Post herpetic neuralgia MedDRA version: 9.1 Level: LLT Classification code 10036376 Term: Post herpetic neuralgia
Conditions
Interventions
Product Name: propentofylline
Product Code: SLC022
Pharmaceutical Form: Capsule*
INN or Proposed INN: propentofylline
CAS Number: 55242-55-2
Current Sponsor code: SLC022
Other descriptive name: HWA-28
Sponsors
Solace Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female age 18 years or older. 2. A history of cutaneous herpes zoster infection and sustained pain associated with the site of the herpes zoster skin rash for >6 months, after onset of the herpes zoster skin rash. 3. Pain intensity score of =4 on an 11-point numerical rating scale for at least 5 of 7 days immediately prior to randomization. 4. Mean pain intensity of =4 on an 11-point numerical rating scale during the Baseline Phase. 5. Completion of at least 5 out of 7 daily pain reports during the Baseline Phase. 6. Completed a washout period of 7 days for any of the following medications: a2-d antagonists (e.g., gabapentin), opiate analgesics, topical lidocaine, anticonvulsants, TCAs, serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g., duloxetine), skeletal muscle relaxants, orally administered steroids, capsaicin, mexiletene, and centrally acting analgesics (dextromethorphan, tramadol). 7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 8. A willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast feeding. 2. Female subjects who are not surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least one year, or are not willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least 1 barrier method], unless sexually abstinent). 3. Previous neurolytic or neurosurgical therapy for PHN. 4. Treatment with local anesthetic nerve blocks within the last 30 days. 5. Failure of an adequate dose of 3 or more first line drug treatments for PHN-related pain due to efficacy. First line drug treatments include a2-d antagonists (gabapentin or pregabalin), SNRIs (e.g., duloxetine), the 5% lidocaine patch, opioid analgesics, tramadol hydrochloride, and TCAs. 6. Any other type of pain which may impair the self assessment of the pain due to PHN. 7. Skin conditions in the affected dermatome that could alter sensation. 8. Participation in other studies within 30 days before the current study begins and/or during study participation. 9. Taking CYP1A2 inhibitors such as fluvoxamine, certain fluoroquinolones (e.g. ciprofloxacin, enoxacin, pefloxacin, etc), mexiletine, and zileuton. 10. History of drug or alcohol abuse during the last 5 years. 11. Creatinine clearance <50 mL/min. 12. History of malignancy (< 5 years since diagnosis) other than basal cell carcinoma and carcinoma in situ. 14. History of chronic hepatitis B or C, or human immunodeficiency virus (HIV) infection. 15. Clinically significant hepatic, respiratory, hematological, cardiovascular or neurological disease. 16. Immunocompromised state. 17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of SLC022 300 mg three times daily (TID) versus placebo TID over 28 days of treatment in subjects with PHN (postherpetic neuralgia).;Secondary Objective: -- To determine the safety and tolerability of SLC022 300 mg three times daily (TID) compared to placebo TID over 28 days of treatment in subjects with PHN (postherpetic neuralgia). -- To establish a population-based pharmacokinetic (PK) model for comparing inter-subject variances in exposure.;Primary end point(s): The primary efficacy endpoint of this study is the reduction of PHN-related pain as reported on an 11-point numerical pain rating scale via the electronic subject diary. Actual values and change from baseline will be summarized by visit. The mean pain score at the end of the Treatment Phase (last 5 pain scores reported during treatment) will be compared to the mean pain score from baseline (last 5 pain scores reported prior to randomization). An Analysis of Covariance (ANCOVA) with baseline pain as a covariate will be performed on the difference in mean pain from baseline to end of treatment. Primary efficacy analysis will utilize the last observation carried forward (LOCF) imputation methodology outlined below. An observed case analysis using mixed model repeated measures (MMRM) will also be presented as a secondary sensitivity analysis. | — |
Countries
Germany
Outcome results
None listed