Phase 2
N=152
A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)
Neuralgia, Postherpetic
Bottom Line
View on ClinicalTrials.gov: NCT00160667 ↗Enrolled (actual)
152
Serious AEs
0.7%
Results posted
Jan 2019
Primary outcome: Primary: Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period — -26.16; -26.11; -27.36 percentage of change — p==0.965
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Brivaracetam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Jan 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period |
-26.16; -26.11; -27.36 | =0.965 |
| SECONDARY Responder Rate in Average Pain Intensity Score at the Last Week of the Treatment Period Compared to the Baseline Period |
33.3; 37.3; 40.0 | — |
| SECONDARY Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score |
-10.3; -5.2; -8.5; -20.8; -10.5; -18.7 | — |
| SECONDARY Percent Change From the Baseline Period to the Last Week of the Treatment Period in the Sleep Interference Score |
-42.00; -23.33; -30.17 | — |
| SECONDARY Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score |
-13.06; -6.96; -18.01; -33.28; -5.69; -27.38 | — |
| SECONDARY 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) |
-3.44; -4.65; -4.62 | — |
| SECONDARY 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) |
-2.42; -3.79; -4.17 | — |
| SECONDARY 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) |
-1.04; -0.70; -0.75 | — |
| SECONDARY Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Present Pain Intensity (PPI) Score of the SF-MPQ |
-0.7; -0.6; -0.9 | — |
| SECONDARY Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Visual Analog Scale (VAS) of the SF-MPQ |
-13.1; -15.5; -17.9 | — |
| SECONDARY Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit |
14.9; 9.8; 23.4; 29.8; 27.5; 27.7 | — |
| SECONDARY Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit |
10.2; 9.8; 17.6; 28.6; 23.5; 23.5 | — |
| SECONDARY Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Intensity Rated by the Patient |
-27.4; -12.9; -18.2 | — |
| SECONDARY Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Area Measured by the Investigator |
-5.39; -25.18; 6.88 | — |
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
Data sourced from ClinicalTrials.gov (NCT00160667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.