Use of the Tx360 Nasal Applicator for Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine: A Double-blind Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale (NRS)
研究概览
简要总结
Migraine imposes a substantial burden on patients in terms of diminished daily functioning, quality of life, and financial loss. Pain severity and duration correlates with reduced measures of daily functioning, and overall health status. The sphenopalatine ganglion (SPG) has been implicated in a variety of cephalalgias. This has been well represented in the literature dating back over a century. Access to this structure can be gained via a small area of mucosa just posterior and superior to the tail of the middle turbinate on the lateral nasal wall. At this aspect, there is no bony boundary to the SPG. Blocking the SPG using local anesthetics relieves pain. Unfortunately, many current interventions are cumbersome, invasive, and expensive. The purpose of this study is to evaluate the efficacy of the Tx360™, a new nasal applicator device, in the treatment of head and face pain and to examine the economic implications. The Tx360™ is a single use device designed to deliver a topical local anesthetic to the specific area of mucosa associated with the SPG. A total of 42 study participants will be accepted into this double-blind placebo-controlled study. 28 will receive SPG blocks using a 0.3 mL of a 0.5% solution of Marcaine delivered by the Tx360™ while 14 will receive a placebo of saline substituted for the Marcaine. Both patient sets will also be given a piece of lemon hard candy as a taste distractor. Participants must have a chronic migraine history with over 15 symptomatic days per month over the past three months. The treatment plan consists of six weeks of treatment, two times per week. Short and longer term assessments will be retrieved and analyzed as detailed in the Study Design.
详细描述
42 study participants will be included in this double-blind placebo-controlled study. Following enrollment of 42 subjects and completion of the 6-week Treatment Period by all active subjects, an analysis of the treatment effect will be performed for a reassessment of sample size and, if deemed appropriate, the study will continue with enrollment of additional subjects to ensure a more statistically robust interpretation of the data. The results of the statistical analysis will be blinded from Investigators and coordinators. The procedure will be delivered to all subjects who agree to participate, meet inclusion criteria, and sign informed consent.
At Visit 1 following Informed Consent, a physical exam and vital signs will be completed. A medical, headache, and medication history (to include age, sex, height and weight, and duration and location of headache pain, as well as history of ER visits) will be collected on all subjects. Eligible subjects will be provided with a Baseline Headache Diary and instructed to treat migraines for the following month in their usual manner with their usual treatment. The daily Diary will document headache, acute treatment and response, and migraine associated symptoms (nausea, vomiting, light sensitivity, or sound sensitivity) to establish a Baseline number of headache days and severity. Visit 2 will be scheduled for 1 month following Visit 1. Following Visit 1, Visits 2-13 (treatment visits) will be scheduled to occur twice weekly (during the regular Monday - Friday work week) at least 2 days apart. Treatments should not occur on consecutive days.
At Visit 2, the Baseline Headache Diary will be reviewed and those subjects continuing to meet eligibility will be dispensed a 6-week Treatment Period Diary and complete Before Procedure questions to include the Pain Intensity Numeric Rating Scale (NRS), the Modified Pain Characteristic Questionnaire, and a baseline Headache Impact Test-6 (HIT-6), have vital signs completed, and the medical, headache, and medication history updated. Subjects will be randomized 2:1 to Group A or Group B. Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the SPG. Group B will receive saline substituted for Marcaine delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
To maintain the blinding of the treatment groups, neither the Investigator nor research personnel who are involved in evaluating the subject should prepare the study medication. An independent research staff person with no involvement in the study conduct will place study medication (either Marcaine for a subject randomized to Group A or Placebo/saline for a subject randomized to Group B) in a 1cc Luer Lok tip syringe and assemble the syringe and Tx360TM catheter as instructed in training. A label with the subject Drug Number will be placed on the device at that time. The research staff person administering the study medication will verify that the Drug Number assignment is correct.
Both Groups will be given a piece of lemon hard candy as a taste distractor.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is male or female, in otherwise good health, 18 to 80 years of age.
- •Has history of chronic migraine (with or without aura) according to the criteria proposed by the Headache Classification Committee of the International Headache Society for at least 3 months prior to enrollment.
- •Has onset of migraine before age
- •Is able to differentiate migraine from any other headache they may experience (e.g., tension-type headache).
- •Is not currently taking a migraine preventive or has been taking preventive for at least 30 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period.
- •If female of childbearing potential, agrees to use, for the duration of the study, a medically acceptable form of contraception as determined by the Investigator.
- •Complete abstinence from intercourse from 2 weeks prior to administration of study drug throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the study drug; or,
- •Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); or,
- •Sterilization of male partner; or,
- •Intrauterine device with published data showing lowest expected failure rate is less than 1% per year; or,
- •Double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus spermicide) for a least 1 month prior to Visit 1 and throughout study; or,
- •Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study.
- •Has pain presentation in frontal, temporal, ophthalmic, maxillary, mandibular, facial, or intraoral location.
排除标准
- •Is male or female, in otherwise good health, 18 to 80 years of age.
- •Has history of chronic migraine (with or without aura) according to the criteria proposed by the Headache Classification Committee of the International Headache Society for at least 3 months prior to enrollment.
- •Has onset of migraine before age
- •Is able to differentiate migraine from any other headache they may experience (e.g., tension-type headache).
- •Is not currently taking a migraine preventive or has been taking preventive for at least 30 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period.
- •If female of childbearing potential, agrees to use, for the duration of the study, a medically acceptable form of contraception as determined by the Investigator.
- •Complete abstinence from intercourse from 2 weeks prior to administration of study drug throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the study drug; or,
- •Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); or,
- •Sterilization of male partner; or,
- •Intrauterine device with published data showing lowest expected failure rate is less than 1% per year; or,
- •Double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus spermicide) for a least 1 month prior to Visit 1 and throughout study; or,
- •Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study.
- •Has pain presentation in frontal, temporal, ophthalmic, maxillary, mandibular, facial, or intraoral location.
研究组 & 干预措施
Marcaine
Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
干预措施: Marcaine (Drug)
Saline
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
干预措施: Saline (Drug)
结局指标
主要结局
Numeric Rating Scale (NRS)
时间窗: 6 Weeks
Compare Numeric Rating Scale (NRS) scores Before Procedure,15-Minute Post Treatment, 30-Minutes Post Treatment, 24-Hour Post Treatment for all 12 treatments (Marcaine vs. Saline). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain. For each individual time point, all 12 treatments were averaged for that time point and a single value was used for comparison between the two groups.
次要结局
- Adverse Events(34 weeks)
- Change in Numeric Rating Scale (NRS)(15 Minutes Post Treatment, 30 minutes Post Treatment and 24 hours Post Treatment, assessed up to 6 weeks)
- Modified Pain Characteristic Questionnaire(Before Treatment, 24 Hours After Treatment, 1 Month Post Treatment, and 6 Months Post Treatment)
- Migraine Headache Days(12 Weeks)
- Patient's Global Impression of Change (PGIC)(30 minutes Post Treatment and 24 hours Post Treatment, assessed up to 6 weeks)
- Acute Medications Usage(10 Weeks)
- Headache Impact Test (HIT-6)(10 Weeks)
- Overall Satisfaction(10 Weeks)