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Phase 2 Efficacy Trial of Z160 in Lumbosacral Radiculopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01655849
Recruitment Status : Completed
First Posted : August 2, 2012
Last Update Posted : December 12, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Lumbosacral Radiculopathy Drug: z160 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: Z160
375mg BID
Drug: z160
Placebo Comparator: placebo
matching placebo control
Drug: Placebo

Primary Outcome Measures :
  1. Change in weekly average of daily pain scores (PI-NRS) [ Time Frame: Baseline to week 6 ]

Secondary Outcome Measures :
  1. Change in weekly average of daily pain scores (PI-NRS) [ Time Frame: Baseline to weeks 1,2,3,4,5, 6 ]
  2. Galer Neuropathic Pain Scale (NPS) [ Time Frame: Baseline to weeks 1,2,4,6 ]
  3. Patient Global Impression of Change (PGIC) [ Time Frame: Baseline to week 6 ]
  4. Modified Roland-Morris Disability Scale (RMDQ) [ Time Frame: Baseline to weeks 1,2,4,6 ]
  5. Rescue medication use [ Time Frame: Weeks 1,2,3,4,5,6 ]
  6. Profile of Mood States (POMS) [ Time Frame: Baseline to weeks 1,2,4,6 ]
  7. Daily Sleep Interference Scale [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
  8. Short Form 36 (SF-36) [ Time Frame: Baseline to week 6 ]
  9. Safety and tolerability [ Time Frame: Baseline, weeks 1,2,3,4,5,6,7,12 ]
    Adverse events, ECG, labs

  10. Relationship of plasma concentrations [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
  11. Time to a 30% reduction in average daily pain score [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
  12. Time to a 50% reduction in average daily pain score [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
  13. Subjects who have greater than or equal to a 30% reduction in average daily pain score [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
  14. Subjects who have greater than or equal to a 50% reduction in average daily pain score [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. 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)

4. At screening, the subject has an average daily pain score for neuropathic pain due to LSR of ≥ 3 and ≤ 8 on the PI-NRS.

5. 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).

Exclusion Criteria:

  1. 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.

  2. 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).
  3. The subject has pain in the lower limbs solely upon walking and not at rest.
  4. 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.
  5. 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.
  6. 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
    • Hepatic disease
    • Respiratory disease
    • Renal disease
    • Any condition that is known to interfere with the absorption, distribution, metabolism, or excretion of drugs
  7. The subject has a history of or currently has:

    • Any clinically significant vital sign, ECG, or laboratory abnormalities.
    • QTcF >450 msec (males) or >470 msec (females)
  8. The subject had a malignancy.
  9. The subject has had a positive test for HIV antibody or a history of HIV.
  10. The subject has had a positive test for hepatitis B surface antigen or hepatitis C antibody.
  11. The subject has a history of AST, ALT or bilirubine >2 times the upper limit of normal.
  12. The subject has a history of hypersensitivity to calcium channel blockers.
  13. The subject has a history of multiple drug allergies (≥ 2 kinds) that, in the investigator's opinion, may place him or her at greater risk during participation in the study.
  14. The subject has participated in a previous clinical study of Z160 or has received another investigational drug ≤ 30 days before the screening visit.
  15. The subject has taken a prohibited medication ≤ 30 days before the screening visit.
  16. The subject has a history of alcohol or narcotic substance abuse, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), ≤ 1 year before the screening visit.
  17. The subject has a positive urine drug test at screening.
  18. The subject is female and is pregnant or breastfeeding at the time of the screening visit or plans to become pregnant during the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01655849

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United States, Alabama
Investigative Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Investigative Site
Peoria, Arizona, United States, 85381
United States, California
Investigative Site
Anaheim, California, United States, 92804
Investigative Site
Fresno, California, United States, 93726
Investigative Site
Orange, California, United States, 92868
Investigative Site
Sacramento, California, United States, 95821
United States, Florida
Investigative Site
Clearwater, Florida, United States, 33756
Investigative Site
Clearwater, Florida, United States, 33765
Investigative Site
Orlando, Florida, United States, 32806
Investigative Site
Pinellas Park, Florida, United States, 33781
Investigative Site
Plantation, Florida, United States, 33317
Investigative Site
Royal Palm Beach, Florida, United States, 33411
United States, Georgia
Investigative Site
Atlanta, Georgia, United States, 30342
United States, Kansas
Investigative Site
Overland Park, Kansas, United States, 66210
United States, Louisiana
Investigative Site
Shreveport, Louisiana, United States, 71105
United States, Massachusetts
Investigative Site
Boston, Massachusetts, United States, 02135
United States, Missouri
Investigative Site
Hazelwood, Missouri, United States, 63042
United States, Nevada
Investigative Site
Las Vegas, Nevada, United States, 89144
United States, Oregon
Investigative Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Investigative Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Investigative Site
Dallas, Texas, United States, 75230
United States, Utah
Investigative Site
Sandy, Utah, United States, 84070
United States, Washington
Investigative Site
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
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Study Director: Margaret Lee, PhD Zalicus Inc
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Responsible Party: Zalicus Identifier: NCT01655849    
Other Study ID Numbers: Z160-LSR-201
First Posted: August 2, 2012    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases