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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00817986
Enrollment
161
Registered
2009-01-07
Start date
2008-12-31
Completion date
2009-07-31
Last updated
2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain

Keywords

Acute back pain in the lumbar region

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.

Interventions

DRUGArbaclofen placarbil, 20 mg

tablets

DRUGPlacebo

tablets

DRUGArbaclofen placarbil, 30 mg

tablets

DRUGArbaclofen placarbil, 40 mg

tablets

Sponsors

XenoPort, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of treatment-emergent adverse events14 DaysSafety was assessed based on the incidence, intensity and relationship of treatment emergent AEs

Secondary

MeasureTime frame
Change in pain severity score using the VAS4 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026