A Study to Evaluate the Long-term Safety and Tolerability of TAK-861
- Conditions
- Therapeutic area: Diseases [C] - Nervous System Diseases [C10]arcolepsy with Cataplexy (Type 1) and Narcolepsy without Cataplexy (Type 2)MedDRA version: 20.0Level: PTClassification code 10028713Term: NarcolepsySystem Organ Class: 10029205 - Nervous system disorders
- Registration Number
- EUCTR2022-002965-13-FR
- Lead Sponsor
- Takeda Development Center Americas, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate the long-term safety and tolerability of TAK-861.;Secondary Objective: • To assess the effect of TAK-861 on excessive daytime sleepiness (EDS) as assessed by the mean sleep latency from the Maintenance of Wakefulness Test(MWT)<br>• To assess the effect of TAK-861 on EDS as measured by the Epworth Sleepiness Scale (ESS) total score.<br>• To assess the effect of TAK-861 on cataplexy as assessed by the weekly cataplexy rate (WCR) (participants with narcolepsy type 1 <br>[NT1] only).;Primary end point(s): • Occurrence of at least 1 treatment-emergent adverse event (TEAE).;Timepoint(s) of evaluation of this end point: Day 395, 425, 485, 515, 575, 605, 665, 695
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Change from baseline in the parent study in MWT mean sleep latency.<br>• Change from baseline in the parent study in ESS total score<br>• Change from baseline in the parent study in WCR using the patient-reported cataplexy diary (participants with NT1 only);Timepoint(s) of evaluation of this end point: - Day 182<br>- Day 14, 28, 56, 84, 182, 266, 364, 448, 546, 630. 728 <br>- Day 69 to 84; 167 to 182; 251 to 266; 350to 364; 531 to 546; 715 to 728; 728 to 735