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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03424733
Date of registration: 31/01/2018
Prospective Registration: No
Primary sponsor: Holy Name Medical Center, Inc.
Public title: Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side Effects
Scientific title: A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a
Date of first enrolment: September 25, 2017
Target sample size: 50
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03424733
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Mary Ann Picone, MD
Address: 
Telephone: 201-837-0727
Email: M-picone@mail.holyname.org
Affiliation: 
Name:     Mary Ann Picone, MD
Address: 
Telephone: 201-837-0727
Email: m-picone@mail.holyname.org
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- diagnosed any form of MS (relapsing remitting, primary progressive, secondary
progressive), any EDSS (expanded stability status scale) score

Exclusion Criteria:

- prior allergic reaction to interferon products, congestive heart failure, elevated
liver enzymes



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
Intervention(s)
Drug: Prednisone
Drug: Tylenol Pill
Drug: Plegridy
Primary Outcome(s)
Flu-like symptoms [Time Frame: 12 to 16 weeks]
Secondary Outcome(s)
Injection site reactions [Time Frame: 12 to 16 weeks]
Secondary ID(s)
US-PEG-16-10990
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Biogen
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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