Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia (CS201)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02217332|
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : December 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Sinusitis With Nasal Polyps and Eosinophilia||Drug: dexpramipexole||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Preliminary Efficacy of Dexpramipexole in Patients With Chronic Sinusitis With Nasal Polyps and Eosinophilia (CSNP-E)|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||December 14, 2016|
|Actual Study Completion Date :||January 20, 2017|
dexpramipexole 150 mg BID
Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
- Peripheral eosinophil count and nasal polyp score [ Time Frame: 6 months ]Efficacy of dexpramipexole in reducing the number of eosinophils in the peripheral blood and in improving nasal polyp score when administered to subjects with CSNP-E.
- 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.
- anosmia [ Time Frame: 6 months ]Effect of dexpramipexole on improving sinusitis symptoms, including reversing anosmia and improving nasal patency
- CT scan score [ Time Frame: 6 months ]Effect of dexpramipexole on improving CT scan evidence of sinonasal disease
- asthma symptom scores [ Time Frame: 6 months ]Effect of dexpramipexole on improving symptoms of asthma
- Quality of life scores [ Time Frame: 6 months ]Effect of dexpramipexole on quality-of-life measures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217332
|United States, Florida|
|ENT Associates of South Florida|
|Boca Raton, Florida, United States, 33487|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21205|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, North Carolina|
|Wake Research Associates|
|Raleigh, North Carolina, United States, 27612|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Pittsburgh School of Medicine|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22903|