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The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC) (LAKE)

5. august 2026 opdateret af: Trevi Therapeutics

A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Participants With Refractory Chronic Cough

The purpose of this study is to evaluate the efficacy and safety of Nalbuphine ER Extended-release tablets for the treatment of participants with RCC.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Fase 2

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Connie Crum

Studiesteder

  • Canada
      • Ajax, Canada, L1S 2J5
        • Rekruttering
        • Dynamic Drug Advancement Ltd
      • Burlington, Canada, L7N3V2
        • Rekruttering
        • BLC Clinical Research
      • Montreal, Canada, H1Y3H5
        • Rekruttering
        • Recherche GCP Research
      • North Van Couver, Canada, V7P2T4
        • Rekruttering
        • Medical Arts Health Research Group - North Vancouver
      • Québec, Canada, G1V4T3
        • Rekruttering
        • Diex Recherche - Quebec
      • Québec, Canada, G1V4W2
        • Rekruttering
        • Clinique Specialisee En Allergie De La Capitale
      • Saint-Charles-Borromée, Canada, J6E 2B4
        • Rekruttering
        • Clinque DE Pneumologie ET Du Sommeil DE Lanaudiere
      • Trois-Rivières, Canada, G8T7A1
        • Rekruttering
        • Centre D'Investigation Clinique Mauricie Inc (CIC Mauricie)
      • Victoriaville, Canada, G6P3Z8
        • Rekruttering
        • Diex Recherche-Victoriaville
      • Waterloo, Canada, N2J1C4
        • Rekruttering
        • Fadia El Boreky Medicine Prof. Corp.

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

Inclusion Criteria:

  • Meets society guideline-based criteria for a diagnosis of RCC defined as:

    • Insufficient improvement in cough after treatment for any identified cough-associated conditions.
    • Unexplained cough for which an underlying condition has not been determined despite adequate investigation with diagnostic tests and trials of therapy.
  • Persistent and chronic cough for at least one year prior to Screening.
  • Chest computed tomography (CT) or chest radiograph of the thorax performed within the last 24 months and after the onset of chronic cough OR the procedure completed by the Investigator during the Screening period, that does not show any abnormality considered to be significantly contributing to the RCC in the opinion of the Principal Investigator.
  • 24-hour objective cough frequency ≥10 coughs/hour based on VitaloJAK® cough monitor recording performed during the Screening and Placebo Run-in Periods as well as a minimum recording duration of 20 hours suitable for analysis during the placebo Run-in assessment.
  • Forced expiratory volume in 1 second (FEV1) /forced vital capacity (FVC) ratio ≥ 60% as determined by spirometry adhering to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines.

Exclusion Criteria:

  • Clinical diagnosis of sleep apnea and/or use of continuous positive airway pressure (CPAP).
  • Upper or lower respiratory tract infection or change in pulmonary status in the 4 weeks prior to the Screening visit or during the Screening or PBO Run-in periods.
  • History of bronchiectasis, chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF), or other significant respiratory disorder that might affect cough.

  • History of uncontrolled asthma defined as one of the following:

