Follow-the-Suture vs PREEMPT: A Comparative Study of OnabotulinumtoxinA Injection Methods for Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
研究概览
简要总结
OnabotulinumtoxinA is currently one of the therapies specifically approved for the prevention of chronic migraine. Its efficacy was firmly established in the pivotal Phase III PREEMPT (Phase 3 Research Evaluating Migraine Prophylaxis Therapy) trials, which demonstrated significant reductions in headache frequency and disability, alongside improvements in quality of life compared with placebo. There is a paucity of data comparing alternative techniques like Follow-the-suture method with PREEMPT protocol for administration of OnabotulinumtoxinA in patients with chronic migraine. Recent anatomical and experimental insights suggest that cranial sutures represent critical sites for nociceptive innervation, as meningeal collaterals traverse the skull through these junctions. Based on this rationale, an alternative injection approach termed the Follow-the-Sutures method has been proposed, wherein it is administered along cranial suture lines rather than muscle groups. This strategy may offer similar or improved efficacy. Herein we aim to compare, Follow-the-suture technique for administering OnabotulinumtoxinA to the PREEMPT method in patients of Chronic Migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Fulfilling diagnostic criteria for chronic migraine as per ICHD-
- •Patients who have been on at least one preventive medication for a minimum duration of 3 months, with no dose changes in the preceding month.
- •Patients willing to provide informed written consent.
排除标准
- •Prior neurological diseases such as brain tumors, dementia, seizures, encephalitis, meningitis, or stroke.
- •Patients failing to complete the headache diary for more than six non-consecutive days during the 28-day baseline period.
- •Patients unable to maintain a headache diary due to illiteracy or lack of caregiver support.
- •Patients with contraindications to OnabotulinumtoxinA injections (e.g., prior allergy, infection at injection site, neuromuscular disorders).
- •Pregnancy or lactation.
研究者
Dr Aktar Hussain Barbhuiya
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. RML Hospital