An Open-label Pilot Study to Collect/Evaluate Data on the Use of Consecutive Daily Intravenous Doses of Depacon in Combination With Daily Dose of Depakote ER During a Cluster Headache Cycle.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Time Required to Achieve a Greater Than or Equal to 50% Reduction in Frequency or Severity of Individual Cluster Attacks Compared to Subject-reported Baseline.
研究概览
简要总结
The purpose of this study is to collect and evaluate information on the use of Depakote Extended Release (ER) and Depacon Intravenous (IV) in patients with cluster headaches. Patients who are currently in a cluster cycle will be treated with 2 consecutive days of IV Depacon followed by oral Depakote ER. Patients will receive a total of 1,000mg of Depacon and 1,000mg of Depakote ER each day. Patients may have a 3rd day of IV Depacon followed by oral Depakote ER if the primary investigator believes it to be beneficial. The patient is then sent home on oral Depakote ER. The dose of Depakote ER can range from 500mg to 2,000mg this dose is to be determined by the primary investigator. The patient will continue the oral Depakote ER until the end of their cluster cycle or for a maximum of 6 weeks, which ever comes first.
详细描述
This study will consist of four visits (3 visits if the screening visit and first treatment visit are on the same day).
Screening Visit:
The screening visit can be performed either before an active cluster period or once the cluster period has already started. If the subject agrees to participate, the study doctor will determine if they are eligible for this study. The subject will be asked about their headache history, and medical history including all medications they are currently taking. A brief physical examination and neurologic examination will be performed and vital signs (pulse and blood pressure) will be measured. If the subject is a woman who is capable of bearing children, they will be asked to provide a urine sample for a routine pregnancy test. A blood sample (approximately 2 teaspoons) will also be obtained. Blood samples will be taken for a liver function test (LFT), complete blood count (CBC) with differential, chemistry profile, prothrombin time (PT) and partial thromboplastin time (PTT).If the screening visit is the same day as the first treatment visit, this blood work will be sent for immediate analysis. The results must be reviewed and approved by the study physician prior to the subject being administered study medication.
Treatment Visit One:
If the subject does not undergo treatment at the screening visit because they are not in an active cluster period, the subject will be asked to contact the site once their next cluster period begins. Subjects will be scheduled to come for their first treatment visit as soon as possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between the ages of 18 and 65 with a diagnosis of cluster headache (episodic or chronic) as defined by the International Headache Society criteria
- •Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
- •Subject has negative urine pregnancy test prior to study entry (Screening and Infusion Day 1), if female of child-bearing potential
- •Subject is able to understand and comply with all study requirements
- •Subject provides written informed consent prior to any screening procedures being conducted
排除标准
- •Women who are pregnant or lactating
- •Subjects who have a lifetime history of less than 2 cluster periods
- •Subjects who have a typical cluster period of less than 6 weeks duration, or are currently in a cluster period that is expected to last less than 6 weeks from Infusion Day 1
- •Subjects who have or have a history of hepatic conditions (such as hepatitis, liver failure or liver function tests (LFT's) greater than three times normal)
- •Subjects who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
- •Subjects who require a change in medication or existing regimen of medication in the 4 weeks prior to Infusion Day 1 and for the duration of the trial
- •Subjects who require a change in medication or existing regimen of medication for the prophylaxis of cluster in the 4 weeks prior to Infusion Day 1 and for the duration of the trial
- •Subjects who have used the following medications/ treatments from four weeks prior to Infusion Day 1: corticosteroids and nerve blocks.
- •Subjects who are allergic to or have shown hypersensitivity to valproate or valproic acid
- •Subjects with a history of significant drug or alcohol abuse within the past year
- •Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
- •Subjects who have failed previous trials of Depakote or Depacon for the treatment of cluster headache
研究组 & 干预措施
Depacon IV and Depakote ER
Subjects will be treated in this single arm study with 2 consecutive days of IV Depacon followed by oral Depakote ER for a total of 1000 mg of Depacon and 1000 mg of Depakote ER each day.
干预措施: Depacon IV and Depakote ER (Drug)
结局指标
主要结局
Time Required to Achieve a Greater Than or Equal to 50% Reduction in Frequency or Severity of Individual Cluster Attacks Compared to Subject-reported Baseline.
时间窗: baseline (day 0) through 47 days after first infusion
Severity: measured on an 11 point scale, where 0 = no pain and 10= excruciating pain. Outcome is time to 50% reduction in severity (or frequency) compared to baseline (prior to treatment).Frequency: Number of attacks per day.The Time to significant response was measured 2 ways: significant initial response and significant maintained response. For initial response, the time to significant response was: Mean of 2.1(1.5) days for severity and 1.9 (1.6) days for frequency. The time to significant response maintained was 29.7 (13.8) for severity and 29.0 (14.3) for frequency.
次要结局
- Use of Acute and Rescue Medications During Loading (2 Days) and Maintenance Phases as Compared to Subject-reported Baseline. This Will be Calculated Using the Total Number of Doses of Acute Medications Per 24-hour Period Calendar Days.(Baseline compared to maintenance (up to 47 days))
- Change in Frequency of Attacks Per 24 Hour Period, Duration of Individual Attacks (in Minutes), or Severity of Attacks Compared to the Subject-reported Baseline Values.(Compare Baseline through 47 days)