Status:
COMPLETED
A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)
Lead Sponsor:
UCB Pharma
Conditions:
Neuralgia, Postherpetic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2006
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00160667
Start Date
October 11 2004
End Date
January 5 2006
Last Update
January 31 2019
Active Locations (50)
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1
Brussels, Belgium
2
Eeklo, Belgium
3
Genk, Belgium
4
Liège, Belgium