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

NCT00160667 | Completed Phase 2 Results

• 2 other identifiers: N011622004-000975-32
• Study Type: interventional
• Target: 152
• Locations: 10 countries
• Sites: 50

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.

Conditions

Neuralgia, Postherpetic

Keywords

Post-herpetic Neuralgia (PHN); Brivaracetam

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, last week of the 4-week Treatment Period

Secondary Outcomes (13)

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

  Baseline, last week of the 4-week Treatment Period

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

  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

  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

  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)

  Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Matching placebo tablets administered twice a day.

Drug: Placebo

Brivaracetam 200 mg/day

EXPERIMENTAL

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

Drug: Brivaracetam

Brivaracetam 400 mg/day

EXPERIMENTAL

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

Drug: Brivaracetam

Interventions

Placebo DRUG

Daily oral dose of two equal intakes.

Placebo

Brivaracetam DRUG

Daily oral dose of two equal intakes.

Also known as: Briviact

Brivaracetam 200 mg/day; Brivaracetam 400 mg/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (50)

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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

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Svitavy, Czechia

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Ústí nad Labem, Czechia

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Annecy, France

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Clermont-Ferrand, France

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Nice, France

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Toulouse, France

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Voiron, France

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Bad Wörishofen, Germany

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Bochum, Germany

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Essen, Germany

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Kassel, Germany

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Rodgau, Germany

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Gdansk, Poland

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Grudziądz, Poland

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Katowice, Poland

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Kielce, Poland

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Krakow, Poland

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Lublin, Poland

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Olsztyn, Poland

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Poznan, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Zgierz, Poland

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Belgarde, Serbia

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Belgrade, Serbia

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Kragujevac, Serbia

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Bratislava, Slovakia

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Dubnica nad Váhom, Slovakia

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Košice, Slovakia

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Nitra, Slovakia

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Cadiz, Spain

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Granada, Spain

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Hospitalet de Llobregat (Barcelona), Spain

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Madrid, Spain

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Sant Cugat Del Valles (Barcelona), Spain

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Valencia, Spain

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Bath, United Kingdom

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Glasgow, United Kingdom

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London, United Kingdom

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Winchester, United Kingdom

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Related Links

• Product Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844599

Study Officials

• UCB Cares

  +1 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: October 11, 2004
• Primary Completion: January 5, 2006
• Study Completion: January 5, 2006
• Last Updated: January 31, 2019
• Results First Posted: January 31, 2019

Record last verified: 2018-08

Locations

BU (3); ES (6); GB (4); CZ (4); BE (5); SL (4); FR (5); SE (3); DE (5); PL (11)