Neuropathic pain including post-herpetic neuralgia, diabetic neuropathy Signs and Symptoms
Conditions
Interventions
Subjects will receive a dose of GLYX-13, a drug that controls the level of activity of NMDA receptors in the brain. All subjects will receive one dose of GLYX-13 into a vein one time each week for 12
Sponsors
Naurex, Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects 2. 18-75 years of age 3. Currently taking pain medications but pain is not adequately controlled, or currently not taking pain medication due to intolerance or lack of efficacy 4. Subjects who have experienced neuropathic pain not excluded in the exclusion criteria for 6 months or longer with pain score of 30/100 or greater by VAS at screening visit. 5. Female subjects of childbearing potential with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control (eg oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who do not plan to become pregnant during the course of the study. Female subjects may be included without a negative serum pregnancy test if they are surgically sterile or at least 2 years post-menopausal. 6. Male subjects who are abstinent during the course of the study or who use a condom during sexual intercourse. 7. Clinical laboratory values <2 times the upper limit of normal (ULN) or deemed not clinically significant per the investigator and Naurex medical monitor 8. Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assesments
Exclusion criteria
Exclusion criteria: 1. Currently hospitalized or residing in an in-patient facility during study participation 2. Substance abuse including greater than or equal to 5 units of alcohol per day where 1 unit = ½ pint of beer, 1 glass of wine 4 oz, or 1 oz. of spirits consumed most weeks or in the opinion of the investigator 3. Women who are planning to become pregnant during the course of the study 4. Participation in any clinical trial of an investigational product or device within 30 days of enrollment in this study. 5. Positive screen for drugs of abuse: cocaine, marijuana, PCP, ketamine, opioid or other agent that in the opinion of the investigator is being abused 6. Human immunodeficiency virus (HIV) infection (based on the based on the HIV-1 & HIV-2 antibody screen) or other ongoing infectious disease 7. Pain as a consequence of chemotherapeutic agent for any disease, alcohol- or HIV-induced neuropathic pain. 8. History of separate pain condition, eg, osteoarthritis that is more severe than the neuropathic pain syndrome 9. Lumbar-sacral radiculopathy or failed low back surgery 10. Pain with nerve injury expected to recover within 4 months 11. Complex regional pain syndrome type I 12. Concomitant peripheral neuropathy, paresthesia or dysthesia which cannot be differentiated from neuropathic pain due to other than neuropathic mechanism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily Assessment of Average Pain Intensity (DAPI) at the end of the study compared to the week prior to first dose of GLYX-13. The DAPI reports the worst pain during the day with pain being recorded upon waking up, at mid-day, and prior to going to bed. Pain will be rated using an 11-point scale with "0" being no pain to "10" being worst pain imaginable. | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily worst pain: 1. Change in Brief Pain Inventory (BPI), a questionnaire 2. Neuropathic Pain Symptom Inventory (NPSI), a questionnaire 3. Mean Daily Sleep Interference Score (DSIS), a scale from "0" - no interference with sleep to "10" - interferes with sleep always 4. Patient?s Global Impression of Change (PGIC), a quiestionnaire 5. Change in consumption of concomitant pain medication, writing down the other pills taken to reduce pain | — |
Countries
United States of America
Outcome results
None listed