At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 323 enrolled
Drug / intervention
Arbaclofendrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005)
In Brief
A Phase 3 clinical trial evaluating Arbaclofen for Multiple Sclerosis and Spasticity, Muscle. Completed, enrolled 323 participants across 1 site.
Detailed Summary
Spasticity is a common complication in MS and occurs in up to 84% of patients. The main sign of spasticity is resistance to passive limb movement characterized by increased resistance to stretching, clonus, and exaggerated deep reflexes. Osmotica Pharmaceutical is currently developing arbaclofen extended-release tablets (AERT) for the treatment of spasticity in patients with MS.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Spasticity, Muscle
CountriesUnited States
CollaboratorsOsmotica Pharmaceutical US LLC
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartApr 2018
Primary CompletionJan 2020
Study CompletionJun 2020
TodayJul 2026
First PostedOct 24, 2017
Enrollment StartApr 3, 2018
Primary CompletionJan 27, 2020
Study CompletionJun 11, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.7 years ago
Interventions
Arbaclofendrug
Arbaclofen is the active R enantiomer of baclofen.