MedTrace Logo

One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity

NCT01844232 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-04-25

No results posted yet for this study

Summary

Clinical protocol OS440-3003 is a multicenter, open-label, non-randomized, uncontrolled, dose escalation study to evaluate the safety and tolerability of Arbaclofen Extended Release Tablets over 1 year in Multiple Sclerosis (MS) subjects with spasticity. All subjects in this study will receive arbaclofen in the extended release tablet formulation.

Conditions

Interventions

DRUG

arbaclofen

Arbaclofen ER tablets, 20 mg, 30 mg and 40 mg

Sponsors & Collaborators

  • Osmotica Pharmaceutical US LLC

    collaborator INDUSTRY

  • RVL Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Praveen Tyle, Ph.D. · Osmotica Pharmaceutical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • United States
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT01844232 on ClinicalTrials.gov