disease or other significant medical condition) as determined by medical history, physical and neurological examinations, clinical laboratory studies, electrocardiograms (ECGs), vital signs, and Investigator's judgment prior to randomization
Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Male participants must agree that, if their partner is at risk of becoming
pregnant, they will use an effective method of contraception. The participants
must agree to use the contraception during the whole period of the study and
for 12 weeks after injection of study intervention
A female participant is eligible to participate if she is not pregnant or
breastfeeding, and one of the following conditions applies: Is a woman of non-
childbearing potential (WONCBP) or is a woman of childbearing potential
(WOCBP) and using an acceptable contraceptive method (at a minimum until after
the last dose of study intervention). The investigator should evaluate the
potential for contraceptive method failure in relationship to the first dose
of study intervention. A WOCBP must have a negative highly sensitive pregnancy
test

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
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
Has been treated or is likely to be treated with intrathecal baclofen during the 30 days prior to study Baseline or during the course of the study
Current or planned treatment with any medications that interfere either directly or indirectly with neuromuscular transmission, such as curare-like non depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within 30 days prior to Baseline
Use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study intervention, including medications affecting bleeding disorders, provided the International normalized ratio (INR) is controlled between 2 and 3 (antiplatelet agents and/or anticoagulants given for treatment or prevention of cardiovascular/cerebrovascular diseases)
Currently planned or a history of tendon lengthening surgery, significant contracture or muscle atrophy at target joint or muscle in the past 6 months prior to Screening
Use of any experimental device within 30 days or use of any treatment with an experimental drug within five times the documented terminal half-life of the respective drug or its metabolites or if the half-life is unknown within 30 days prior to the start of the study (prior to Baseline) and during the conduct of the study
Presence of any other condition (e.g. neuromuscular disorder, muscular dystrophies, cancer cachexia, sarcopenia or other disorder that could interfere with neuromuscular function), laboratory finding or circumstance that, in the judgment of the investigator, might increase the risk to the participant or decrease the chance of obtaining satisfactory data to achieve the objectives of the study
Pregnant or lactating women, or women of childbearing potential not willing to practice a highly effective form of contraception method at the beginning of the study, for the duration of the study and for a minimum of 12 weeks following last administration of study treatment
Inability to understand protocol procedures and requirements
Infection at the injection site(s)
A history of drug or alcohol abuse
Male participants who are not vasectomised and who have female partners of childbearing potential and are not willing to use condoms with spermicide throughout study participation for a minimum of 12 weeks following initial double-blind administration of study Intervention
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