EUCTR2014-005303-24-DE进行中（未招募）1 期
A Multicenter, Long-term, Open-label Study to Evaluate the Safety of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines and Lateral Canthal Lines
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Medytox Inc
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Completion of lead-in Phase 3 study: Study MT10109L-001 for GL participants, Study MT10109L-002 for LCL participants, Studies MT10109L-005 or-006 for GL and LCL participants.
- •- Stable medical condition, in the opinion of the investigator
- •- Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period
- •- Female participants of childbearing potential must have a negative urine pregnancy test before each study intervention. A female is considered NOT to be of childbearing potential if she is premenarchal, postmenopausal (at least 12 consecutive months without menstruation), or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral oophorectomy).
- •- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- •- Written informed consent from the participant has been obtained prior to any study-related procedures.
- •- Written documentation has been obtained in accordance with the relevant country and
- •local privacy requirements, where applicable (eg, Written Authorization for Use and
- •Release of Health and Research Study Information [US sites] and written Data Protection
- •consent [EU sites])
- •- Ability to follow study instructions, including completing study assessment tools without
- •any assistance or alteration to the assessment tools and likely to complete all required
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 760
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Known immunization or hypersensitivity to any botulinum toxin serotype
- •- Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with
- •neuromuscular function
- •- Any brow or eyelid ptosis, as determined by the investigator
- •- Infection or skin disorder at the injection sites
- •- Any uncontrolled systemic disease
- •- Recent history of alcohol or drug abuse based on the investigator’s judgement
- •- Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention)
- •- Anticipated need for surgery or overnight hospitalization during the study
- •- Known allergy or sensitivity to any of the components of the study interventions, or any
- •materials used in the study procedures
- •- Current enrollment in an investigational drug or device study or participation in such a
- •study within 30 days of entry into this study, except the prior qualifying lead-in Phase 3
- •- Females who are pregnant, nursing, or planning a pregnancy during the study. Females of
- •childbearing potential, not using a reliable means of contraception.
- •- Participants who plan for an extended absence away from the immediate area of the
- •study site that would preclude them from returning for all protocol-specified study visits
- •- Participants who, in the investigator’s opinion, are unable or unwilling to maintain their
- •standardized skin care regimen throughout the study period
- •- The participant has a condition or is in a situation which, in the investigator’s opinion,
- •may put the participant at significant risk, may confound the study results, or may
- •interfere significantly with the participant’s participation in the study.
研究者
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