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A study investigating single injection of new botulinum toxin to determine safety and efficacy for treating spasticity in the upper limb
EU CTIS ID: 2023-507202-14-00
What this study is testing
Stage 1: To assess the safety and tolerability of increasing doses of a single treatment of IPN10200 in participants’ in the PTMG compared with Dysport and placebo, and to select two dose levels for further investigation in Stage 2. Stage 2: To determine the safety of two doses of IPN10200 selected after Stage 1, for the treatment of AUL spasticity in participants in the PTMG (mandatory of the two permitted clinical patterns in Stage 2) compared with Dysport at the peak of treatment effect, and to select the lowest dose which is safe and effective and providing required duration of response for the further investigation in Stage 3. Open-label extension period: To determine the safety of IPN10200 for the treatment of AUL spasticity in participants from Stage 3 with several clinical patterns over multiple treatment cycles. Stage 3: To assess the efficacy of IPN10200 compared to placebo for the treatment of AUL spasticity in participants in the PTMG (mandatory clinical pattern in Stage 3)
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 consent.
- 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 judgement prior to randomisation
- 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: 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. • Female participants: o 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 WOCBP and using an acceptable contraceptive method during the study intervention period (at a minimum until after the last dose of study intervention). The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention. o A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and protocol.
- Has spastic hemiparesis following stroke or TBI
- Is at least 6 months post-stroke or TBI
You likely can't join if
- Any medical condition (including, but not limited to: severe dysphagia or airway disease, severe impairment of ability to walk (e.g. wheelchair-bound) and/or living in long-term care facilities due to loss of autonomy) that may increase, in the opinion of the investigator, the likelihood of adverse events related to BoNT treatment.
- 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.
- 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.
See the full eligibility criteria
Who can join
- 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.
- 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 judgement prior to randomisation
- 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: 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. • Female participants: o 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 WOCBP and using an acceptable contraceptive method during the study intervention period (at a minimum until after the last dose of study intervention). The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention. o A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and protocol.
- Has spastic hemiparesis following stroke or 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 commercialised 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
- Has the angle of arrest as measured by the Tardieu scale (XV1) in the muscle groups to be injected as follows: • XV1 ≥160° for finger flexors • XV1 ≥90° for wrist flexors • XV1 ≥160° for elbow flexors
- Stage 1 and 2: 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. Stage 3: Physiotherapy, occupational therapy, splinting, use of benzodiazepine, and muscle relaxants had to be stable from at least 3 months preceding the study Baseline up to the Month 3 visit, and whenever possible until the end of the study.
What rules you out
- Any medical condition (including, but not limited to: severe dysphagia or airway disease, severe impairment of ability to walk (e.g. wheelchair-bound) and/or living in long-term care facilities due to loss of autonomy) that may increase, in the opinion of the investigator, the likelihood of adverse events related to BoNT treatment.
- 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.
- 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 judgement 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 and for the duration of the study.
- 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.