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
1 other identifier
interventional
161
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2008
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 6, 2009
CompletedFirst Posted
Study publicly available on registry
January 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFebruary 21, 2021
February 1, 2021
7 months
January 6, 2009
February 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of treatment-emergent adverse events
Safety was assessed based on the incidence, intensity and relationship of treatment emergent AEs
14 Days
Secondary Outcomes (1)
Change in pain severity score using the VAS
4 Days
Study Arms (4)
Arbaclofen placarbil 20 mg
EXPERIMENTALArbaclofen placarbil 20 mg, BID, for 14 days including the taper period.
Placebo for Arbaclofen placarbil
PLACEBO COMPARATORPlacebo for 14 days
Arbaclofen placarbil 30 mg
EXPERIMENTALArbaclofen placarbil 30 mg, BID, for 14 days including the taper period.
Arbaclofen placarbil 40 mg
EXPERIMENTALArbaclofen placarbil 40 mg, BID, for 14 days including the taper period.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- within three days for subjects who require a 24-hour washout
- 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).
You may not qualify if:
- 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
- Subjects with back spasm related to major trauma to the region
- Subjects with muscle spasms due to a work-related injury or subjects involved in any injury-related litigation
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XenoPort, Inc.lead
Study Sites (20)
Unknown Facility
Litchfield Park, Arizona, 85340, United States
Unknown Facility
Anaheim, California, 92084, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
San Diego, California, 92128, United States
Unknown Facility
Vista, California, 92083, United States
Unknown Facility
Fort Lauderdale, Florida, 33306, United States
Unknown Facility
Miami, Florida, 33143, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Overland Park, Kansas, 66211, United States
Unknown Facility
Erlanger, Kentucky, 41018, United States
Unknown Facility
Traverse City, Michigan, 49684, United States
Unknown Facility
Brick, New Jersey, 07732, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Oklahoma City, Oklahoma, 73122, United States
Unknown Facility
Anderson, South Carolina, 29621, United States
Unknown Facility
Dallas, Texas, 75234, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
San Antonio, Texas, 78215, United States
Unknown Facility
Salt Lake City, Utah, 84106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Indivior Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2009
First Posted
January 7, 2009
Study Start
December 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
February 21, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share