Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine
| Status: | Completed |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 1/28/2018 |
| Start Date: | September 2012 |
| End Date: | February 2014 |
Use of the Tx360 Nasal Applicator for Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine: A Double-blind Placebo-controlled Study
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.
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.
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.
At each treatment visit (Visits 2-13), in addition to Before Procedure questions, subjects
will complete 15-minute and 30-minute After Procedure questionnaires to include the NRS and,
at 30 minutes, the Patient's Global Impression of Change (PGIC). Subjects will take home a
questionnaire to include the NRS, PGIC, satisfaction question, and the Modified Pain
Characteristic Questionnaire to be completed at 24 hours following treatment and be
instructed to return the 24-hour After Procedure questionnaire to the clinic at the next
visit.
At Visits 2-15 vital signs will be completed, medications will be updated, and Non-Serious
Adverse Events will be collected after the first treatment. Serious Adverse Events will be
collected once the informed consent has been signed and throughout the study.
At Visits 5, 8, and 11, the Treatment Period Headache Diary will be collected, reviewed, and
re-dispensed.
At Visit 13, the 1-Month Post-Treatment Period Diary will be dispensed.
The subject will return to the clinic at Visit 14 between 24 and 96 hours following the final
treatment at Visit 13 to return the 24-hour After Procedure Questionnaire and complete the
1-Month Treatment Period HIT-6. The Treatment Period Diary will be collected.
At Visit 15, 1 month following the final treatment, each subject will return to the clinic
and complete a 1-Month Follow Up HIT-6 and the 1-Month Follow Up Questionnaire. The 1-Month
Post-Treatment Period Diary will be collected.
At 6 months following the final treatment, each subject will be phoned to complete the
6-Month Follow Up Questionnaire to include the NRS, PGIC, satisfaction question, the Modified
Pain Characteristic Questionnaire, and a 6-Month Follow Up HIT-6.
Treatment Medication Subjects randomized to Group A will be administered 0.3 mL of 0.5%
Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the SPG.
Twelve treatments will be administered over a period of 6 weeks.
Subjects randomized to Group B will be administered saline substituted for Marcaine delivered
bilaterally with the Tx360TM device to the mucosa associated with the SPG for treatment of
chronic migraine. Twelve treatments will be administered over a period of 6 weeks.
Rescue Medication Subjects will be allowed to rescue with medication mutually agreed upon by
subject and Investigator at the time of screening.
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.
At each treatment visit (Visits 2-13), in addition to Before Procedure questions, subjects
will complete 15-minute and 30-minute After Procedure questionnaires to include the NRS and,
at 30 minutes, the Patient's Global Impression of Change (PGIC). Subjects will take home a
questionnaire to include the NRS, PGIC, satisfaction question, and the Modified Pain
Characteristic Questionnaire to be completed at 24 hours following treatment and be
instructed to return the 24-hour After Procedure questionnaire to the clinic at the next
visit.
At Visits 2-15 vital signs will be completed, medications will be updated, and Non-Serious
Adverse Events will be collected after the first treatment. Serious Adverse Events will be
collected once the informed consent has been signed and throughout the study.
At Visits 5, 8, and 11, the Treatment Period Headache Diary will be collected, reviewed, and
re-dispensed.
At Visit 13, the 1-Month Post-Treatment Period Diary will be dispensed.
The subject will return to the clinic at Visit 14 between 24 and 96 hours following the final
treatment at Visit 13 to return the 24-hour After Procedure Questionnaire and complete the
1-Month Treatment Period HIT-6. The Treatment Period Diary will be collected.
At Visit 15, 1 month following the final treatment, each subject will return to the clinic
and complete a 1-Month Follow Up HIT-6 and the 1-Month Follow Up Questionnaire. The 1-Month
Post-Treatment Period Diary will be collected.
At 6 months following the final treatment, each subject will be phoned to complete the
6-Month Follow Up Questionnaire to include the NRS, PGIC, satisfaction question, the Modified
Pain Characteristic Questionnaire, and a 6-Month Follow Up HIT-6.
Treatment Medication Subjects randomized to Group A will be administered 0.3 mL of 0.5%
Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the SPG.
Twelve treatments will be administered over a period of 6 weeks.
Subjects randomized to Group B will be administered saline substituted for Marcaine delivered
bilaterally with the Tx360TM device to the mucosa associated with the SPG for treatment of
chronic migraine. Twelve treatments will be administered over a period of 6 weeks.
Rescue Medication Subjects will be allowed to rescue with medication mutually agreed upon by
subject and Investigator at the time of screening.
Inclusion Criteria:
1. Is male or female, in otherwise good health, 18 to 80 years of age.
2. 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.
3. Has onset of migraine before age 50.
4. Is able to differentiate migraine from any other headache they may experience (e.g.,
tension-type headache).
5. 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.
6. 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.
1. 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,
2. Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of
pregnancy); or,
3. Sterilization of male partner; or,
4. Intrauterine device with published data showing lowest expected failure rate is
less than 1% per year; or,
5. 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,
6. Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout
study.
7. Has pain presentation in frontal, temporal, ophthalmic, maxillary, mandibular, facial,
or intraoral location.
Exclusion Criteria:
1. Is male or female, in otherwise good health, 18 to 80 years of age.
2. 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.
3. Has onset of migraine before age 50.
4. Is able to differentiate migraine from any other headache they may experience (e.g.,
tension-type headache).
5. 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.
6. 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.
1. 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,
2. Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of
pregnancy); or,
3. Sterilization of male partner; or,
4. Intrauterine device with published data showing lowest expected failure rate is
less than 1% per year; or,
5. 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,
6. Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout
study.
7. Has pain presentation in frontal, temporal, ophthalmic, maxillary, mandibular, facial,
or intraoral location.
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