Effect of Oseltamivir on Cognitive Function in Subjects With Influenza (FOCUS)

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Trial Management Group Inc.
ClinicalTrials.gov Identifier:
NCT01249833
First received: November 26, 2010
Last updated: April 18, 2013
Last verified: September 2012
  Purpose

This study has been designed to determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention / working memory / processing speed / mood as compared to subjects receiving standard of care alone. The cognitive tests employed are objective measures developed and administered online by HeadMinder Inc.


Condition Intervention Phase
Influenza
Drug: Oseltamivir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised, Open-label, Multi-Centre, Phase IV Study Assessing the Effect of Oseltamivir Treatment on Cognitive Function in Subjects With Confirmed Influenza Virus Infection

Resource links provided by NLM:


Further study details as provided by Trial Management Group Inc.:

Primary Outcome Measures:
  • Attention [ Time Frame: 4 days ] [ Designated as safety issue: No ]

    Attention assessed using simple reaction time. Simple reaction time calculated as the mean of the following 2 sub-tests:

    • Reaction Time Subtest
    • Cued Reaction Time Subtest


Secondary Outcome Measures:
  • Working memory and processing speed [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Working memory measured with the Dot Memory Test. Processing speed measured with Animal Number Decoding


Other Outcome Measures:
  • Mood (alertness, calmness and contentment) [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Mood assessed using the Bond-Lader scales; factored for alertness, calmness and contentment.

  • Influenza symptoms [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Sum of the severity ratings (0 - 3) for 7 symptoms assessed daily.


Enrollment: 122
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oseltamivir
Added to standard of care for influenza
Drug: Oseltamivir
Oseltamivir 75mg BID for 5 days
Other Name: Tamiflu
No Intervention: Standard of care alone
Standard of care for influenza

Detailed Description:

Primary Objective:

To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention as compared to subjects receiving standard of care alone.

Secondary Objectives:

To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in working memory and processing speed as compared to subjects receiving standard of care alone.

Supportive Objectives:

  1. To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in self-rated alertness as compared to subjects receiving standard of care alone.
  2. To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in self-rated calmness and contentment as compared to subjects receiving standard of care alone.
  3. To determine if there is a correlation between the rate of improvement in symptom scores and the rate of change in attention and working memory.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult men and women, 18 - 65 years of age (inclusive)
  2. Indicative symptoms/signs of uncomplicated acute illness due to influenza infection (A or B strains) that started within a maximum of 2 days prior to Visit 1 as per the Tamiflu® Canadian product label. Signs and symptoms may include the following:

    • Fever
    • Respiratory symptoms (cough, coryza, sore throat, rhinitis)
    • Constitutional symptoms (headache, malaise, myalgia, sweats and/or chills, fatigue)
  3. Positive rapid antigen test for influenza (A or B strains) at Visit 1
  4. Negative urine pregnancy test at Visit 1 for women of childbearing potential; women of childbearing potential who are sexually active must agree to use a suitable form of contraception during the study. Acceptable birth control measures include: hysterectomy, birth control pills, tubal ligation, intrauterine device, hormonal injections and implants, double barrier methods (such as a condom with a diaphragm or a condom with spermicide), and abstinence. Oral contraceptives must be in stable use for 2 or more cycles prior to screening. Intrauterine device (IUD) must be in use at least 30 days prior to study drug administration. Barrier methods must be in use at least 14 days prior to study drug administration.
  5. Subjects must:

    • have daily access to a computer at home with: internet access (preferably high-speed for optimal performance but dial-up can be used as well); Microsoft operating system; Internet Explorer browser capability and an e-mail account. A Macintosh (Mac) computer cannot be used.
    • be capable of and willing to complete the required online assessments in English according to the protocol schedule
    • be willing to abstain from the use of an antiviral medication if they are randomised to the standard of care treatment arm
    • have provided written informed consent prior to the initiation of any study procedures

Exclusion Criteria:

  1. More than 2 days since the onset of influenza symptoms
  2. Subjects who, in the Investigator's judgment, require treatment with an antiviral medication as per the Canadian "Clinical Recommendations for Patients Presenting with Respiratory Symptoms During the 2009 - 2010 Influenza Season" (see Appendix D)
  3. Clinical suspicion of infection with a respiratory virus other than influenza
  4. Any medical condition that is sufficiently severe or unstable such that the subject is considered to be at imminent risk of requiring hospitalisation
  5. History of conditions that may potentially affect cognitive function during the study, such as underlying neurologic conditions, depression or depressive disorders (unless the condition and treatment have been stable for 3 months), seasonal affective disorder (SAD), or any other cognitive impairment or dementia
  6. Intermittent use of sedative-hypnotics; subjects who have been taking a fixed dose of a sedative-hypnotic every day for a period of at least 30 days may be included provided that they continue the same regimen throughout the study.
  7. Intermittent or chronic use of psychiatric medications (with the exception of antidepressants that have been stable for 3 months) or anti-epileptic drugs
  8. Nursing home residents
  9. Known allergy to oseltamivir phosphate or any of the inactive ingredients of Tamiflu®
  10. Women who are pregnant, or planning to become pregnant, or who are lactating
  11. Current alcohol or drug abuse or substance dependence
  12. Participation in another clinical trial with an investigational drug within the last 30 days
  13. Patients vaccinated for influenza within 6 months of study enrollment
  14. In the Investigator's judgment, the subject will not be able to adhere to the protocol requirements or is not suitable for study participation for any reason
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249833

Locations
Canada, British Columbia
Dr. Collette
Vancouver, British Columbia, Canada
Dr. Lai
Vancouver, British Columbia, Canada
Canada, Newfoundland and Labrador
Topsail Road Medical Clinic
St. John's, Newfoundland and Labrador, Canada
Canada, Ontario
Moran Medical Centre
Collingwood, Ontario, Canada
Dr. Kanani
Etobicoke, Ontario, Canada
Milestone Research
London, Ontario, Canada
Dr. Herman
London, Ontario, Canada
SKDS Research Inc
Newmarket, Ontario, Canada
Family First Medical Centre
Orleans, Ontario, Canada
Steeple Hill Medical Centre
Pickering, Ontario, Canada, L1V 2A6
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, Canada
DCTM Clinical Trials Group Ltd.
Strathroy, Ontario, Canada
Dr. Gupta
Toronto, Ontario, Canada
Devonshire Clinical Research Inc.
Woodstock, Ontario, Canada
Canada, Saskatchewan
Regina Medical Centre
Regina, Saskatchewan, Canada, S4P 3X1
Sponsors and Collaborators
Trial Management Group Inc.
Hoffmann-La Roche
Investigators
Principal Investigator: Dr. O'Mahony, M.D. London Road Diagnostic Clinic and Medical Centre
  More Information

No publications provided

Responsible Party: Trial Management Group Inc.
ClinicalTrials.gov Identifier: NCT01249833     History of Changes
Other Study ID Numbers: CAI-001-10
Study First Received: November 26, 2010
Last Updated: April 18, 2013
Health Authority: Canada: Health Canada

Keywords provided by Trial Management Group Inc.:
Influenza
Cognition
Attention
Simple Reaction Time
Alertness
Calmness
Contentment
Mood

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014