NCT01119677

A Study of Avonex to Determine the Effects of Dose Titration on the Incidence of Flu Like Symptoms in Healthy Volunteers

A Randomized, Three-Arm, Dose-Blinded, Parallel-Group Study to Determine the Effect of Avonex® Dose Titration on the Severity and Incidence of Interferon Beta-1a-Related Flu Like Symptoms in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to determine whether titration of Avonex reduces the severity of flu-like symptoms (FLS). Secondary objectives of this study are to determine whether titration of Avonex reduces the incidence of FLS and to evaluate the overall safety and tolerability of Avonex intramuscular (IM) injections.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Avonex	Group 1 subjects will receive weekly Avonex 30 mcg (full dose) IM injections from Week 1 to Week 8. Group 2 subjects will titrate in quarter dose increments every week up to a full dose of Avonex over a 3 week period from Week 1 to Week 3 and then continue on full dose from Week 4 to Week 8. Group 3 subjects will titrate in quarter dose increments every 2 weeks up to a full dose of Avonex over a 6 week period from Week 1 to Week 6 and continue on full dose from Week 7 to Week 8

Timeline

• Start date: 2010-05-05
• Primary completion: 2010-10-23
• Completion: 2010-10-23
• First posted: 2010-05-07
• Last updated: 2017-11-17

Locations

1 site across 1 country: United States