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This study will compare Z160 and placebo in patients with Lumbosacral Radiculopathy for safety and efficacy for a period of 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Z160 | Experimental | 375mg BID |
|
| placebo | Placebo Comparator | matching placebo control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| z160 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weekly average of daily pain scores (PI-NRS) | Baseline to week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
The subject must have a diagnosis of pain due to LSR, with all of the following characteristics:
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:
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:
The subject has:
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:
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:
The subject has a history of or currently has:
The subject had a malignancy.
The subject has had a positive test for HIV antibody or a history of HIV.
The subject has had a positive test for hepatitis B surface antigen or hepatitis C antibody.
The subject has a history of AST, ALT or bilirubine >2 times the upper limit of normal.
The subject has a history of hypersensitivity to calcium channel blockers.
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.
The subject has participated in a previous clinical study of Z160 or has received another investigational drug ≤ 30 days before the screening visit.
The subject has taken a prohibited medication ≤ 30 days before the screening visit.
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.
The subject has a positive urine drug test at screening.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Lee, PhD | Zalicus Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Huntsville | Alabama | 35801 | United States | ||
| Investigative Site |
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|
| 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 |
| 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 | Adverse events, ECG, labs | 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 |
| Peoria |
| Arizona |
| 85381 |
| United States |
| Investigative Site | Anaheim | California | 92804 | United States |
| Investigative Site | Fresno | California | 93726 | United States |
| Investigative Site | Orange | California | 92868 | United States |
| Investigative Site | Sacramento | California | 95821 | United States |
| Investigative Site | Clearwater | Florida | 33756 | United States |
| Investigative Site | Clearwater | Florida | 33765 | United States |
| Investigative Site | Orlando | Florida | 32806 | United States |
| Investigative Site | Pinellas Park | Florida | 33781 | United States |
| Investigative Site | Plantation | Florida | 33317 | United States |
| Investigative Site | Royal Palm Beach | Florida | 33411 | United States |
| Investigative Site | Atlanta | Georgia | 30342 | United States |
| Investigative Site | Overland Park | Kansas | 66210 | United States |
| Investigative Site | Shreveport | Louisiana | 71105 | United States |
| Investigative Site | Boston | Massachusetts | 02135 | United States |
| Investigative Site | Hazelwood | Missouri | 63042 | United States |
| Investigative Site | Las Vegas | Nevada | 89144 | United States |
| Investigative Site | Medford | Oregon | 97504 | United States |
| Investigative Site | Duncansville | Pennsylvania | 16635 | United States |
| Investigative Site | Dallas | Texas | 75230 | United States |
| Investigative Site | Sandy City | Utah | 84070 | United States |
| Investigative Site | Bellevue | Washington | 98007 | United States |
| ID | Term |
|---|---|
| C000629484 | Z160 |
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