A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms
Back Pain
About this trial
This is an interventional treatment trial for Back Pain focused on measuring Acute back pain in the lumbar region
Eligibility Criteria
Inclusion Criteria:
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
- 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:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Experimental
Arbaclofen placarbil 20 mg
Placebo for Arbaclofen placarbil
Arbaclofen placarbil 30 mg
Arbaclofen placarbil 40 mg
Arbaclofen placarbil 20 mg, BID, for 14 days including the taper period.
Placebo for 14 days
Arbaclofen placarbil 30 mg, BID, for 14 days including the taper period.
Arbaclofen placarbil 40 mg, BID, for 14 days including the taper period.