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

Primary Purpose

Neuralgia, Postherpetic

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

Brivaracetam

About this trial

This is an interventional treatment trial for Neuralgia, Postherpetic focused on measuring Post-herpetic Neuralgia (PHN), Brivaracetam

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Brivaracetam 200 mg/day

Brivaracetam 400 mg/day

Arm Description

Matching placebo tablets administered twice a day.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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.

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

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.

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)

The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The sensory score ranges from 0 to 33. Change = observation mean at Evaluation / Early Discontinuation visit minus Randomization mean. A negative value in absolute change indicates an improvement.

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)

The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The affective score ranges from 0 to 12. Change = observation mean at Evaluation / Early Discontinuation visit minus Randomization mean. A negative value in absolute change indicates an improvement.

Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Present Pain Intensity (PPI) Score of the SF-MPQ

Present pain intensity (PPI) was rated by the subject. The score ranges from 0 (no pain) to 5 (excruciating). A negative value in absolute change indicates an improvement in PPI.

Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Visual Analog Scale (VAS) of the SF-MPQ

Pain burden was rated by the subject using the visual analog scale (VAS) ranging from 0 (no pain) to 100 (worst possible pain). A negative value in absolute change indicates an improvement in pain burden.

Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit

Patient´s global assessment of change in pain was performed using a seven-point scale (7= Marked improvement, 6= Moderate improvement, 5= Slight improvement, 4= No change, 3= Slight worsening, 2= Moderate worsening, 1= Marked worsening).

Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit

Investigator´s global assessment of change was performed using a seven-point scale (7= Marked improvement, 6= Moderate improvement, 5= Slight improvement, 4= No change, 3= Slight worsening, 2= Moderate worsening, 1= Marked worsening).

Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Intensity Rated by the Patient

Brush-evoked allodynia intensity was assessed by the subject on an 11-point numerical rating scale, ranging from 0= no pain to 10= unbearable Pain. A negative value in percent change indicates an improvement in brush-evoked allodynia intensity.

Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Area Measured by the Investigator

Allodynia is pain due to a normally non-painful stimulus. The brush-evoked allodynia areas were assessed by the Investigator (location and contour of the allodynic regions drawn on a standard dermatomal map). Areas (mm²) of the allodynic regions drawn by the Investigator were afterwards computed by means of appropriate tools and calibrated templates. The larger the area in square centimeters the more allodynia. A negative value in percent change in the brush-evoked allodynia area indicates improvement.

Full Information

NCT ID

NCT00160667

First Posted

September 8, 2005

Last Updated

August 21, 2018

Sponsor

UCB Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00160667

Brief Title

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

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

October 11, 2004 (Actual)

Primary Completion Date

January 5, 2006 (Actual)

Study Completion Date

January 5, 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

UCB Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuralgia, Postherpetic

Keywords

Post-herpetic Neuralgia (PHN), Brivaracetam

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

152 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo tablets administered twice a day.

Arm Title

Brivaracetam 200 mg/day

Arm Type

Experimental

Arm Description

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

Arm Title

Brivaracetam 400 mg/day

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Daily oral dose of two equal intakes.

Intervention Type

Drug

Intervention Name(s)

Brivaracetam

Other Intervention Name(s)

Briviact

Intervention Description

Daily oral dose of two equal intakes.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, last week of the 4-week Treatment Period

Secondary Outcome Measure Information:

Title

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

Description

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

Title

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

Description

Time Frame

Baseline, each Evaluation visit (up to Week 4)

Title

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

Description

Time Frame

Baseline, last assessment during the 4-week Treatment Period

Title

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

Description

Time Frame

Baseline, each Evaluation visit (up to Week 4)

Title

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)

Description

Time Frame