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Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough

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ClinicalTrials.gov Identifier: NCT03282591
Recruitment Status : Active, not recruiting
First Posted : September 14, 2017
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Menlo Therapeutics Inc.

Brief Summary:
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of refractory chronic cough

Condition or disease Intervention/treatment Phase
Refractory Chronic Cough Drug: 5 mg Serlopitant Tablets Drug: Matching Placebo Tablets Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: 5 mg Serlopitant Tablets
Serlopitant Tablets
Drug: 5 mg Serlopitant Tablets
Serlopitant Tablets
Other Name: VPD-737

Placebo Comparator: Matching Placebo Tablets
Placebo Tablets
Drug: Matching Placebo Tablets
Placebo Tablets




Primary Outcome Measures :
  1. Change from baseline in 24-hour objective cough frequency [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in awake objective cough frequency [ Time Frame: 12 weeks ]
  2. Proportion of subjects with ≥ 30% reduction in 24-hour objective cough frequency per hour [ Time Frame: 12 weeks ]
  3. Proportion of subjects with ≥30% reduction in awake objective cough frequency per hour [ Time Frame: 12 weeks ]
  4. Change from Baseline in Cough Severity Visual Analog Scale (VAS) [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and males between 18 and 80 years of age
  • Have a diagnosis of treatment refractory chronic cough or unexplained cough for at least one year
  • Chest radiograph or computed tomography (CT) Thorax within the last 5 years not demonstrating any abnormality considered to be significantly contributing to the chronic cough
  • At Screening have a score of ≥ 40mm on the Cough Severity VAS
  • At Baseline (Day 0) have a score of ≥ 40mm on the Cough Severity VAS
  • All female subjects who are of childbearing potential must practice highly effective contraception (i.e., pregnancy prevention method with a failure rate of < 1% per year) from the time of the initial screening visit until 4 weeks after last dose of study drug. Please refer to the protocol for acceptable methods of contraception

Exclusion Criteria:

  • Prior treatment with serlopitant or other NK1-R antagonist
  • Presence of any medical condition or disability that could interfere with study
  • History of hypersensitivity to serlopitant or any of its components
  • Currently pregnant or male partner of pregnant female
  • Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding
  • Current smoker or individuals who have given up smoking within the past 12 months
  • FEV1/FVC < 60%
  • Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2 at Screening
  • History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit (Day 0)
  • History of cystic fibrosis
  • History of opioid use within 1 week of the Baseline Visit (Day 0)
  • Requiring concomitant therapy with prohibited medications
  • Treatment with biologic therapies within 8 weeks or 5 half-lives prior to the Baseline Visit (Day 0), whichever is longer
  • Treatment with strong CYP3A4 inhibitors within 4 weeks prior to the Baseline Visit (Day 0)
  • Treatment with any investigational therapy within 4 weeks (investigational biologic therapies within 8 weeks) prior to the Baseline Visit (Day 0)
  • Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x the upper limit of normal (ULN) during screening
  • Positive test for any drug of abuse
  • History of malignancy within 5 years prior to the Baseline Visit (Day 0), with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin
  • Any known psychiatric diagnosis meeting DSM-5 criteria which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to randomization. Examples of such DSM-5 diagnoses include but are not limited to major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder.
  • Known active hepatitis infection
  • Known history of human immunodeficiency virus (HIV) infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282591


  Show 39 Study Locations
Sponsors and Collaborators
Menlo Therapeutics Inc.
Investigators
Principal Investigator: Jacky Smith University of Manchester, United Kingdom

Responsible Party: Menlo Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03282591     History of Changes
Other Study ID Numbers: MTI-110
2017-003250-16 ( EudraCT Number )
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Serlopitant
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs