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

1. juni 2026 opdateret af: Centessa Pharmaceuticals (UK) Limited

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

Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness [EDS]). People living with these conditions might find it hard to stay alert and pay attention when they are at school, working, driving, or performing other daily activities.

While all conditions result in feeling sleepy, there are some differences in other common symptoms:

  • NT1: People with NT1 often feel very tired during the day and experience cataplexy. Cataplexy is a sudden loss of muscle strength, which can cause someone to collapse or lose control of their muscles for a short time. This is often triggered by strong emotions, such as laughter or surprise. They may also have trouble sleeping well at night.
  • NT2: People with NT2 feel sleepy during the day, just like NT1, but they do not have cataplexy.

Orexin is a protein in the brain that helps coordinate a system that plays an important role in helping people to stay awake during the daytime. Cleminorexton is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable cleminorexton is in NT1 and NT2 and learn about what the drug does to the body. Another goal of the study is to see if cleminorexton can help people with NT1 and NT2 feel less sleepy and make other symptoms better.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The SAPPHIRE Clinical Trial

The Sponsor may in the future, through a protocol amendment, expand the protocol to include participants with idiopathic hypersomnia (IH) in Cohort C.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

222

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29201
        • Rekruttering
        • Columbia, South Carolina

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Key Inclusion Criteria:

  • 18-70 years of age
  • Body Mass Index (BMI) within the range ≥ 17.0 and ≤ 45 kg/m^2 (inclusive)
  • Meets the diagnostic criteria of Narcolepsy Type 1 (NT1) or Type 2 (NT2) according to International Classification of Sleep Disorders, 3rd edition, Text Revision edition (ICSD-3-TR) criteria
  • Is willing and able to discontinue all medications used for the treatment of narcolepsy
  • Is willing and able to adhere to additional protocol requirements

Key Exclusion Criteria:

  • Medical disorder other than NT1 or NT2, that is associated with excessive daytime sleepiness (EDS)
  • Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group A - Narcolepsy Type 1 (Dose 1)
Medicin: cleminorexton
Oral cleminorexton capsule
Eksperimentel: Group A - Narcolepsy Type 1 (Dose 2)
Medicin: cleminorexton
Oral cleminorexton capsule
Placebo komparator: Group A - Narcolepsy Type 1 (placebo)
Medicin: Placebo
matchende placebo kapsel
Eksperimentel: Group B - Narcolepsy Type 2 (Dose 1)
Medicin: cleminorexton
Oral cleminorexton capsule
Eksperimentel: Group B - Narcolepsy Type 2 (Dose 2)
Medicin: cleminorexton
Oral cleminorexton capsule
Placebo komparator: Group B - Narcolepsy Type 2 (placebo)
Medicin: Placebo
matchende placebo kapsel

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in mean sleep latency (average of the first 4 trials) on the Maintenance of Wakefulness Test (MWT)
Tidsramme: Baseline to week 12
Baseline to week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in Epworth Sleepiness Scale (ESS) total score
Tidsramme: Baseline to Week 12
Baseline to Week 12
Weekly Cataplexy Rate (WCR)
Tidsramme: Week 12
Measurement specific to Group A
Week 12
Change from baseline in Narcolepsy Severity Scale for Clinical Trials (NSS-CT)
Tidsramme: Baseline to Week 12
Measurement specific to Group A
Baseline to Week 12
Change from baseline in Narcolepsy Severity Scale-2 for Clinical Trials (NSS2-CT) total score
Tidsramme: Baseline to Week 12
Measurement specific to Group B
Baseline to Week 12
Incidence, Severity, and casual relationship of participants with Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Baseline to Week 12
Baseline to Week 12
Number of participants with abnormal changes from baseline in clinical laboratory tests
Tidsramme: Baseline to Week 12
Baseline to Week 12
Number of participants with abnormal changes from baseline in vital signs
Tidsramme: Baseline to Week 12
Baseline to Week 12
Number of participants with abnormal changes from baseline in 12-lead electrocardiograms (ECGs)
Tidsramme: Baseline to Week 12
Baseline to Week 12
Number of participants with at least 1 endorsement of Item 4 or 5 on Columbia-Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Baseline to Week 12
Baseline to Week 12
Cmax: Maximum observed plasma concentration
Tidsramme: Baseline to Week 12
Baseline to Week 12
Tmax: Time of Maximum Concentration for cleminorexton
Tidsramme: Baseline to Week 12
Baseline to Week 12
AUC: Area under the plasma concentration-time curve
Tidsramme: Baseline to Week 12
Baseline to Week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centessa Pharmaceuticals (UK) Limited

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. maj 2026

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

13. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ORX750-004

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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