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

Study Overview
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Brief Summary
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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.

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

Conditions
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Back Pain

Intervention / Treatment
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* Drug: Arbaclofen placarbil, 20 mg
* Drug: Placebo
* Drug: Arbaclofen placarbil, 30 mg
* Drug: Arbaclofen placarbil, 40 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain severity score using the VAS |  | 4 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute back pain in the lumbar region