Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525877-38-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with Idiopathic Pulmonary Fibrosis (IPF).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAL ER 54 mg | Experimental | Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving NAL ER 54 milligrams (mg) twice daily (BID) for 52 weeks. |
|
| Placebo | Placebo Comparator | Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving a matching placebo BID for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAL ER | Drug | Oral tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change from Baseline in 24-hour Cough Frequency at Week 26 | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 26 | Baseline, Week 26 | |
| Relative Change from Baseline in 24-hour Cough Frequency at Week 6 | Baseline, Week 6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paula Buckley | Contact | (203) 304-2499 | Paula.Buckley@trevitherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Chief Development Officer | Trevi Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Specialists of The Palm Beaches | Recruiting | Loxahatchee Groves | Florida | 33470 | United States | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Oral tablets |
|
| Percentage of Participants Achieving ≥50% Reduction from Baseline in 24-hour Cough Frequency at Week 26 | Baseline, Week 26 |
| Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 26 | Baseline, Week 26 |
| Percentage of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS at Week 26 | Baseline, Week 26 |
| Absolute Change from Baseline in the E:RS IPF Breathlessness Domain at Week 26 | Baseline, Week 26 |
| Relative Change from Baseline in 24-hour Cough Frequency | Baseline up to Week 54 |
| Percentage of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-Hour Cough Frequency | Baseline up to Week 54 |
| Absolute Change from Baseline in the E-RS:IPF Cough Domain | Baseline up to Week 54 |
| Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms) | Baseline up to Week 54 |
| Absolute Change from Baseline in the CS-NRS | Baseline up to Week 54 |
| Percentage of Participants Achieving a ≥3-Point Improvement from Baseline in CS-NRS | Baseline up to Week 54 |
| Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores | Baseline up to Week 54 |
| Percentage of Participants Achieving a 1.3-Point Increase (Improvement) from Baseline in LCQ Total Score | Baseline up to Week 54 |
| Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social) | Baseline up to Week 54 |
| Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 26 | Baseline, Week 26 |
| Relative Change from Baseline in Awake Cough Frequency | Baseline up to Week 54 |
| Relative Change from Baseline in Sleep Cough Frequency | Baseline up to Week 54 |
| Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score | Baseline up to Week 54 |
| Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score | Baseline up to Week 54 |
| Percentage of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough | Baseline up to Week 54 |
| Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to Week 57 |
| Clinical Research and Associates, Inc. |
| Recruiting |
| Miami |
| Florida |
| 33126 |
| United States |
| Clinical Research of Gastonia (CRG) | Recruiting | Gastonia | North Carolina | 28054 | United States |
| El Paso Pulmonary Association, PA | Recruiting | El Paso | Texas | 79902 | United States |
| Elevate Clinical Research | Recruiting | Houston | Texas | 77058 | United States |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
Not provided
Not provided