NCT00914290

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Impax Laboratories, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

IPX056 was compared with commercially available tablets as it was designed to provide a prolonged duration of absorption to reduce dose frequency and/or to provide prolonged duration of antispasticity effect.

Conditions

• Spasticity
• Multiple Sclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-01-01
• Completion: 2010-02-01
• First posted: 2009-06-04
• Last updated: 2019-11-06

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study