EUCTR2020-003623-42-BG进行中（未招募）1 期
An Integrated Phase I/II, Multicentre, Double-Blind, Randomised, Dysport and Placebo-Controlled, Dose-Escalation and Dose-Finding Study to Evaluate the Safety and Efficacy of IPN10200 in the Treatment of Adult Upper Limb Spasticity. - LANTIMA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 244
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 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.
- •Type of Participant and Disease Characteristics
- •2. Has spastic hemiparesis following stroke or TBI
- •3. Is at least 6 months post-stroke or TBI
- •4. 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
- •5. Has a MAS score =2 in the PTMG to be injected
- •6. Is eligible to receive a total recommended dose 1000 U Dysport in the upper limb when applicable.
- •7. Has angle of spasticity =5° in the PTMG to be injected.
- •8. Does not have any fixed contractures as defined by:
- •Complete fingers extension with XV1 =160°
- •Complete wrist extension with XV1 =90°
- •Complete elbow extension with XV1 =160°
- •9. 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.
- •10. 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
- •11. 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) as defined in Section 10.4 Appendix 4:
- •Contraceptive and Barrier Guidance.
- •Is a WOCBP and using an acceptable contraceptive method as described in Section 10.4 Appendix 4: Contraceptive and Barrier
- •Guidance 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), see Section 8.2.5.
- •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
- •o Additional requirements for pregnancy testing during and after study
- •intervention are located in Section 8.2.5.
- •o The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Informed Consent
- •12. Capable of giving signed informed consent as described in Appendix 10.1 which includes
- •compliance with the requirements and restrictions listed in the informed consent form
- •(ICF) and in this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects fo
排除标准
- •Medical Conditions
- •1. Any medical condition (including but not limited to severe dysphagia or airway disease severe impairment of ability to walk (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 (AEs) related to BoNT treatment.
- •Known disease of the neuromuscular junction (e.g. Lambert-Eaton myasthenic syndrome, myasthenia gravis or amyotrophic lateral sclerosis etc.).
- •3. Has a history of hypersensitivity to the investigational medicinal products (or other
- •BoNTs) or any excipient used in their formulation.
- •4. 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. Prior/concomitant Therapy
- •5. Likely treatment with any serotype of BoNT for any condition during the study.
- •6. Undergone previous surgery to treat spasticity in the affected upper limb.
- •7. 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).
- •8. Has received previous treatment with phenol and or alcohol in the targeted upper limb any time before the study.
- •9. 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.
- •10. 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.
- •11. 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. For patients taking vitamin K antagonists, the INR values should be controlled (between 2 and 3).
- •12. 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.
- •Prior/concurrent Clinical Study Experience
- •13. 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.
- •Diagnostic Assessments
- •14. 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.
- •15. 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. Highly effective methods of contraception are defined as methods of birth control which result in a low failure rate (i.e. less than 1% per year) when
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