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
1 other identifier
interventional
204
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2009
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2008
CompletedFirst Posted
Study publicly available on registry
December 23, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedJuly 30, 2009
July 1, 2009
9 months
December 19, 2008
July 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
SLC022
EXPERIMENTAL300mg TID
Placebo
PLACEBO COMPARATORMatching placebo capsule
Interventions
Eligibility Criteria
You may qualify if:
- Male or female age 18 years or older.
- 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.
- Well established consistent pain during baseline phase.
- Completed a washout period of 7 days for existing pain medications.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- A willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
You may not qualify if:
- Pregnant or breast feeding.
- 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.
- Previous neurolytic or neurosurgical therapy for PHN.
- Treatment with local anesthetic nerve blocks within the last 30 days.
- Failure of an adequate dose of 3 or more first line drug treatments for PHN-related pain due to efficacy.
- Any other type of pain which may impair the self assessment of the pain due to PHN.
- Skin conditions in the affected dermatome that could alter sensation.
- Participation in other studies within 30 days before the current study begins and/or during study participation.
- Taking CYP1A2 inhibitors such as fluvoxamine, certain fluoroquinolones (e.g., ciprofloxacin, enoxacin, pefloxacin, etc), mexiletine, and zileuton.
- History of drug or alcohol abuse during the last 5 years.
- Creatinine clearance \<50 mL/min.
- History of malignancy other than basal cell carcinoma and carcinoma in situ.
- History of chronic hepatitis B or C, or human immunodeficiency virus (HIV) infection.
- Clinically significant hepatic, respiratory, hematological, cardiovascular or neurological disease.
- Immunocompromised state.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Sierra Vista, Arizona, 85635, United States
Unknown Facility
Mission Viejo, California, 92691, United States
Unknown Facility
Orlando, Florida, 32806, United States
Unknown Facility
Plantation, Florida, 33324, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Unknown Facility
Oak Brook, Illinois, 60523, United States
Unknown Facility
Shreveport, Louisiana, 71030, United States
Unknown Facility
Brockton, Massachusetts, 20301, United States
Unknown Facility
Omaha, Nebraska, 68134, United States
Unknown Facility
Rochester, New York, 14618, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Kettering, Ohio, 45429, United States
Unknown Facility
Altoona, Pennsylvania, 16602, United States
Unknown Facility
Philadelphia, Pennsylvania, 19139, United States
Unknown Facility
West Reading, Pennsylvania, 19611, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Midvale, Utah, 84047, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kevin Pojasek, PhD
Solace Pharmaceuticals Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 19, 2008
First Posted
December 23, 2008
Study Start
January 1, 2009
Primary Completion
October 1, 2009
Study Completion
November 1, 2009
Last Updated
July 30, 2009
Record last verified: 2009-07