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NCT03319732 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS
A Phase 3 study of Multiple Sclerosis and Spasticity, Muscle, sponsored by RVL Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 323
- Enrollment target
- 1
- Study location
NCT03319732: Completed Phase 3 study of Multiple Sclerosis and Spasticity, Muscle, sponsored by RVL Pharmaceuticals.
NCT03319732 is a Phase 3 study of Multiple Sclerosis and Spasticity, Muscle that has completed, run by RVL Pharmaceuticals. The registered enrollment target is 323 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03319732, a Phase 3 study of Multiple Sclerosis and Spasticity, Muscle, has completed, sponsored by RVL Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 323 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Safety and tolerability will be assessed by the monitoring of adverse events volunteered, observed, and elicited by general questions in a non-suggestive manner. Changes in vital signs, clinical laboratory test results, 12-lead ECGs, the urinary symptom profile (USP) questionnaire, and the C-SSRS results will also be assessed.
Conditions Studied
Interventions
- DRUG Arbaclofen
Study Locations (1)
California
- Neuro Pain Medical Center - Fresno
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2018-04-03 |
| Est. Completion | 2020-06-11 |
| Phase | Phase 3 |
What the finished NCT03319732 record still lists
NCT03319732 is an interventional study that assigns participants to a tested intervention. The registered 323 participants enrollment target is mid-sized for trials with a published cap, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (45% lower).
The record links to 2 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Arbaclofen is the first listed.
NCT03319732 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03319732 about?
NCT03319732 is a clinical study titled "A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS". 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 ext...
What is the current status of trial NCT03319732?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 323 participants. The study started on 2018-04-03. Estimated completion is 2020-06-11.
What conditions does trial NCT03319732 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Spasticity, Muscle.
What interventions are being tested in trial NCT03319732?
The interventions under investigation include: Arbaclofen (DRUG).
Who is sponsoring clinical trial NCT03319732?
This trial is sponsored by RVL Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03319732 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03319732's enrollment target sits among peer trials
323 54th of 315 higher than 262 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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