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A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS

NCT03290131 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 536

Last updated 2022-07-15

Study results available
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Summary

Multiple Sclerosis (MS) is an acquired inflammatory demyelinating disease of the central nervous system (CNS) that is regarded as the foremost cause of non-traumatic neurologic disability in adults in North America. 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.

Conditions

Interventions

DRUG

Arbaclofen

Arbaclofen Extended Release Tablet

DRUG

Placebo

Placebo comparator

Sponsors & Collaborators

  • Osmotica Pharmaceutical US LLC

    collaborator INDUSTRY

  • RVL Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David Jacobs, MD · Vice President

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-28
Primary Completion
2018-12-03
Completion
2019-01-02
FDA Drug
Yes

Countries

  • Belarus
  • Bosnia and Herzegovina
  • Bulgaria
  • Croatia
  • Moldova
  • Poland
  • Serbia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03290131 on ClinicalTrials.gov