A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)
NCT ID: NCT00160667
Last Updated: 2019-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
152 participants
INTERVENTIONAL
2004-10-11
2006-01-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matching placebo tablets administered twice a day.
Placebo
Daily oral dose of two equal intakes.
Brivaracetam 200 mg/day
Brivaracetam 200 mg/day (100 mg administered twice a day).
Brivaracetam
Daily oral dose of two equal intakes.
Brivaracetam 400 mg/day
Brivaracetam 400 mg/day (200 mg administered twice a day).
Brivaracetam
Daily oral dose of two equal intakes.
Interventions
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Placebo
Daily oral dose of two equal intakes.
Brivaracetam
Daily oral dose of two equal intakes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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UCB
Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273 (UCB)
Locations
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Brussels, , Belgium
Eeklo, , Belgium
Genk, , Belgium
Liège, , Belgium
Lubbeek (Pellenberg), , Belgium
Pleven, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Hradec Králové, , Czechia
Prague, , Czechia
Svitavy, , Czechia
Ústí nad Labem, , Czechia
Annecy, , France
Clermont-Ferrand, , France
Nice, , France
Toulouse, , France
Voiron, , France
Bad Wörishofen, , Germany
Bochum, , Germany
Essen, , Germany
Kassel, , Germany
Rodgau, , Germany
Gdansk, , Poland
Grudziądz, , Poland
Katowice, , Poland
Kielce, , Poland
Krakow, , Poland
Lublin, , Poland
Olsztyn, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Zgierz, , Poland
Belgarde, , Serbia
Belgrade, , Serbia
Kragujevac, , Serbia
Bratislava, , Slovakia
Dubnica nad Váhom, , Slovakia
Košice, , Slovakia
Nitra, , Slovakia
Cadiz, , Spain
Granada, , Spain
Hospitalet de Llobregat (Barcelona), , Spain
Madrid, , Spain
Sant Cugat Del Valles (Barcelona), , Spain
Valencia, , Spain
Bath, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Winchester, , United Kingdom
Countries
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Related Links
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Product Information
FDA Safety Alerts and Recalls
Other Identifiers
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2004-000975-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01162
Identifier Type: -
Identifier Source: org_study_id
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