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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:  NCT03319732
Date of registration: 13/10/2017
Prospective Registration: Yes
Primary sponsor: RVL Pharmaceuticals, Inc.
Public title: A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS OS440-3005
Scientific title: An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005)
Date of first enrolment: April 3, 2018
Target sample size: 323
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03319732
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
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/NCT03319732
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