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Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

NCT01743651 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2022-04-25

No results posted yet for this study

Summary

This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled, parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS patients with spasticity.

Eligible subjects will be removed from anti-spasticity medications for at least one week and then begin study drug treatment with daily doses increasing up to the target dose which will then be maintained for at least 12 weeks. A down-titration will then occur over two weeks.

Conditions

Interventions

DRUG

arbaclofen

40 mg/day as 20 mg arbaclofen ER administered orally 2 times per day

DRUG

baclofen

80 mg/day as 20 mg baclofen administered orally 4 times per day

DRUG

Placebo

arbaclofen image matched placebo tablets administered orally 2 times/day or baclofen image matched placebo capsules administered orally 4 times/day

Sponsors & Collaborators

  • Osmotica Pharmaceutical US LLC

    collaborator INDUSTRY

  • RVL Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Praveen Tyle, PhD · Osmotica Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States
  • Russia
  • Ukraine

Study Locations

More Related Trials

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 NCT01743651 on ClinicalTrials.gov