A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms

Phase 2

Completed

• Conditions: Back Pain
• Interventions: Drug: Arbaclofen placarbil, 20 mg; Drug: Arbaclofen placarbil, 30 mg; Drug: Placebo; Drug: Arbaclofen placarbil, 40 mg

• Registration Number: NCT00817986
• Lead Sponsor: XenoPort, Inc.

Brief Summary

The purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil sustained release tablets taken every 12 hours compared to placebo in subjects with acute back spasms in the lumbar region.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-06
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Disposition First Submitted: 2010-09-08
• Disposition First Submitted QC: 2010-09-10
• Disposition First Posted: 2010-09-14
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

1. Acute moderate to severe muscle spasms in the lumbar region, as indicated by a minimum Visual Analog Scale pain severity score of 4.0 cm, beginning either:

   • within four days prior to screening for subjects who do not require a 24-hour washout

   Or

   • within three days for subjects who require a 24-hour washout

2. Willing to discontinue all analgesics (e.g. NSAIDS, COX-2 inhibitors, acetaminophen), aspirin >81 mg/day, short-acting muscle relaxants (i.e. carisoprodol, Soma®), and herbal remedies for pain at least 24 hours prior to first dose and to refrain from use during the study (cardio-protective doses of aspirin ≤ 81 mg /day are allowed).

Exclusion Criteria

1. Clinically significant abnormal neurological history or examination at screening (excluding back spasm), including lumbar radicular symptoms, spinal stenosis, foot drop, herniated nucleus pulposus, or other structural defects

2. Subjects with back spasm related to major trauma to the region

3. Subjects with muscle spasms due to a work-related injury or subjects involved in any injury-related litigation

4. Subjects using any of the following medications at screening:

   • Opioids, both short- and long-acting including but not limited to: morphine, fentanyl patch, oxycodone, tramadol)
   • benzodiazepines, such as valium and lorazepam
   • cyclobenzaprine containing drugs (e.g., Flexeril, Amrix)
   • carisoprodol (e.g., Soma®) within 24 hours of screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arbaclofen placarbil 20 mg	Arbaclofen placarbil, 20 mg	Arbaclofen placarbil 20 mg, BID, for 14 days including the taper period.
Arbaclofen placarbil 30 mg	Arbaclofen placarbil, 30 mg	Arbaclofen placarbil 30 mg, BID, for 14 days including the taper period.
Placebo for Arbaclofen placarbil	Placebo	Placebo for 14 days
Arbaclofen placarbil 40 mg	Arbaclofen placarbil, 40 mg	Arbaclofen placarbil 40 mg, BID, for 14 days including the taper period.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	14 Days	Safety was assessed based on the incidence, intensity and relationship of treatment emergent AEs

Secondary Outcome Measures

Name	Time	Method
Change in pain severity score using the VAS	4 Days