A Study to Investigate the Effects of Cleminorexton Compared with Placebo in the Treatment of Participants with Central Disorders of Hypersomnolence

A vizsgálat adatai

Ki végzi

Centessa Pharmaceuticals UK Limited

Azonosító

EU 2026-525961-37-00

A regiszteradat frissítve

2026. november 12.

Eredeti leírás

Evaluate the effect of cleminorexton versus placebo on EDSA teljes eredeti leírásKevesebb

A Randomized, Double-blind, 3-Arm Parallel Design Study to Investigate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Cleminorexton Compared with Placebo in Participants with Central Disorders of Hypersomnolence

Evaluate the effect of cleminorexton versus placebo on EDS

Bevonási feltételek: A physician documented diagnosis of NT1 according to International Classification of Sleep Disorders, 3rd edition, Text Revision edition (ICSD-3-TR) criteria within the past 10 years from informed consent; Positive test result for the human leukocyte antigen (HLA) genotype HLA DQB1*06:02 (either during Screening or based on a documented historical test result); A mean sleep latency on the MWT (average of the first 4 trials) at Baseline of < 21 minutes; After washout of medications used for the treatment of cataplexy, must complete self-reported cataplexy questions in the diary for at least 11 days of the 14-day period prior to the Baseline visit and have ≥ 4 partial or complete episodes of cataplexy/week, averaged over 14 consecutive days prior to the Baseline visit; A physician documented diagnosis of NT2 according to ICSD-3-TR criteria within the past 10 years from informed consent; Mean sleep latency on the MWT (average of the first 4 trials) at Baseline of < 21 minutes.

Kizáró feltételek: Use of any medications that could affect the evaluation of cataplexy (including antidepressants) within 7 days before the baseline sleep diary. Participants must have returned to baseline level of cataplexy by the time of the beginning of the cataplexy diary, in the opinion of the investigator. "; Use of any medications that could affect the evaluation of EDS (eg, medications that stimulate the central nervous system [CNS]); Any medical disorder other than NT1 or NT2, that is associated with excessive daytime sleepiness (EDS): evidence of untreated or inadequately treated moderate-to-severe sleep-disordered breathing and/or periodic limb-movement-arousal index > 15; Conditions related to the following: cardiac, malignancy, gastrointestinal, endocrine, neurologic, psychiatric, immunologic, other significant conditions or comorbidities that would make the participant unsuitable to be randomized and/or participate; Use of medications for EDS (including wake-promoting agents, stimulants, and sodium oxybate or mixed-salt oxybate). Certain washout periods apply (see Appendix 10.7 for full details); Positive serum pregnancy test at Screening or Baseline, or is a pregnant, lactating/ female participant; QT interval using the Fridericia formula (QTcF) >450 msec for males or > 470 msec for females or evidence of clinically significant electrocardiogram (ECG) abnormality (eg, 2nd or 3rd degree atrioventricular block [known history of Mobitz Type I may be considered with approval from the Sponsor or designee], left bundle branch block [LBBB]); A cerebrospinal fluid (CSF) orexin A (OXA) > 110 pg/mL (if available); Use of hypnotics (including melatonin); Abnormalities at Screening or Baseline in blood pressure (BP, systolic BP > 140 mm Hg or < 90 mm Hg; diastolic BP > 90 mm Hg or < 50 mm Hg) or pulse rate (> 100 bpm or < 40 bpm); Usual bedtime later than 1:00 AM (01:00).

EU CTIS 2026-525961-37-00