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

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of XP19986 in Subjects With Acute Back Spasms

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.

Study Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Drug: Placebo; Drug: Arbaclofen placarbil, 20 mg; Drug: Arbaclofen placarbil, 30 mg; Drug: Arbaclofen placarbil, 40 mg

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
  • California
    • Anaheim, California, United States, 92801
    • Anaheim, California, United States, 92084
    • San Diego, California, United States, 92128
    • Vista, California, United States, 92083
  • Florida
    • Fort Lauderdale, Florida, United States, 33306
    • Miami, Florida, United States, 33143
  • Georgia
    • Atlanta, Georgia, United States, 30308
  • Kansas
    • Overland Park, Kansas, United States, 66211
  • Kentucky
    • Erlanger, Kentucky, United States, 41018
  • Michigan
    • Traverse City, Michigan, United States, 49684
  • New Jersey
    • Brick, New Jersey, United States, 07732
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
    • Winston-Salem, North Carolina, United States, 27103
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73122
  • South Carolina
    • Anderson, South Carolina, United States, 29621
  • Texas
    • Dallas, Texas, United States, 75234
    • Houston, Texas, United States, 77074
    • San Antonio, Texas, United States, 78215
  • Utah
    • Salt Lake City, Utah, United States, 84106

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arbaclofen placarbil 20 mg; Arbaclofen placarbil 20 mg, BID, for 14 days including the taper period.	Drug: Arbaclofen placarbil, 20 mg; tablets; Other Names: XP19986 SR3
Placebo Comparator: Placebo for Arbaclofen placarbil; Placebo for 14 days	Drug: Placebo; tablets; Other Names: Sugar Pill
Experimental: Arbaclofen placarbil 30 mg; Arbaclofen placarbil 30 mg, BID, for 14 days including the taper period.	Drug: Arbaclofen placarbil, 30 mg; tablets; Other Names: XP19986 SR3
Experimental: Arbaclofen placarbil 40 mg; Arbaclofen placarbil 40 mg, BID, for 14 days including the taper period.	Drug: Arbaclofen placarbil, 40 mg; tablets; Other Names: XP19986 SR3 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events	Safety was assessed based on the incidence, intensity and relationship of treatment emergent AEs	14 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in pain severity score using the VAS	4 Days

Collaborators and Investigators

• Sponsor: XenoPort, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: January 6, 2009
• First Submitted That Met QC Criteria: January 6, 2009
• First Posted (Estimate): January 7, 2009

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Acute back pain in the lumbar region
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; GABA Agents; Neuromuscular Agents; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Baclofen; Arbaclofen placarbil
• Other Study ID Numbers: XP-B-083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO