Phase 2 Efficacy Trial of Z160 in Lumbosacral Radiculopathy

NCT01655849 | Completed Phase 2

• 1 other identifier: Z160-LSR-201
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 23

Brief Summary

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

Conditions

Lumbosacral Radiculopathy

Outcome Measures

Primary Outcomes (1)

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

  Baseline to week 6

Secondary Outcomes (14)

• 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

• Rescue medication use

  Weeks 1,2,3,4,5,6

Study Arms (2)

Z160

EXPERIMENTAL

375mg BID

Drug: z160

placebo

PLACEBO COMPARATOR

matching placebo control

Drug: Placebo

Interventions

z160 DRUG

Z160

Placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• \. At screening, the subject has an average daily pain score for neuropathic pain due to LSR of ≥ 3 and ≤ 8 on the PI-NRS.
• \. If female, the subject must be postmenopausal (defined as no menstruation for at least 12 months), surgically sterilized for ≥3 months before the screening visit, or agree to use 2 reliable methods of contraception (oral, implantable, transdermal, or injectable contraceptives in conjunction with an intrauterine device or a barrier method) during the 6-week treatment period, during the 6 week posttreatment follow-up period, and for an additional 8 weeks after the last study visit (Week 12, Visit 9) to avoid pregnancy if of childbearing potential (defined as biologically capable of becoming pregnant). If male, the subject must agree to use condoms during the 6-week treatment period with the study drug, during the 6-week posttreatment follow up period, and for an additional 8 weeks after the last study visit (Week 12, Visit 9).

You may not qualify if:

• The subject has:
• 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
• A history of or a current diagnosis of schizophrenia or bipolar disorder
• Had a stroke or TIA ≤ 6 months before the screening visit
• Has an episode of major depression or generalized anxiety disorder ≤ 6 months before the screening visit.
• The subject has a history of or currently has any of the following conditions that, in the investigator's opinion, may interfere with the study procedures or compromise the subject's safety:
• Cardiovascular disease
• Gastrointestinal disease

Sponsors & Collaborators

• Zalicus: lead

Study Sites (23)

Investigative Site

Huntsville, Alabama, 35801, United States

Location

Investigative Site

Peoria, Arizona, 85381, United States

Location

Investigative Site

Anaheim, California, 92804, United States

Location

Investigative Site

Fresno, California, 93726, United States

Location

Investigative Site

Orange, California, 92868, United States

Location

Investigative Site

Sacramento, California, 95821, United States

Location

Investigative Site

Clearwater, Florida, 33756, United States

Location

Investigative Site

Clearwater, Florida, 33765, United States

Location

Investigative Site

Orlando, Florida, 32806, United States

Location

Investigative Site

Pinellas Park, Florida, 33781, United States

Location

Investigative Site

Plantation, Florida, 33317, United States

Location

Investigative Site

Royal Palm Beach, Florida, 33411, United States

Location

Investigative Site

Atlanta, Georgia, 30342, United States

Location

Investigative Site

Overland Park, Kansas, 66210, United States

Location

Investigative Site

Shreveport, Louisiana, 71105, United States

Location

Investigative Site

Boston, Massachusetts, 02135, United States

Location

Investigative Site

Hazelwood, Missouri, 63042, United States

Location

Investigative Site

Las Vegas, Nevada, 89144, United States

Location

Investigative Site

Medford, Oregon, 97504, United States

Location

Investigative Site

Duncansville, Pennsylvania, 16635, United States

Location

Investigative Site

Dallas, Texas, 75230, United States

Location

Investigative Site

Sandy City, Utah, 84070, United States

Location

Investigative Site

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Interventions

Z160

Study Officials

• Margaret Lee, PhD

  Zalicus Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: August 2, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

US (23)