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

Postherpetic Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00813826
• Other study ID #: SLC022/201
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 19, 2008
• Last updated: July 29, 2009
• Start date: January 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2009
• Source: Solace Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 204
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• SLC022
SLC022 150 mg capsule, 900mg daily dose
• Placebo
Placebo capsule, TID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Solace Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No