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

UCB

Status and phase: Completed; Phase 2

Conditions: Neuralgia, Postherpetic

Treatments: Drug: Brivaracetam; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160667

2004-000975-32 (EudraCT Number)

N01162

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo tablets administered twice a day.

Treatment:

Drug: Placebo

Brivaracetam 200 mg/day

Experimental group

Description:

Brivaracetam 200 mg/day (100 mg administered twice a day).

Treatment:

Drug: Brivaracetam

Brivaracetam 400 mg/day

Experimental group

Description:

Brivaracetam 400 mg/day (200 mg administered twice a day).

Treatment:

Drug: Brivaracetam