Efficacy and Safety Study of SLC022 in Treating Pain Associated With Post Herpetic Neuralgia

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Tolerability of Oral SLC022 300 mg TID, a Glial Cell Modulating Agent, Versus Placebo in the Treatment of Post Herpetic Neuralgia

The purpose of this study is to evaluate the efficacy and safety of SLC022 in treating pain associated with post-herpetic neuralgia (PHN) in recently diagnosed patients.

Study Overview

• Status: Unknown
• Conditions: Postherpetic Neuralgia
• Intervention / Treatment: Drug: SLC022; Drug: Placebo

Detailed Description

This study will enroll subjects with established PHN, a stable pain intensity and that meet all other eligibility criteria.

• Study Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Sierra Vista, Arizona, United States, 85635
  • California
    • Mission Viejo, California, United States, 92691
  • Florida
    • Orlando, Florida, United States, 32806
    • Plantation, Florida, United States, 33324
  • Georgia
    • Marietta, Georgia, United States, 30060
  • Illinois
    • Oak Brook, Illinois, United States, 60523
  • Louisiana
    • Shreveport, Louisiana, United States, 71030
  • Massachusetts
    • Brockton, Massachusetts, United States, 20301
  • Nebraska
    • Omaha, Nebraska, United States, 68134
  • New York
    • Rochester, New York, United States, 14618
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
  • Ohio
    • Kettering, Ohio, United States, 45429
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
    • Philadelphia, Pennsylvania, United States, 19139
    • West Reading, Pennsylvania, United States, 19611
  • Texas
    • Dallas, Texas, United States, 75230
    • Houston, Texas, United States, 77074
    • San Antonio, Texas, United States, 78229
  • Utah
    • Midvale, Utah, United States, 84047

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. Well established consistent pain during baseline phase.
4. Completed a washout period of 7 days for existing pain medications.
5. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
6. A willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

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.
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.
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 other than basal cell carcinoma and carcinoma in situ.
13. History of chronic hepatitis B or C, or human immunodeficiency virus (HIV) infection.
14. Clinically significant hepatic, respiratory, hematological, cardiovascular or neurological disease.
15. Immunocompromised state.
16. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SLC022; 300mg TID	Drug: SLC022; SLC022 150 mg capsule, 900mg daily dose; Drug: Placebo; Placebo capsule, TID
Placebo Comparator: Placebo; Matching placebo capsule	Drug: Placebo; Placebo capsule, TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint of this study is the change in a subject's mean pain score from the baseline period to the end of the treatment period as measured using the 11-point Numerical Rating Scale.	7 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Determining the safety and tolerability of SLC022 300 mg TID compared to placebo TID in subjects with PHN by measuring changes in vital signs, ECG, hematology and other laboratory values, and subject-reported adverse events.	7 weeks

Collaborators and Investigators

• Sponsor: Solace Pharmaceuticals
• Investigators: Study Director: Kevin Pojasek, PhD, Solace Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): October 1, 2009
• Study Completion (Anticipated): November 1, 2009

Study Registration Dates

• First Submitted: December 19, 2008
• First Submitted That Met QC Criteria: December 22, 2008
• First Posted (Estimate): December 23, 2008

Study Record Updates

• Last Update Posted (Estimate): July 30, 2009
• Last Update Submitted That Met QC Criteria: July 29, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: PHN; Pain after Shingles
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic
• Other Study ID Numbers: SLC022/201