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Tests treatment safety and results for Spasticity
Official title A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
ClinicalTrials.gov ID: NCT04752774
What this study is testing
What is IPN10200?
IPN10200 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for spasticity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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...
- Has a MAS score ≥2 in the (PTMG) to be injected
You likely can't join if
- Any medical condition (including severe dysphagia or airway disease) that may increase, in the opinion of the investigator, the likelihood of adverse...
- 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...
- Likely treatment with any serotype of BoNT for any condition during the study.
- Undergone previous surgery to treat spasticity in the affected upper limb.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- Use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or how well it works of the study intervention, including medications affecting bleeding disorders. For...
- 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...
- 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...
- 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 the duration...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Downey, California, United States
- Overland Park, Kansas, United States
- Farmington Hills, Michigan, United States
- Elkins Park, Pennsylvania, United States
- Dallas, Texas, United States
- Innsbruck, Austria
- Linz, Austria
- Vienna, Austria
- Pleven, Bulgaria
- Rousse, Bulgaria
- Sofia, Bulgaria
- Veliko Tarnovo, Bulgaria
- Hradec Králové, Czechia
- Jihlava, Czechia
- Ostrava, Czechia
- Pardubice, Czechia
- Prague, Czechia
- Bastia, France
- Bordeaux, France
- Brest, France
+ 49 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Downey, California, United States; Overland Park, Kansas, United States; Farmington Hills, Michigan, United States; Elkins Park, Pennsylvania, United States; Dallas, Texas, United States; Innsbruck, Austria and 63 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.