EUCTR2022-002965-13-FR进行中（未招募）1 期
A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •Informed Consent
- •1. Participant is willing and able to understand and fully comply with study procedures and requirements (including digital tools and applications), in the opinion of the investigator.
- •2. Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and/or electronic consent [eConsent]) and any required privacy authorization before the initiation of any study procedures.
- •Type of Participant and Disease Characteristics
- •3. Participant with a diagnosis of narcolepsy who has completed a controlled study with TAK-861 (including participants diagnosed with NT1 or NT2) and for whom the investigator has no clinical objection to their enrollment. Additionally, a rare exception may be granted by the sponsor or designee for a participant who was unable to complete a previous TAK-861 controlled study conducted in participants with narcolepsy.
- •Contraception
- •4. The participant agrees to follow the birth control requirements
- •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 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Medical Conditions
- •1. Participant has a moderate or severe ongoing (TEAE) related to the study drug from the parent study or discontinued because of TEAEs in the parent study.
- •Prior/Concomitant Therapy
- •2. Participant used disallowed medication during the parent study and is unable to refrain from or anticipates using excluded medications.
- •Diagnostic Assessments
- •3. Participant has a (BP) >160 mm Hg (systolic) or >100 mm Hg (diastolic) at the final collection point in any prior controlled study without a dosing gap. The participant may have a history of hypertension and be on antihypertensive medication treatment as long as the BP values are below these criteria. BP measurements should be obtained after the participant has been semirecumbent (lying down with the head of the bed at 30 degrease) for a minimum of 5 minutes. BP will be repeated 3 times, with a minimum of 2 minutes between assessments. The median BP (of 3 assessments) obtained will be used for assessing participant eligibility.
- •4. Participant has a resting HR outside of the range of 40 to 100 beats per minute, confirmed on repeat testing within a maximum of 30 minutes at assessment at screening.
- •5. Participant has an ECG with a (QTcF) interval>450 ms (men) or >470 ms (women) at screening.
- •6. Participant has (ALT) and (AST) >1.5 times the (ULN) at multiple visits in the parent study and the findings are of clinical significance, per investigator or sponsor opinion, or ALT/AST >1.5 times ULN during the screening period for participants with a dosing gap.
- •7. Participant’s renal creatinine clearance is =50 mL/min.
- •8. Participant has a positive urine screen for drugs of abuse (findings confirmed) and/or positive alcohol test during any visit in their prior TAK-861 study, or during the screening period for participants with a dosing gap. Products containing cannabidiol are allowed throughout the study, at the discretion of the investigator.
- •9. Participant has a positive pregnancy test at screening or is a lactating/breastfeeding woman.
- •10. Participant has a risk of suicide according to endorsement of item 4 or 5 on the C-SSRS Since Last Visit (C-SSRS) on any visit in the prior study, or has positive answers on item 4 or 5 on the Screening/Baseline C-SSRS Lifetime (based on the past year) during the screening assessment for participants with a dosing gap.
- •Other Exclusion Criteria
- •11. Participant consumes excessive amounts of caffeine, defined as greater than 600 mg of caffeine of coffee, tea, cola, energy drinks, or other caffeinated beverages per day (1 cup of coffee is approximately 120 mg).
- •12. Participant is unwilling to refrain from drivingand/or operating dangerous or hazardous machinery during times of heightened sleepiness or fatigue as well as during times of medication weaning/changes, or is unwilling to adhere to local regulations and any PI guidance restricting driving.
- •Participants with a Dosing GapUp to 3 Months
- •Additional exclusion criteria for participants who have completed their parent study and who are not able to directly roll over into the current study (ie, for whom there is a dosing gap), are as follows:
- •13. Participant has participated in another investigational drug study, in which they received the investigational drug other than TAK-861, within 60 days (or 6 months if participant may have received an investigational biologic product). The interval window from the parent study will be derived from the date of the last study procedure in the parent st
研究者
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