TAPLUCAINIUM CHLORIDE for Refractory chronic cough | Unexplained chronic cough

Inclusion criteria

• {"criterion_text":"- Refractory or unexplained chronic cough for ≥ 12 months"}
• {"criterion_text":"- Women of childbearing potential agree to follow the protocol-specified contraceptive guidance during the study"}
• {"criterion_text":"- Males who are not vasectomized must agree to use the contraceptive methods defined in the protocol"}
• {"criterion_text":"- Able to provide Informed Consent"}

Exclusion criteria

• {"criterion_text":"- Previous exposure to taplucainium (formerly NTX-1175) or known allergy or hypersensitivity to taplucainium, its excipients/metabolites, or related compounds."}
• {"criterion_text":"- Current opiate/opioid use or medical history of opiate/opioid use disorder."}
• {"criterion_text":"- History of concurrent malignancy or recurrence of malignancy in the last 2 years"}
• {"criterion_text":"- Body Mass Index (BMI) of ≥40 kg/m2"}
• {"criterion_text":"- Positive results for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus"}
• {"criterion_text":"- Unable to refrain from the use of medications and treatments that can impact cough during the study."}
• {"criterion_text":"- Have clinically significant history or evidence of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s)"}
• {"criterion_text":"- Participants who are currently participating in another drug or device clinical study"}
• {"criterion_text":"- Participants who have participated in an Acute or Chronic Cough investigational study within 60 days before the start of the Screening."}
• {"criterion_text":"- Current diagnosis of chronic obstructive pulmonary disease (COPD), bronchiectasis, unexplained pulmonary fibrosis, hemoptysis, bronchial asthma (not including resolved childhood asthma), or other pulmonary disease"}
• {"criterion_text":"- Respiratory tract infection within 4 weeks of Screening."}
• {"criterion_text":"- Any female who is pregnant or lactating or wishing to become pregnant."}
• {"criterion_text":"- Donation of > 1 Unit (450 milliliter [mL] or more) of blood within 60 days prior to Screening."}
• {"criterion_text":"- Alcohol or drug use disorder within the past 2 years"}
• {"criterion_text":"- Current smoker/vaper or individuals who have given up smoking within the past 6 months of Screening, and/or those with >20 pack-year smoking history."}

Primary endpoints

• {"endpoint_text":"- Change in 24-hour Coughs per hour from Baseline to Day 28 (based on VitaloJAK® Cough Counts)","definition_or_measurement_approach":"Based on VitaloJAK® Cough Counts (change from Baseline to Day 28 in 24-hour coughs per hour)."}

Secondary endpoints

• {"endpoint_text":"- Change in Awake coughs per hour from Baseline to Day 28 (based on VitaloJAK® Cough Counts)","definition_or_measurement_approach":"Based on VitaloJAK® Cough Counts (awake coughs per hour change from Baseline to Day 28)."}
• {"endpoint_text":"- Change in the Cough Severity Visual Analog Scale (CS-VAS) from Baseline to Day 28","definition_or_measurement_approach":"Change from Baseline to Day 28 measured using the Cough Severity Visual Analog Scale (CS-VAS)."}
• {"endpoint_text":"- Change in the Urge to Cough Visual Analog Scale (UC-VAS) from Baseline to Day 28","definition_or_measurement_approach":"Change from Baseline to Day 28 measured using the Urge to Cough Visual Analog Scale (UC-VAS)."}
• {"endpoint_text":"- Change in the Leicester Cough Questionnaire (LCQ) from Baseline to Day 28","definition_or_measurement_approach":"Change from Baseline to Day 28 measured by the Leicester Cough Questionnaire (LCQ)."}
• {"endpoint_text":"- Patient Global Impressions of Improvement (PGI-I) score at Day 28","definition_or_measurement_approach":"PGI-I score assessed at Day 28 (patient-reported global impression of improvement)."}
• {"endpoint_text":"- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)","definition_or_measurement_approach":"Safety assessed by reporting incidence and severity of AEs and SAEs."}

Methods

• Call center outreach and scripted inbound/outbound appointment call scripts (call centre scripts and FAQs present) targeting potential patient participants and facilitating appointment scheduling (documents available in multiple languages / country versions).
• Digital Patient Brochure and Participant Brochure (digital channels) targeting patients with refractory or unexplained chronic cough (country-specific versions: EN, PL, FR, NL, DE).
• Pre-screening website content / Pre-screener to allow online pre-screening of potential participants (country-specific content present).
• Doctor-to-patient letters and Physician referral brochures/letters to engage referring physicians to identify eligible patients (country-specific versions).
• Offline materials: Participant flyers, posters, and pre-enrollment cards distributed at sites or clinics (country-specific versions).
• Animation video/storyboard used for outreach and digital advertising to raise awareness among potential participants (country-specific versions).
• ePR Participant Journey Emails (participant journey emails) to engage pre-enrolled participants and support retention.
• Warm transfer process / New site call scripts to transfer callers from outreach to site staff for scheduling.
• DTP (Direct-to-patient) outreach and advertising (materials and country-specific DTP outreach documents).
• Hyfe app / continuous cough monitoring onboarding materials and push notifications shown in patient-facing documents (digital remote monitoring support).

Poland

Earliest CTIS Part Ii Submission Date

18-11-2024

Latest Decision Or Authorization Date

01-12-2025

Processing Time Days

378

Number Of Sites

9

Number Of Participants

24

Belgium

Earliest CTIS Part Ii Submission Date

14-11-2024

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

445

Number Of Sites

4

Number Of Participants

18

Germany

Earliest CTIS Part Ii Submission Date

07-11-2024

Latest Decision Or Authorization Date

07-05-2026

Processing Time Days

546

Number Of Sites

9

Number Of Participants

24

Primary sponsor

Full Name

Nocion Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Q Squared Solutions Limited

Responsibilities

code 4

Name

4g Clinical LLC

Responsibilities

code 3

Name

Q Squared Solutions LLC

Responsibilities

code 4

Third parties

• {"country":"France","full_name":"Cerba","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC Platform","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code 4","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cisys Inc.","duties_or_roles":"Patient Eligibility/Adjudication","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Cardiology","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Vitalograph (Ireland) Limited","duties_or_roles":"24 Hour Cough Monitoring","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Hyfe Inc.","duties_or_roles":"Continuous Cough Monitoring","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"Spirometry","organisation_type":"Pharmaceutical company"}