Cognitive Effects of Immediate Release Topiramate vs Extended Release Topiramate in Patients With Migraine
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Controlled Oral Word Association Test (COWA)-generative phonemic fluency
研究概览
简要总结
Crossover, randomized, double blind: Q12h dosing in both periods; matching placebo for evening dosing during XR treatment; target dose: 100mg
详细描述
The primary objective is to compare the effect of treatment with an immediate-release topiramate (IR-TPM), namely Topamax®, to an extended-release topiramate (XR-TPM), namely Trokendi XR®, regimen on cognition in adults with migraine.
The secondary objective is to determine the factors that explain inter-individual variability in cognitive response. Pharmacokinetic and demographic factors will be explored. Variability in cognitive response between individuals can be large. A population approach (nonlinear, mixed effects) will be used to determine drug exposure response relationships.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Established history of episodic migraine with or without aura, as assessed by International Headache Society criteria, for at least 6 months before screening and frequency of 3 or more headache attacks per month during the past 3 months
- •Male or female, ages 18-65
- •Women are required to be postmenopausal, surgically incapable of bearing children, or practicing a medically acceptable method of birth control (i.e., double barrier method, IUD, Mirena, etc) for at least 1 month before study entry through 30 days following last dose.
- •If postmenopausal and on hormone replacement therapy (HRT) then must to be on a stable regimen for at least 2 months (continuous stable regimen of cyclic or non-cyclic HRT); negative pregnancy test.
- •Native English speakers (due to speech and language analysis)
- •Montreal Cognitive Assessment (MoCA) score equal to or greater than 26.
排除标准
- •Onset of migraine occurred after age 50 years, or overuse of analgesics or migraine specific agents for the acute treatment of migraine episodes; examples of analgesic overuse included the following: more than 8 treatment episodes (episode defined as any calendar day of usage) of ergot containing medications a month; more than 8 treatment episodes of triptans a month; or more than 6 treatment episodes of potent opioids a month.
- •Required, continued use of the following medications for any medical reason during the study: beta-blockers, benzodiazepines, tricyclic antidepressants, antiepileptics, calcium channel blockers, monoamine oxidase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs) daily, opioids, agents for insomnia (e.g., Ambien, diphenhydramine-containing OTC products); corticosteroids, local anesthetics, botulinum toxin within last three months, or herbal preparations such as feverfew or St John's wort. However, subjects will be permitted to be on a stable regimen of a selective serotonin reuptake inhibitor or SNRI for 3 months or more for depression and/or anxiety.
- •A history of nephrolithiasis
- •Have previously taken topiramate
- •Received an experimental drug or used an experimental or approved device for migraine prevention (e.g., TENIS unit) within 30 days of screening
研究组 & 干预措施
IR-TPM (Topamax)
IR-TPM (Topamax)
干预措施: IR-TPM (Topamax) (Drug)
IR-TPM (Topamax)
IR-TPM (Topamax)
干预措施: XR-TPM (Trokendi XR) (Drug)
XR-TPM (Trokendi XR)
干预措施: IR-TPM (Topamax) (Drug)
XR-TPM (Trokendi XR)
干预措施: XR-TPM (Trokendi XR) (Drug)
结局指标
主要结局
Controlled Oral Word Association Test (COWA)-generative phonemic fluency
时间窗: Baseline (Day 1) through Day 52
The primary outcome measure is the Controlled Oral Word Association (COWA: phonemic generative fluency). COWA was chosen as the primary endpoint since in previous studies of drug-induced cognitive impairment, this measure was sensitive to the effects of topiramate (Meador et al, 2003; Marino et al, 2012; Marino et al, 2015). The primary endpoint is a change in the COWA score from baseline to each post-dose assessment
次要结局
- Digit Span Backward(Baseline (Day 1) through Day 52)
- Measures of semantic verbal fluency(Baseline (Day 1) through Day 52)
- Digit Symbol Modalities Test (SDMT)(Baseline (Day 1) through Day 52)
- Trails A & B(Baseline (Day 1) through Day 52)