Recruiting
Phase 2

Nalbuphine ER

Sponsor:

Trevi Therapeutics

Code:

NCT07671924

Conditions

Refractory Chronic Cough

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NAL ER

Placebo

Study Details

Brief summary:

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.

Conditions

Refractory Chronic Cough

Study ID

NCT07671924

Start date

Jun 22, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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.

placebo comparator: 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.

Interventions

NAL ER

Oral tablets

Placebo

Oral tablets

Primary outcome measure

  • Relative Change From Baseline in 24-hour Cough Frequency at Week 6 [ Time Frame: Baseline, Week 6 ]

Central Contacts and Locations

Central contacts

Paula Buckley

(203) 304-2499Paula.Buckley@trevitherapeutics.com

Locations

Dynamic Drug Advancement Ltd

Recruiting

Ajax, Canada, L1S 2J5

BLC Clinical Research

Recruiting

Burlington, Canada, L7N3V2

Recherche GCP Research

Recruiting

Montreal, Canada, H1Y3H5

Medical Arts Health Research Group - North Vancouver

Recruiting

North Van Couver, Canada, V7P2T4

Diex Recherche - Quebec

Recruiting

Québec, Canada, G1V4T3

Clinique Specialisee En Allergie De La Capitale

Recruiting

Québec, Canada, G1V4W2

Clinque DE Pneumologie ET Du Sommeil DE Lanaudiere

Recruiting

Saint-Charles-Borromée, Canada, J6E 2B4

Centre D'Investigation Clinique Mauricie Inc (CIC Mauricie)

Recruiting

Trois-Rivières, Canada, G8T7A1

Diex Recherche-Victoriaville

Recruiting

Victoriaville, Canada, G6P3Z8

Fadia El Boreky Medicine Prof. Corp.

Recruiting

Waterloo, Canada, N2J1C4

More Information

Sponsor

Trevi Therapeutics

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Trevi Therapeutics on 2026-08-10.