Trial Outcomes & Findings for Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine (NCT NCT03712917)
NCT ID: NCT03712917
Last Updated: 2020-01-21
Results Overview
Range Pain 0-10, 0: No pain, 10: Worst Pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Post treatment 4 weeks
Results posted on
2020-01-21
Participant Flow
Participant milestones
| Measure |
Greater Occipital Nerve Block
The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼" (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.
Greater Occipital Nerve Block: An enjection to paralyze the occipital nerve.
|
Topiramate
Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.
Topiramate: An antiepileptic agent used for migraine prophylaxis.
|
Flunarizine
Flunarizine is introduced with a single dose of 10 mg/day.
Flunarizine: A calcium overload blocker agent used for migraine prophylaxis.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
31
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
9
|
Reasons for withdrawal
| Measure |
Greater Occipital Nerve Block
The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼" (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.
Greater Occipital Nerve Block: An enjection to paralyze the occipital nerve.
|
Topiramate
Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.
Topiramate: An antiepileptic agent used for migraine prophylaxis.
|
Flunarizine
Flunarizine is introduced with a single dose of 10 mg/day.
Flunarizine: A calcium overload blocker agent used for migraine prophylaxis.
|
|---|---|---|---|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
9
|
4
|
5
|
Baseline Characteristics
Row population is the defined after the exclusion of patients from overall study population
Baseline characteristics by cohort
| Measure |
Greater Occipital Nerve Block
n=40 Participants
The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼" (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.
Greater Occipital Nerve Block: An enjection to paralyze the occipital nerve.
|
Topiramate
n=40 Participants
Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.
Topiramate: An antiepileptic agent used for migraine prophylaxis.
|
Flunarizine
n=40 Participants
Flunarizine is introduced with a single dose of 10 mg/day.
Flunarizine: A calcium overload blocker agent used for migraine prophylaxis.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30.2 years
STANDARD_DEVIATION 8.9 • n=31 Participants • Row population is the defined after the exclusion of patients from overall study population
|
31.5 years
STANDARD_DEVIATION 8.2 • n=32 Participants • Row population is the defined after the exclusion of patients from overall study population
|
30.9 years
STANDARD_DEVIATION 9.0 • n=31 Participants • Row population is the defined after the exclusion of patients from overall study population
|
30.9 years
STANDARD_DEVIATION 8.6 • n=94 Participants • Row population is the defined after the exclusion of patients from overall study population
|
|
Sex: Female, Male
Female
|
22 Participants
n=31 Participants • Row population is the defined after the exclusion of patients from overall study population
|
26 Participants
n=32 Participants • Row population is the defined after the exclusion of patients from overall study population
|
24 Participants
n=31 Participants • Row population is the defined after the exclusion of patients from overall study population
|
72 Participants
n=94 Participants • Row population is the defined after the exclusion of patients from overall study population
|
|
Sex: Female, Male
Male
|
9 Participants
n=31 Participants • Row population is the defined after the exclusion of patients from overall study population
|
6 Participants
n=32 Participants • Row population is the defined after the exclusion of patients from overall study population
|
7 Participants
n=31 Participants • Row population is the defined after the exclusion of patients from overall study population
|
22 Participants
n=94 Participants • Row population is the defined after the exclusion of patients from overall study population
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=40 Participants
|
40 Participants
n=40 Participants
|
40 Participants
n=40 Participants
|
120 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: Post treatment 4 weeksRange Pain 0-10, 0: No pain, 10: Worst Pain
Outcome measures
| Measure |
Greater Occipital Nerve Block
n=31 Participants
The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼" (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.
Greater Occipital Nerve Block: An enjection to paralyze the occipital nerve.
|
Topiramate
n=32 Participants
Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.
Topiramate: An antiepileptic agent used for migraine prophylaxis.
|
Flunarizine
n=31 Participants
Flunarizine is introduced with a single dose of 10 mg/day.
Flunarizine: A calcium overload blocker agent used for migraine prophylaxis.
|
|---|---|---|---|
|
Visual Analog Scale
Pretreatment
|
8.1 score on a scale
Standard Deviation 1.0
|
7.9 score on a scale
Standard Deviation 0.9
|
7.9 score on a scale
Standard Deviation 0.9
|
|
Visual Analog Scale
Posttreatment
|
5.9 score on a scale
Standard Deviation 1.6
|
5.5 score on a scale
Standard Deviation 2.1
|
5.3 score on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Post treatment 4 weeksNumber of headaches patients suffer in a month.
Outcome measures
| Measure |
Greater Occipital Nerve Block
n=31 Participants
The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼" (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.
Greater Occipital Nerve Block: An enjection to paralyze the occipital nerve.
|
Topiramate
n=32 Participants
Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.
Topiramate: An antiepileptic agent used for migraine prophylaxis.
|
Flunarizine
n=31 Participants
Flunarizine is introduced with a single dose of 10 mg/day.
Flunarizine: A calcium overload blocker agent used for migraine prophylaxis.
|
|---|---|---|---|
|
Attack Frequencies
Pretreatment
|
8.6 headaches per month
Standard Deviation 2.6
|
8.0 headaches per month
Standard Deviation 2.7
|
8.0 headaches per month
Standard Deviation 2.4
|
|
Attack Frequencies
Posttreatment
|
3.3 headaches per month
Standard Deviation 1.0
|
2.7 headaches per month
Standard Deviation 2.3
|
2.8 headaches per month
Standard Deviation 1.4
|
Adverse Events
Flunarizine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Greater Occipital Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Topiramate
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flunarizine
n=40 participants at risk
Flunarizine is introduced with a single dose of 10 mg/day.
Flunarizine: A calcium overload blocker agent used for migraine prophylaxis.
|
Greater Occipital Nerve Block
n=40 participants at risk
The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼" (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.
Greater Occipital Nerve Block: An enjection to paralyze the occipital nerve.
|
Topiramate
n=40 participants at risk
Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.
Topiramate: An antiepileptic agent used for migraine prophylaxis.
|
|---|---|---|---|
|
Nervous system disorders
Sedation
|
7.5%
3/40 • Number of events 3 • From the start of the study till the end (one month)
|
0.00%
0/40 • From the start of the study till the end (one month)
|
0.00%
0/40 • From the start of the study till the end (one month)
|
|
Nervous system disorders
Fatique
|
0.00%
0/40 • From the start of the study till the end (one month)
|
0.00%
0/40 • From the start of the study till the end (one month)
|
2.5%
1/40 • Number of events 1 • From the start of the study till the end (one month)
|
|
Nervous system disorders
paresthesia
|
0.00%
0/40 • From the start of the study till the end (one month)
|
0.00%
0/40 • From the start of the study till the end (one month)
|
2.5%
1/40 • Number of events 1 • From the start of the study till the end (one month)
|
|
Nervous system disorders
memory difficulties
|
0.00%
0/40 • From the start of the study till the end (one month)
|
0.00%
0/40 • From the start of the study till the end (one month)
|
5.0%
2/40 • Number of events 2 • From the start of the study till the end (one month)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place