Trial Outcomes & Findings for Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines (NCT NCT02090998)
NCT ID: NCT02090998
Last Updated: 2024-07-16
Results Overview
The number of times per day that symptoms occur
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
Study Day 1 through Study Day 30
Results posted on
2024-07-16
Participant Flow
Participant milestones
| Measure |
Amitriptyline / Elavil
Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated
SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia
Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
|
SPG Nerve Block With Lidocaine 5% Gel
Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated
SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia
Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
8
|
|
Overall Study
COMPLETED
|
2
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines
Baseline characteristics by cohort
| Measure |
Amitriptyline / Elavil
n=2 Participants
Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated
SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia
Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
|
SPG Nerve Block With Lidocaine 5% Gel
n=8 Participants
Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated
SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia
Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46 years
n=5 Participants
|
59 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Day 1 through Study Day 30Population: participants from 18-82 who had failed conventional headache therapies
The number of times per day that symptoms occur
Outcome measures
| Measure |
Amitriptyline / Elavil
n=2 Participants
Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia
Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
|
SPG Nerve Block With Lidocaine 5% Gel
n=8 Participants
Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated
SPG Block with 5% Lidocaine gel: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia
Amitriptyline: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
|
|---|---|---|
|
Number of Daily Headaches
|
20.5 Number of Daily Headaches
Standard Deviation 0.5
|
13.4 Number of Daily Headaches
Standard Deviation 10.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Study Day 1 thorugh Study Day 30The time after events that effects patient activity level
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Greater than 20 minutesLength of Duration of Headache
Outcome measures
Outcome data not reported
Adverse Events
Amitriptyline / Elavil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SPG Nerve Block With Lidocaine 5% Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place