Clinical Trial: Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Preliminary Efficacy of Dexpramipexole in Patients With Chronic Sinusitis With Nasal Polyps and Eosinophilia (CSNP-E)
Brief Summary: Phase 2, open-label, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 6 months in subjects with chronic sinusitis with nasal polyps and eosinophilia.
Detailed Summary:
This open-labelled study will evaluate the safety and preliminary efficacy of dexpramipexole for reducing the number of eosinophils in the peripheral blood and in improving nasal polyp score when administered to 20 subjects with chronic sinusitis with nasal polyps and eosinophilia.
Subjects will received dexpramipexole for up to 6 months and will have safety tests performed monthly and will have efficacy evaluations performed at month 1, month 3, and month 6 after beginning study drug.
Sponsor: Knopp Biosciences
Current Primary Outcome: Peripheral eosinophil count and nasal polyp score [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety [ Time Frame: 6 months ]
- frequency and severity of adverse events over time after dexpramipexole is administered to subjects with CSNP-E.
- changes in clinical safety laboratory parameters over time after dexpramipexole is administered to subjects with CSNP-E.
- changes in ECG parameters over time after dexpramipexole is administered to subjects with CSNP-E.
- changes in vital signs over time after dexpramipexole is administered to subjects with CSNP-E.
Original Secondary Outcome: Same as current
Information By: Knopp Biosciences
Dates:
Date Received: August 12, 2014
Date Started: August 2014
Date Completion:
Last Updated: February 28, 2017
Last Verified: February 2017