Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness

January 25, 2023 updated by: Emergo Therapeutics, Inc.

A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Norketotifen (NKT) in the Treatment of Acute Uncomplicated Influenza-like Illness (ILI)

This is a Phase 2b, multi-center, double-blind, randomized, placebo-controlled, parallel-group study of NKT versus placebo in otherwise healthy adults presenting with acute uncomplicated ILI due to influenza or other respiratory viruses in a community setting.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
315

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Precision Trials AZ
    • California
      • Los Angeles, California, United States, 90017
        • Downtown LA Research Center
    • Florida
      • DeBary, Florida, United States, 32713
        • Omega Research DeBary
      • Kissimmee, Florida, United States, 34744
        • The Chappel Group Research
      • Miami, Florida, United States, 33135
        • South Florida Research Center
      • Miami, Florida, United States, 33165
        • Premier Research Associate
      • Miami, Florida, United States, 33173
        • Research Institute of South Florida
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Horizon Research Group of Opelousas
    • Maryland
      • Towson, Maryland, United States, 21204
        • Continental Clinical Solutions
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Clinical Research of South Nevada
    • North Carolina
      • Louisburg, North Carolina, United States, 27549
        • Relief Integrated Health Care
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Clinical Research Solutions
    • Pennsylvania
      • Scottdale, Pennsylvania, United States, 15683
        • Frontier Clinical Research
      • Smithfield, Pennsylvania, United States, 15478
        • Frontier Clinical Research
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Clinovacare Medical Research Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Clinical Research Solutions
    • Texas
      • Dallas, Texas, United States, 75251
        • Cedar Health Research
      • Houston, Texas, United States, 77027
        • Advanced Medical Group
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Frontier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Able to understand the study and comply with all study procedures, and willing to provide written informed consent prior to the pre-dose examinations

  2. Symptoms of ILI including all of the following:

    • Fever ≥38º Celsius (oral)
    • At least one of the following general systemic symptoms associated with ILI are present with a severity of moderate or greater: headache, feverishness or chills, muscle or joint pain, fatigue
    • At least one of the following respiratory symptoms associated with ILI are present with a severity of moderate or greater: cough, sore throat, nasal congestion
  3. Total symptom severity score (sum of the scores of all 7 individual symptoms) of ≥11 in the predose examinations
  4. The time interval between the onset of symptoms and the predose examinations is ≤48 hours.
  5. Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol

Exclusion Criteria:

  1. Known or suspected infection with Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV2) or Coronavirus Disease 2019 (COVID-19) illness
  2. Female subjects who are pregnant, 2 weeks post-partum, or breastfeeding
  3. Severe ILI requiring inpatient treatment

  4. Any of the following risk factors (according to the CDC's list of People at High Risk for Developing Serious Flu-Related Complications):

    • Extreme obesity (body mass index ≥40 kg/m^2)
    • Residents of nursing homes or other long-term care facilities
    • American Indians and Alaska natives
    • Asthma
    • Chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)
    • Neurological and neurodevelopmental conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle such as cerebral palsy, epilepsy [seizure disorders], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury)
    • Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease)
    • Blood disorders (such as sickle cell disease)
    • Endocrine disorders (such as diabetes mellitus)
    • Kidney disorders
    • Liver disorders
    • Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
    • Compromised immune system due to disease or medication (such as subjects with human immunodeficiency virus or cancer, or those on chronic steroids)
  5. Presence of any severe or uncontrolled medical or psychiatric illness
  6. History of or current autoimmune disease
  7. History of recurrent lower respiratory tract infection
  8. Any concurrent infection requiring systemic antimicrobial and/or antiviral therapy
  9. Any clinically significant electrocardiogram (ECG) test
  10. Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the predose examinations
  11. Received an investigational monoclonal antibody for a viral disease in the last year prior to the predose examinations
  12. Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the predose examinations
  13. Exposure to an investigational drug within 30 days prior to the predose examinations
  14. History of allergic reaction to ketotifen
  15. Any prior exposure to norketotifen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Norketotifen
Norketotifen oral capsules, twice daily for 7 days
Drug: Norketotifen
Oral capsule
Placebo Comparator: Placebo
Placebo oral capsules, twice daily for 7 days
Drug: Placebo
Oral capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to alleviation of symptoms
Time Frame: 14 days
Time to alleviation of the symptoms of ILI (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to resolution of fever (body temperature equal to or less than 37ºC)
Time Frame: 14 days
14 days
Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
Time Frame: 14 days
14 days
Time to resumption of normal activity
Time Frame: 14 days
14 days
Use of rescue medication (acetaminophen)
Time Frame: 14 days
14 days
Proportion of subjects whose symptoms have been alleviated at each time point through Day 14
Time Frame: 14 days
14 days
Change from baseline in composite symptom score at each time point through Day 14
Time Frame: 14 days
14 days
Body temperature at each time point through Day 14
Time Frame: 14 days
14 days
Time to alleviation of symptoms by confirmed viral pathogen (influenza vs non influenza)
Time Frame: 14 days
14 days
Time to resolution of fever by confirmed viral pathogen (influenza vs non influenza)
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emergo Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 9, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NKT-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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