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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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer 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.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Placebo
Orale tabletter
Legemiddel: Nal er
Orale tabletter
Andre navn:
  • Nalbufin
Eksperimentell: 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.
Legemiddel: Placebo
Orale tabletter
Legemiddel: Nal er
Orale tabletter
Andre navn:
  • Nalbufin
Eksperimentell: 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.
Legemiddel: Placebo
Orale tabletter
Legemiddel: Nal er
Orale tabletter
Andre navn:
  • 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.
Legemiddel: Placebo
Orale tabletter

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Relativ endring fra baseline i 24-timers hostefrekvens i uke 6
Tidsramme: Baseline, uke 6
Baseline, uke 6

Sekundære resultatmål

Resultatmål
Tidsramme
Endring fra baseline i Leicester Cough Questionnaire (LCQ) Total score i uke 6
Tidsramme: Baseline, uke 6
Baseline, uke 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Trevi Therapeutics

Etterforskere

  • Studieleder: Chief Development Officer, Trevi Therapeutics

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. juni 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. september 2027

Datoer for studieregistrering

Først innsendt

22. juni 2026

Først innsendt som oppfylte QC-kriteriene

22. juni 2026

Først lagt ut (Faktiske)

26. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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