Effect of Oseltamivir on Cognitive Function in Subjects With Influenza

Influenza Clinical Trial

— FOCUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249833
• Other study ID #: CAI-001-10
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2010
• Last updated: April 18, 2013
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: September 2012
• Source: Trial Management Group Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Oseltamivir
Oseltamivir 75mg BID for 5 days

Locations

Country	Name	City	State
Canada	Moran Medical Centre	Collingwood	Ontario
Canada	Dr. Kanani	Etobicoke	Ontario
Canada	Dr. Herman	London	Ontario
Canada	Milestone Research	London	Ontario
Canada	SKDS Research Inc	Newmarket	Ontario
Canada	Family First Medical Centre	Orleans	Ontario
Canada	Steeple Hill Medical Centre	Pickering	Ontario
Canada	Regina Medical Centre	Regina	Saskatchewan
Canada	London Road Diagnostic Clinic and Medical Centre	Sarnia	Ontario
Canada	Topsail Road Medical Clinic	St. John's	Newfoundland and Labrador
Canada	DCTM Clinical Trials Group Ltd.	Strathroy	Ontario
Canada	Dr. Gupta	Toronto	Ontario
Canada	Dr. Collette	Vancouver	British Columbia
Canada	Dr. Lai	Vancouver	British Columbia
Canada	Devonshire Clinical Research Inc.	Woodstock	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Trial Management Group Inc.	Hoffmann-La Roche

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mood (alertness, calmness and contentment)	Mood assessed using the Bond-Lader scales; factored for alertness, calmness and contentment.	4 days	No
Other	Influenza symptoms	Sum of the severity ratings (0 - 3) for 7 symptoms assessed daily.	14 days	No
Primary	Attention	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	4 days	No
Secondary	Working memory and processing speed	Working memory measured with the Dot Memory Test. Processing speed measured with Animal Number Decoding	4 days	No