A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)
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| ClinicalTrials.gov Identifier: NCT00160667 |
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Recruitment Status :
Completed
First Posted : September 12, 2005
Results First Posted : January 31, 2019
Last Update Posted : January 31, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neuralgia, Postherpetic | Drug: Placebo Drug: Brivaracetam | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 152 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | October 11, 2004 |
| Actual Primary Completion Date : | January 5, 2006 |
| Actual Study Completion Date : | January 5, 2006 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Matching placebo tablets administered twice a day.
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Drug: Placebo
Daily oral dose of two equal intakes. |
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Experimental: Brivaracetam 200 mg/day
Brivaracetam 200 mg/day (100 mg administered twice a day).
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Drug: Brivaracetam
Daily oral dose of two equal intakes.
Other Name: Briviact |
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Experimental: Brivaracetam 400 mg/day
Brivaracetam 400 mg/day (200 mg administered twice a day).
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Drug: Brivaracetam
Daily oral dose of two equal intakes.
Other Name: Briviact |
- Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period [ Time Frame: Baseline, 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.
- Responder Rate in Average Pain Intensity Score at the Last Week of the Treatment Period Compared to the Baseline Period [ Time Frame: Baseline, last week of the 4-week Treatment 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 [ Time Frame: Baseline, each Evaluation visit (up to Week 4) ]
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.
- Percent Change From the Baseline Period to the Last Week of the Treatment Period in the Sleep Interference Score [ Time Frame: Baseline, last assessment during the 4-week Treatment Period ]
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 [ Time Frame: Baseline, each Evaluation visit (up to Week 4) ]
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.
- 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) [ Time Frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) ]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) [ Time Frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) ]
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) [ Time Frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) ]
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 [ Time Frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) ]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 [ Time Frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) ]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 [ Time Frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) ]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 [ Time Frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) ]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 [ Time Frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) ]
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 [ Time Frame: Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4) ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160667
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| Study Director: | UCB Cares | +1 844 599 2273 (UCB) |
| Responsible Party: | UCB |
| ClinicalTrials.gov Identifier: | NCT00160667 |
| Other Study ID Numbers: |
N01162 2004-000975-32 ( EudraCT Number ) |
| First Posted: | September 12, 2005 Key Record Dates |
| Results First Posted: | January 31, 2019 |
| Last Update Posted: | January 31, 2019 |
| Last Verified: | August 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Post-herpetic Neuralgia (PHN) Brivaracetam |
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Neuralgia Neuralgia, Postherpetic Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |
Pain Neurologic Manifestations Brivaracetam Anticonvulsants |