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Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis

NCT01359566 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2021-02-21

No results posted yet for this study

Summary

To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo for the treatment of spasticity in subjects with multiple sclerosis (MS).

Conditions

Interventions

DRUG

Arbaclofen placarbil 15 mg BID

arbaclofen placarbil 15 mg BID

DRUG

Placebo

Placebo for arbaclofen placarbil 15, 30 and 45 mg BID

DRUG

Arbaclofen placarbil 30 mg BID

arbaclofen placarbil 30 mg BID

DRUG

Arbaclofen placarbil 45 mg BID

arbaclofen placarbil 45 mg BID

Sponsors & Collaborators

  • XenoPort, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Indivior Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

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 NCT01359566 on ClinicalTrials.gov