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

  • STATUS
    Recruiting
  • End date
    Mar 29, 2024
  • participants needed
    209
  • sponsor
    Ipsen
Updated on 21 April 2022

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 on21 April 2022

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
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
relaxants had to be stable from at least 30 days preceding the study Baseline
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
up to the Month 3 visit, and whenever possible until the end of the study
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
Likely treatment with any serotype of BoNT for any condition during the study
Known disease of the neuromuscular junction (e.g. Lambert-Eaton myasthenic syndrome
Undergone previous surgery to treat spasticity in the affected upper limb
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
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
Inability to understand protocol procedures and requirements
be maintained at the same frequency and intensity throughout the study if possible or
Infection at the injection site(s)
at least up to 3-months post-injection)
A history of drug or alcohol abuse
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
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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