Overview

A Study In Patients With Neuropathic Pain From Post-Herpetic Neuralgia (PHN)

Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with post-herpetic neuralgia (PHN).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
XenoPort, Inc.
Treatments:
Gabapentin
gamma-Aminobutyric Acid
Criteria
Inclusion Criteria:

- 18 years or older

- Female subjects are eligible if of non-childbearing potential or not lactating, has a
negative pregnancy, and agrees to use one a specified highly effective method for
avoiding pregnancy

- Documented medical diagnosis of PHN of with pain present for at least three months
from the healing of a herpes zoster rash

- Baseline 24-hour average pain intensity score ≥ 4.0 based on an 11-point PI-NRS

- Provides written informed consent in accordance with all applicable regulatory
requirements

Exclusion Criteria:

- Other chronic pain conditions not associated with PHN. However, the subject will not
be excluded if:

- The pain is located at a different region of the body; and

- The pain intensity is not greater than the pain intensity of the PHN; and

- The subject can assess PHN pain independently of other pain

- Is unable to discontinue prohibited medications or non-drug therapies or procedures
throughout the duration of the study

- Hepatic impairment defined as ALT or AST > 2x upper limit of normal (ULN), or alkaline
phosphatase or bilirubin > 1.5x ULN

- Chronic hepatitis B or C

- Impaired renal function defined as creatinine clearance <60 mL/min or requiring
hemodialysis

- Corrected QT (QTc) interval ≥ 450 msec or QTc interval ≥480 msec for patients with
Bundle Branch Block

- Uncontrolled hypertension at screen (sitting systolic >160 mmHg and/or sitting
diastolic >90 mmHg)

- Current diagnosis of active epilepsy or any active seizure disorder requiring chronic
therapy with antiepileptic drugs

- Medical condition or disorder that would interfere with the action, absorption,
distribution, metabolism, or excretion of GEn, or, in the investigator's judgment

- Is considered to be clinically significant and may pose a safety concern, or,

- Could interfere with the accurate assessment of safety or efficacy, or,

- Could potentially affect a subject's safety or study outcome

- Meets criteria defined by the DSM-IV-TR for a major depressive episode or for active
significant psychiatric disorders within last year

- Depression in remission, with or without antidepressant treatment, may participate,
unless stable antidepressant regimen is a prohibited medication

- Antidepressant medication may not be changed or discontinued to meet entry criteria
and must be stable for at least three months prior to enrollment

- History of clinically significant drug or alcohol abuse (DSM-IV-TR) or is unable to
refrain from substance abuse throughout the study. Benzodiazepines or atypical
benzodiazepines as hypnotic sleep agents permitted.

- Currently participating in another clinical study in which the subject is, or will be
exposed to an investigational or non-investigational drug or device

- Has participated in a clinical study and was exposed to investigational or
non-investigational drug or device:

- Within preceding month for studies unrelated to PHN, or

- Within preceding six months for studies related to PHN

- Treated previously with GEn

- History of allergic or medically significant adverse reaction to investigational
products (including gabapentin) or their excipients, acetaminophen or related
compounds