Clinical trial NCT01249833: Effect of Oseltamivir on Cognitive Function in Subjects With Influenza
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Cognition
Attention
Simple Reaction Time
Alertness
Calmness
Contentment
Mood
Lead sponsor: Trial Management Group Inc.
Sponsor class: NETWORK
Collaborators: name: Hoffmann-La Roche
First posted: 2010-11-30
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Change in Attention Assessment
timeFrame: Change from baseline at Day 4
Secondary outcomes:
measure: Change in Working Memory Assessment
timeFrame: Change from baseline at Day 4
measure: Change in Processing Speed Assessment
timeFrame: Change from baseline at Day 4
Other outcomes:
measure: Change in Mood Assessment
timeFrame: Change from baseline at Day 4
Locations:
city: Vancouver
country: Canada
facility: Dr. Collette
state: British Columbia
city: Vancouver
country: Canada
facility: Dr. Lai
state: British Columbia
city: St. John's
country: Canada
facility: Topsail Road Medical Clinic
state: Newfoundland and Labrador
city: Collingwood
country: Canada
facility: Moran Medical Centre
state: Ontario
city: Etobicoke
country: Canada
facility: Dr. Kanani
state: Ontario
city: London
country: Canada
facility: Dr. Herman
state: Ontario
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: Newmarket
country: Canada
facility: SKDS Research Inc
state: Ontario
city: Orleans
country: Canada
facility: Family First Medical Centre
state: Ontario
city: Pickering
country: Canada
facility: Steeple Hill Medical Centre
state: Ontario
city: Sarnia
country: Canada
facility: Dr. Martyn Chilvers - London Road Diagnostic Clinic and Medical Centre
state: Ontario
city: Sarnia
country: Canada
facility: Dr. Michael O'Mahony - London Road Diagnostic Clinic and Medical Centre
state: Ontario
city: Strathroy
country: Canada
facility: DCTM Clinical Trials Group Ltd.
state: Ontario
city: Toronto
country: Canada
facility: Dr. Gupta
state: Ontario
city: Woodstock
country: Canada
facility: Devonshire Clinical Research Inc.
state: Ontario
city: Regina
country: Canada
facility: Regina Medical Centre
state: Saskatchewan
Study officials:
affiliation: London Road Diagnostic Clinic and Medical Centre
name: Dr. O'Mahony, M.D.
role: PRINCIPAL_INVESTIGATOR
References: