Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia

Pfizer

Status and phase

Terminated

Phase 4

Conditions

Postherpetic Neuralgia

Treatments

Drug: pregabalin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01603394

A9001464

Details and patient eligibility

About

The primary objective is to explore whether sensory symptom cluster analysis is useful for predicting treatment response in Postherpetic Neuralgia.

Full description

The study was stopped on 26 April 2013 due to feasibility issues (low enrollment) not safety. The overall risk-benefit of Lyrica has not changed at all due to termination of this trial. Only 9 of the 150 patients were enrolled into the trial, so we are unable to get adequate results from this study.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
At screening (V1) and baseline (V2), subjects must have a score of >=4 on the Numeric Rating Scale for Pain (1 week recall period).
At baseline (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be >=4.

Exclusion criteria

Subjects having other severe pain that may confound assessment or self evaluation of the pain due to PHN.
Neurolytic or neurosurgical therapy for Postherpetic Neuralgia
Skin conditions in the affected dermatome that could alter sensation.