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A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis

NCT00914290 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2019-11-06

No results posted yet for this study

Summary

To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation of symptoms of spasticity associated with multiple sclerosis (MS).

Conditions

Interventions

DRUG

IPX056

IPX056 ER capsule containing 10 mg baclofen

DRUG

Baclofen IR

Encapsulated baclofen tablet 5 mg per capsule

DRUG

Placebo IPX056

Placebo capsule for IPX056

DRUG

Placebo IR

Placebo encapsulated baclofen placebo tablet

Sponsors & Collaborators

  • Impax Laboratories, LLC

    lead INDUSTRY

Principal Investigators

  • Impax Study Director · Impax Laboratories, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-01-31
Completion
2010-02-28
FDA Drug
Yes

Countries

  • United States

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 NCT00914290 on ClinicalTrials.gov