    • ≥1 clinically significant exacerbation in the last 6 months, OR
    • ≥2 clinically significant exacerbations in the past 12 months (a clinically significant asthma exacerbation is defined as requiring the use of systemic corticosteroids).
  • Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or nicotine vaper.
  • Individuals who have stopped smoking or vaping within the past 6 months, or those with >20 pack-year smoking history.
  • Current active tuberculosis or nontuberculous mycobacterial infection, a history of latent untreated tuberculosis, or a history of incompletely treated tuberculosis.
  • Speech therapy/physiotherapy for RCC starting within 4 weeks of Baseline or during the study. Speech therapy/physiotherapy is acceptable if the participant has started the therapy more than 4 weeks prior to the Baseline visit AND plans to continue the therapy through the Titration and Fixed-dose Treatment Period.
  • Known intolerance [gastrointestinal, central nervous system (CNS) symptoms], hypersensitivity, or drug allergy considered to be related to an opioid drug or known hypersensitivity to nalbuphine or to NAL ER excipients.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: NAL ER 54 mg BID
Participants will receive NAL ER during the titration period, with dose titration starting at 27 milligrams (mg) once daily (QD) and increasing up to 54 mg twice daily (BID) from Day 1 to Day 14. Participants will receive NAL ER 54 mg BID during the fixed-dose treatment period from Day 15 to Day 42.
Medicin: Placebo
Orale tabletter
Medicin: Nal er
Orale tabletter
Andre navne:
  • Nalbufin
Eksperimentel: NAL ER 27 mg BID
Participants will receive NAL ER during the titration period, starting at 27 mg QD to 27 mg BID from Day 1 to Day 14. Participants will receive NAL ER 27 mg BID during the fixed-dose treatment period from Day 15 to Day 42.
Medicin: Placebo
Orale tabletter
Medicin: Nal er
Orale tabletter
Andre navne:
  • Nalbufin
Eksperimentel: NAL ER 27 mg QD
Participants will receive NAL ER 27 mg QD during the titration period from Day 1 to Day 14. Participants will continue to receive NAL ER 27 mg QD during the fixed-dose treatment period from Day 15 to Day 42.
Medicin: Placebo
Orale tabletter
Medicin: Nal er
Orale tabletter
Andre navne:
  • Nalbufin
Placebo komparator: Placebo
Participants will receive matching placebo during the titration period from Day 1 to Day 14 and the fixed-dose treatment period from Day 15 to Day 42.
Medicin: Placebo
Orale tabletter

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Relativ ændring fra baseline i 24-timers hostefrekvens i uge 6
Tidsramme: Baseline, uge ​​6
Baseline, uge ​​6

Sekundære resultatmål

Resultatmål
Tidsramme
Ændring fra baseline i Leicester hoste spørgeskema (LCQ) samlet score i uge 6
Tidsramme: Baseline, uge ​​6
Baseline, uge ​​6
Relative Change From Baseline in 24-hour Cough Frequency
Tidsramme: Baseline up to Week 6
Baseline up to Week 6
Percentage of Participants Achieving ≥30%, ≥50% and ≥75% Reduction in 24-hour Cough Frequency
Tidsramme: Baseline up to Week 6
Baseline up to Week 6
Change From Baseline in Patient Reported Cough Frequency (PR-CF)
Tidsramme: Baseline up to Week 6
Baseline up to Week 6
Change From Baseline in Cough Severity Visual Analog Scale (CS-VAS)
Tidsramme: Baseline up to Week 6
Baseline up to Week 6
Percentage of Participants Achieving a 30 Millimeter (mm) Improvement in CS-VAS Total Score
Tidsramme: Baseline up to Week 6
Baseline up to Week 6
Change From Baseline in Cough Severity Numerical Rating Scale (CS-NRS)
Tidsramme: Baseline up to Week 6
Baseline up to Week 6
Change From Baseline in McMaster Cough Severity Questionnaire (MCSQ) Total Score
Tidsramme: Baseline up to Week 6
Baseline up to Week 6
Change From Baseline in MCSQ Domains (Intensity and Frequency)
Tidsramme: Baseline up to Week 6
Baseline up to Week 6
Change From Baseline in Each LCQ Domain Score (Physical, Psychological, Social) at Week 6
Tidsramme: Baseline, Week 6
Baseline, Week 6
Percentage of Participants Achieving a 1.3- Point Increase From Baseline in LCQ Total Score at Week 6
Tidsramme: Baseline, Week 6
Baseline, Week 6
Relative Change From Baseline in Awake Cough Frequency
Tidsramme: Baseline up to Week 6
Baseline up to Week 6
Relative Change From Baseline in Sleep Cough Frequency
Tidsramme: Baseline up to Week 6
Baseline up to Week 6
Change From Baseline in Patient Global Impression of Severity (PGI-S) Cough Score
Tidsramme: Baseline up to Week 6
Baseline up to Week 6
Mean Patient Global Impression of Change for Cough (PGI-C) Cough Score
Tidsramme: Up to Week 6
Up to Week 6
Change From Baseline in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) Score at Week 6
Tidsramme: Baseline, Week 6
Baseline, Week 6
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Up to Day 63
Up to Day 63

Samarbejdspartnere og efterforskere

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

Sponsor

Trevi Therapeutics

Efterforskere

  • Studieleder: Chief Development Officer, Trevi Therapeutics

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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 (Faktiske)

22. juni 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NAL04-202
  • 2026-526087-20-00 (Ctis)

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

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner