Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine (Tx360)
|ClinicalTrials.gov Identifier: NCT01709708|
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : October 20, 2014
Last Update Posted : January 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Migraine||Drug: Marcaine Drug: Saline||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Use of the Tx360 Nasal Applicator for Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine: A Double-blind Placebo-controlled Study|
|Study Start Date :||September 2012|
|Primary Completion Date :||February 2014|
|Study Completion Date :||February 2014|
Active Comparator: 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)
Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
Other Name: Bupivicane (generic)
Placebo Comparator: Saline
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
- Numeric Rating Scale (NRS) [ Time Frame: 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.
- Change in Numeric Rating Scale (NRS) [ Time Frame: 15 Minutes Post Treatment, 30 minutes Post Treatment and 24 hours Post Treatment, assessed up to 6 weeks ]Compare percentage change in Numeric Rating Scale (NRS) score from Before Procedure to 15-Minutes, Before Procedure to 30-Minutes, Before Procedure to 24-Hours After Procedure for all 12 treatments (Mean of all 12 treatments for each timepoint, comparing Group A to Group B). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain.
- Patient's Global Impression of Change (PGIC) [ Time Frame: 30 minutes Post Treatment and 24 hours Post Treatment, assessed up to 6 weeks ]Compare 24-Hour After Procedure Patient's Global Impression of Change (PGIC) score for 12 treatments (Mean of all 12 treatments for each timepoint, comparing Group A to Group B). PGIC is a likert scale ranging from 1 to 7 with 1 being very much improved and 7 being very much worse.
- Modified Pain Characteristic Questionnaire [ Time Frame: Before Treatment, 24 Hours After Treatment, 1 Month Post Treatment, and 6 Months Post Treatment ]Compare Modified Pain Characteristic Questionnaire scores Before Procedure vs. 24-Hour After Procedure, Before Procedure vs. 1-Month Follow Up, and Before Procedure vs. 6-Month Follow Up (Mean of all 12 treatments for each timepoint, comparing Group A to Group B). The modified pain characteristic questionnaire is a series of 11 questions on a likert scale ranging from 0 to 10 with 0 being no pain or does not interfere and 10 being worst pain or completely interferes. Percentage questions range from 0 to 100.
- Migraine Headache Days [ Time Frame: 12 Weeks ]Compare change in the number of migraine headache days per month reported in Baseline Period Diary vs. Treatment Period Diary vs. Post-Treatment Period Diary.
- Acute Medications Usage [ Time Frame: 10 Weeks ]Number of acute medications used during Treatment period (6 weeks) and Follow-Up (4 weeks) (Group A vs. Group B).
- Adverse Events [ Time Frame: 34 weeks ]Number of adverse events over the entire length of study (Group A vs. Group B).
- Headache Impact Test (HIT-6) [ Time Frame: 10 Weeks ]Total Headache Impact Test (HIT-6) scores Pre-Treatment at Visit 2 vs. Post-Treatment (following final treatment), and at 1-Month Post-Treatment (Group A vs. Group B). HIT-6 is a series of 6 likert scale questions ranging from 1 to 5 with 1 being never and 5 being always. The HIT-6 answer options are weighted as follows: Never (1) = 6 points each, Rarely (2) = 9 points each, Sometimes (3) = 10 points each, Very often (4) = 11 points each, Always (5) = 13 points each. The total score for the HIT-6 ranges from 36 (subject answers all 6 questions as "Never") to 78 subject answers all 6 questions as "Always"), with higher total scores indicating more impact than lower scores, i.e., headaches cause greater impact on the subject's life.
- Overall Satisfaction [ Time Frame: 10 Weeks ]Satisfaction scores Visit 2 vs. following treatment (Treatment 12) and at 1-Month Post-Treatment (Group A vs. Group B). Satisfaction scores are a likert scale ranging from 1 to 5 with 1 being complete dissatisfaction and 5 being complete satisfaction.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709708
|United States, Michigan|
|Michigan Head Pain & Neurological Institute|
|Ann Arbor, Michigan, United States, 48104|
|United States, Missouri|
|Clinvest/A Division of Banyan Group, Inc.|
|Springfield, Missouri, United States, 65807|
|Principal Investigator:||Tian Xia, MD||Tian Medical Inc.|