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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: 29 July 2022
Main ID:  NCT03290131
Date of registration: 19/09/2017
Prospective Registration: Yes
Primary sponsor: RVL Pharmaceuticals, Inc.
Public title: A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS OS440-3004
Scientific title: A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis
Date of first enrolment: January 28, 2018
Target sample size: 536
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03290131
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).  
Phase:  Phase 3
Countries of recruitment
Belarus Bosnia and Herzegovina Bulgaria Croatia Moldova, Republic of Poland Serbia United States
Contacts
Name:     David Jacobs, MD
Address: 
Telephone:
Email:
Affiliation:  Vice President
Key inclusion & exclusion criteria
Health Condition(s) or Problem(s) studied
Intervention(s)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 15/07/2022
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT03290131
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