IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis

Summary

The purpose of this study is to determine the effects, both good and bad, of IPX056 on subjects and their spasticity. This study will also determine the relationship between the amount of IPX056 in blood and the effects on spasticity. Lastly, this study will determine how long IPX056 affects spasticity.

Conditions

• Multiple Sclerosis

Interventions

DRUG

IPX056 20 mg

IPX056 Extended Release capsule containing 20 mg baclofen

DRUG

IPX056 40 mg

IPX056 Extended Release capsule containing 40 mg baclofen

DRUG

Encapsulated Baclofen 20 mg

Baclofen 20mg tablet was encapsulated for blinding.

DRUG

Placebo Baclofen Tablet

Placebo capsule encapsulated placebo Baclofen tablet

DRUG

IPX056 10 mg

IPX056 Extended Release capsule containing 10 mg baclofen

DRUG

IPX056 30 mg

IPX056 Extended Release capsule containing 30 mg baclofen

DRUG

IPX056 35 mg

IPX056 Extended Release capsule containing 35 mg baclofen

DRUG

Placebo IPX056 20 mg

Placebo capsule for IPX056 20 mg

DRUG

Placebo IPX056 40 mg

Placebo capsule for IPX056 40 mg

Sponsors & Collaborators

• Impax Laboratories, LLC

  lead INDUSTRY

Principal Investigators

• Impax Study Director · Impax Laboratories, LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2008-05-31

Completion

2008-05-31

Countries

• United States
• Canada
• Estonia
• Latvia
• Ukraine

Study Locations