NCT00488839

IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis

A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the PK and PD of IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Impax Laboratories, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to demonstrate that IPX056 reduces spasticity, measured by Ashworth score, in subjects with multiple sclerosis (MS). This study will also (1) assess the correlation between pharmacokinetic (PK) and pharmacodynamic (PD) endpoints (Ashworth score), and (2) quantify the duration of pharmacodynamic effects for IPX056 as well as marketed baclofen tablet in subjects with Multiple Sclerosis (MS) after a single dose. Additionally, the efficacy parameters, including Multiple Sclerosis Impact Scale (MSIS)-29, spasm frequency and nighttime awakening score, spasticity control, morning stiffness, and Global Assessment of Efficacy and Tolerability, will be assessed during open-label extension period. The safety of IPX056 will be monitored throughout the study. This study consists of 2 parts: Part I (Screening Visit \& Visit 1) of the study is a single-dose, double-blind, randomized, placebo- and active comparator-controlled, parallel group design containing a single 12 hour PK/PD evaluation period. Part II is an optional, approximately 9-week open-label extension study and will start during Visit 1, immediately after Visit 1 PK/PD procedures are completed.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-06-20
• Last updated: 2019-11-06

Locations

31 sites across 5 countries: United States, Canada, Estonia, Latvia, Ukraine