A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy and Safety of Z160 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

Zalicus1 site in 1 country141 target enrollmentAugust 2012

ConditionsLumbosacral Radiculopathy

Interventionsz160 Placebo

Drugsz160 Placebo

Overview

Phase: Phase 2
Intervention: z160
Conditions: Lumbosacral Radiculopathy
Sponsor: Zalicus
Enrollment: 141
Locations: 1
Primary Endpoint: Change in weekly average of daily pain scores (PI-NRS)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will compare Z160 and placebo in patients with Lumbosacral Radiculopathy for safety and efficacy for a period of 6 weeks.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

November 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zalicus

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subject must have a diagnosis of pain due to LSR, with all of the following characteristics:
•The subject perceives pain in one or both lower limbs at sites that are consistent with the area innervated by the L4, L5, or S1 nerve roots, with or without other sensory symptoms in the affected areas (typically, the pain may be perceived in the buttock, thigh, calf, leg, foot, or toes).
•The history of the pain suggests that the cause of the LSR is due to injury of the lumbosacral nerve root(s) by degenerative disease of the vertebrae in the lumbosacral spine or associated soft tissues (including the intervertebral discs).
•The duration of pain since onset is ≥ 12 weeks.
•Based on clinical history, the intensity of pain has been stable during the 2-week period before screening.
•In the investigator's opinion, the subject's diagnosis of LSR is supported by all of the following at screening:
•Based on the StEP instrument:
•Neurological examination of lower limbs shows impaired muscle power, sensory function, or deep tendon reflexes in the territory of the affected nerve roots.
•Pain/sensory disturbance in dermatomal/myotomal distribution is precipitated or exacerbated by straight leg raising (the straight-leg-raising test should be performed as specified in StEP).
•The total StEP score is ≥ 4 (indicative of LSR as the cause of the pain)

Exclusion Criteria

•The subject has:
•Neuropathic pain due to causes other than that specified in the inclusion criteria (e.g., postherpetic neuralgia; painful diabetic neuropathy; mononeuritis multiplex; central poststroke pain; failed back surgery in relation to the presenting episode of radiculopathy; spinal abscess, infection, hematoma, or malignancy; phantom limb pain; peripheral neuropathy due to alcoholism, malignancy, human immunodeficiency virus \[HIV\], syphilis; drug abuse; vitamin B12 deficiency; hypothyroidism; liver disease; toxic exposure).
•Pain that is associated with a substantial somatic pain component (e.g., non-neuropathic/musculoskeletal pain in lower limbs or other parts of the body apart from the back) or more than one cause or potential cause for pain symptoms.
•Any painful concurrent rheumatic disease such as, but not limited to, fibromyalgia, rheumatoid arthritis, or significant osteoarthritis.
•Any question regarding the acceptability of the etiology of the neuropathic pain should be discussed with the Zalicus medical monitor.
•In the investigator's opinion, the subject is unable to reliably delineate or assess his or her own pain by anatomical location/distribution (e.g., the subject cannot reliably tell the difference between his or her back pain and lower limb pain and cannot rate the intensity of each separately).
•The subject has pain in the lower limbs solely upon walking and not at rest.
•The subject has undergone surgery for LSR within the last 6 months or has received treatment with epidural injections, nerve blocks, or acupuncture for LSR within 4 weeks before screening.
•The subject has:
•A history of seizure, excluding pediatric febrile seizures, or currently has seizures

Arms & Interventions

Z160

375mg BID

Intervention: z160

placebo

matching placebo control

Intervention: Placebo

Outcomes

Primary Outcomes

Change in weekly average of daily pain scores (PI-NRS)

Time Frame: Baseline to week 6

Secondary Outcomes

Rescue medication use(Weeks 1,2,3,4,5,6)
Profile of Mood States (POMS)(Baseline to weeks 1,2,4,6)
Daily Sleep Interference Scale(Baseline to weeks 1,2,3,4,5,6)
Short Form 36 (SF-36)(Baseline to week 6)
Safety and tolerability(Baseline, weeks 1,2,3,4,5,6,7,12)
Relationship of plasma concentrations(Baseline to weeks 1,2,3,4,5,6)
Time to a 30% reduction in average daily pain score(Baseline to weeks 1,2,3,4,5,6)
Time to a 50% reduction in average daily pain score(Baseline to weeks 1,2,3,4,5,6)
Subjects who have greater than or equal to a 30% reduction in average daily pain score(Baseline to weeks 1,2,3,4,5,6)
Subjects who have greater than or equal to a 50% reduction in average daily pain score(Baseline to weeks 1,2,3,4,5,6)
Change in weekly average of daily pain scores (PI-NRS)(Baseline to weeks 1,2,3,4,5, 6)
Galer Neuropathic Pain Scale (NPS)(Baseline to weeks 1,2,4,6)
Patient Global Impression of Change (PGIC)(Baseline to week 6)
Modified Roland-Morris Disability Scale (RMDQ)(Baseline to weeks 1,2,4,6)