Clinical trial NCT00160667: A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)
Official title: An Exploratory, Double Blind, Randomized, Placebo-controlled, Parallel Group, Multicenter Study, for the Assessment of Efficacy, Safety and Tolerability of Ucb 34714 50 mg Oral Capsules in b.i.d. Administration at the Doses of 200 mg/Day and 400 mg/Day, in Subjects (at Least 18 Years Old) Suffering From Post Herpetic Neuralgia (PHN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuralgia, Postherpetic
Keywords: Post-herpetic Neuralgia (PHN)
Brivaracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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:

Primary outcomes:
measure: Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period
timeFrame: Baseline, last week of the 4-week Treatment Period
Secondary outcomes:
measure: Responder Rate in Average Pain Intensity Score at the Last Week of the Treatment Period Compared to the Baseline Period
timeFrame: Baseline, last week of the 4-week Treatment Period
measure: Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score
timeFrame: Baseline, each Evaluation visit (up to Week 4)
measure: Percent Change From the Baseline Period to the Last Week of the Treatment Period in the Sleep Interference Score
timeFrame: Baseline, last assessment during the 4-week Treatment Period
measure: Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score
timeFrame: Baseline, each Evaluation visit (up to Week 4)
measure: 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)
timeFrame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
measure: Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Sensory Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
measure: Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Affective Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
measure: Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Present Pain Intensity (PPI) Score of the SF-MPQ
timeFrame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
measure: Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Visual Analog Scale (VAS) of the SF-MPQ
timeFrame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
measure: Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
timeFrame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
measure: Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit
timeFrame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
measure: Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Intensity Rated by the Patient
timeFrame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
measure: Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Area Measured by the Investigator
timeFrame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)
Other outcomes:
Locations:
city: Brussels
country: Belgium
city: Eeklo
country: Belgium
city: Genk
country: Belgium
city: Liege
country: Belgium
city: Lubbeek (Pellenberg)
country: Belgium
city: Pleven
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Hradec Kralove
country: Czechia
city: Prague
country: Czechia
city: Svitavy
country: Czechia
city: Usti nad Labem
country: Czechia
city: Annecy
country: France
city: Clermont-Ferrand Cedex
country: France
city: Nice Cedex 1
country: France
city: Toulouse
country: France
city: Voiron
country: France
city: Bad Worishofen
country: Germany
city: Bochum
country: Germany
city: Essen
country: Germany
city: Kassel
country: Germany
city: Rodgau
country: Germany
city: Gdansk
country: Poland
city: Grudziadz
country: Poland
city: Katowice
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Olsztyn
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Zgierz
country: Poland
city: Belgarde
country: Serbia
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Bratislava
country: Slovakia
city: Dubnica nad Vahom
country: Slovakia
city: Kosice
country: Slovakia
city: Nitra
country: Slovakia
city: Cadiz
country: Spain
city: Granada
country: Spain
city: Hospitalet de Llobregat (Barcelona)
country: Spain
city: Madrid
country: Spain
city: Sant Cugat Del Valles (Barcelona)
country: Spain
city: Valencia
country: Spain
city: Bath
country: United Kingdom
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: Winchester
country: United Kingdom
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: