Overview

A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)

Status:
Completed

Trial end date:
2006-01-05

Target enrollment:
0

Participant gender:
All

Summary

Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor down-titration.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

UCB Pharma

Treatments:

Brivaracetam

Criteria

Inclusion Criteria:

Inclusion Criteria:

- Male/female subject aged 18 years or older.

- Pain present for at least 6 months after healing of the acute herpes zoster skin rash.

- Pain intensity score assessed on an 11-point numerical pain rating scale with a score
of at least 4 at the screening visit and with an average weekly score of at least 4 on
an 11-point numerical pain rating scale during baseline period.

Exclusion Criteria:

- Subject getting any kind of psychological support to help cope with pain such as
biofeedback or behavioral cognitive therapy.

- Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy
for post-herpetic neuralgia (PHN) or who receives trans-electrical neural stimulation
(TENS.

- Tricyclic antidepressants (TCAs) or non-steroidal anti-inflammatory drug (NSAIDs) or
permitted opioid analgesics ('strong' opioids are forbidden) that started less than 30
days and/or are not stabilized prior to screening and/or are not expected to be kept
stable during the study.

- Intake of more than two pain treatments at trial entry (screening visit) including
Tricyclic antidepressants (TCAs), non-steroidal anti-inflammatory drugs (NSAIDs) or
permitted opioid analgesics.

- Subject being treated with Carbamazepine for any indication.

- Known coexistent source of painful peripheral neuropathy or other systemic disease
associated with a secondary painful neuropathy.

- Subject being treated in the four weeks prior to screening visit with 'strong' opioid
analgesics.

Exclusion Criteria: