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

UCB Pharma152 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

152

Conditions

Neuralgia, Postherpetic

Interventions

PlaceboDRUG

Daily oral dose of two equal intakes.

BrivaracetamDRUG

Daily oral dose of two equal intakes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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:

Locations (50)

Outcomes

Primary Outcomes

Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period

Pain intensity was scored on a 11-point numeric pain rating scale, ranging from 0 to 10 where 0= no pain and 10= worst possible pain. A negative value in percent change from Baseline indicates a decrease in average pain intensity score from Baseline.

Time frame: Baseline, last week of the 4-week Treatment Period

Secondary Outcomes

Responder Rate in Average Pain Intensity Score at the Last Week of the Treatment Period Compared to the Baseline Period

A responder is defined as a subject with a \>= 30 % reduction in average pain intensity score at the Evaluation Week (last week of the Treatment Period) compared to the Baseline Period.

Time frame: Baseline, last week of the 4-week Treatment Period

Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score

Time frame: Baseline, each Evaluation visit (up to Week 4)

Percent Change From the Baseline Period to the Last Week of the Treatment Period in the Sleep Interference Score

Sleep interference was scored on a 11-point numerical sleep interference rating scale, ranging from 0 to 10 where 0 = 'pain does not interfere with sleep', 10 = 'pain completely interferes with sleep'. A negative value in percent change from Baseline indicates a decrease in average sleep interference score from Baseline.

Time frame: Baseline, last assessment during the 4-week Treatment Period

Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score

Data from ClinicalTrials.gov

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Brussels, Belgium

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Eeklo, Belgium

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Genk, Belgium

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Liège, Belgium

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Lubbeek (Pellenberg), Belgium

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Pleven, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Hradec Králové, Czechia

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Prague, Czechia

...and 40 more locations

Time frame: Baseline, each Evaluation visit (up to Week 4)

Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Total Pain Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)

The SF-MPQ has three components: the first one consists of 15 subscales (descriptors: 11 sensory, 4 affective) which are rated on an intensity scale with 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total subscales (descriptors). The SF-MPQ also includes a Present Pain Intensity (PPI) index and a visual analogue scale (VAS). Each of the 15 subscales is rated from 0=none to 3=severe pain. The Total Pain Score of the SF-MPQ is the sum of all 15 ratings and can hence vary from 0 (15\*0=0: no pain) to 60 (15\*4=60: severe pain). The mean change in total score is reported.