NCT00160667已完成2 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 152
- 主要终点
- Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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:
研究组 & 干预措施
Placebo
Placebo Comparator
Matching placebo tablets administered twice a day.
干预措施: Placebo (Drug)
Brivaracetam 200 mg/day
Experimental
Brivaracetam 200 mg/day (100 mg administered twice a day).
干预措施: Brivaracetam (Drug)
Brivaracetam 400 mg/day
Experimental
Brivaracetam 400 mg/day (200 mg administered twice a day).
干预措施: Brivaracetam (Drug)
结局指标
主要结局
Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period
时间窗: 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.
次要结局
- 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)
- 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))
- Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Visual Analog Scale (VAS) of the SF-MPQ(Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4))
- Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit(Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4))
- 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)(Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4))
- 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 Sensory Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)(Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4))
- Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Present Pain Intensity (PPI) Score of the SF-MPQ(Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4))
- Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit(Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4))
- Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Area Measured by the Investigator(Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4))
- Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Intensity Rated by the Patient(Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4))
研究者
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