Trial Outcomes & Findings for Greater Occipital Nerve Block for Migraine Prophylaxis (NCT NCT00915473)
NCT ID: NCT00915473
Last Updated: 2014-03-20
Results Overview
The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
4 weeks pre-injection baseline, 4 weeks post-injection
Results posted on
2014-03-20
Participant Flow
Subjects were recruited by referral from multiple neurologists in the division of Headache at Mayo Clinic in Arizona from June 2009 to October 2012.
Participant milestones
| Measure |
Active Injection
Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
Placebo Injection
Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
|---|---|---|
|
Screening
STARTED
|
35
|
35
|
|
Screening
COMPLETED
|
34
|
35
|
|
Screening
NOT COMPLETED
|
1
|
0
|
|
Injection
STARTED
|
34
|
35
|
|
Injection
COMPLETED
|
34
|
35
|
|
Injection
NOT COMPLETED
|
0
|
0
|
|
4-week Follow Up
STARTED
|
34
|
35
|
|
4-week Follow Up
COMPLETED
|
33
|
30
|
|
4-week Follow Up
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Active Injection
Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
Placebo Injection
Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
|---|---|---|
|
Screening
Withdrawal by Subject
|
1
|
0
|
|
4-week Follow Up
Lost to Follow-up
|
1
|
5
|
Baseline Characteristics
Greater Occipital Nerve Block for Migraine Prophylaxis
Baseline characteristics by cohort
| Measure |
Active Injection
n=35 Participants
Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
Placebo Injection
n=35 Participants
Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 11 • n=5 Participants
|
43 years
STANDARD_DEVIATION 15 • n=7 Participants
|
43 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks pre-injection baseline, 4 weeks post-injectionPopulation: Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.
The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection.
Outcome measures
| Measure |
Active Injection
n=33 Participants
Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
Placebo Injection
n=30 Participants
Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
|---|---|---|
|
Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period
|
10 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 4 weeks post-injectionPopulation: Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.
Outcome measures
| Measure |
Active Injection
n=33 Participants
Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
Placebo Injection
n=30 Participants
Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
|---|---|---|
|
Mean Frequency of Days With a Migraine
Severe
|
3.4 days per 4 weeks
Standard Deviation 3.4
|
2.9 days per 4 weeks
Standard Deviation 2.7
|
|
Mean Frequency of Days With a Migraine
At Least Moderate
|
7.0 days per 4 weeks
Standard Deviation 4.2
|
7.8 days per 4 weeks
Standard Deviation 5.8
|
|
Mean Frequency of Days With a Migraine
At Least Mild
|
9.3 days per 4 weeks
Standard Deviation 4.8
|
10.4 days per 4 weeks
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: 4 weeks post-injectionPopulation: Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.
Outcome measures
| Measure |
Active Injection
n=33 Participants
Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
Placebo Injection
n=30 Participants
Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
|---|---|---|
|
Mean Number of Hours With Moderate or Severe Migraine
|
60 hours per 4 weeks
Standard Deviation 72
|
58 hours per 4 weeks
Standard Deviation 60
|
SECONDARY outcome
Timeframe: 4 weeks post-injectionPopulation: Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.
Acute medication use meant "the consumption of a drug to abort or terminate a headache."
Outcome measures
| Measure |
Active Injection
n=33 Participants
Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
Placebo Injection
n=30 Participants
Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
|
|---|---|---|
|
Mean Number of Days With Acute Medication Use
|
6.7 days per 4 weeks
Standard Deviation 4.2
|
7.7 days per 4 weeks
Standard Deviation 6.3
|
Adverse Events
Active Injection
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Injection
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Injection
n=34 participants at risk
Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the greater occipital nerve.
|
Placebo Injection
n=35 participants at risk
Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the greater occipital nerve.
|
|---|---|---|
|
Nervous system disorders
Benign Intracranial Hypertension (pseudotumor cerebri)
|
0.00%
0/34 • Participants were followed for adverse events for 4 weeks.
|
2.9%
1/35 • Number of events 1 • Participants were followed for adverse events for 4 weeks.
|
Other adverse events
| Measure |
Active Injection
n=34 participants at risk
Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the greater occipital nerve.
|
Placebo Injection
n=35 participants at risk
Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the greater occipital nerve.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection Site Pain (Onset < or = 1 day)
|
11.8%
4/34 • Number of events 4 • Participants were followed for adverse events for 4 weeks.
|
5.7%
2/35 • Number of events 2 • Participants were followed for adverse events for 4 weeks.
|
|
Gastrointestinal disorders
Abdominal Distension (Bloating, onset <1 day)
|
2.9%
1/34 • Number of events 1 • Participants were followed for adverse events for 4 weeks.
|
0.00%
0/35 • Participants were followed for adverse events for 4 weeks.
|
|
General disorders
Fat Redistribution (onset 22 days)
|
2.9%
1/34 • Number of events 1 • Participants were followed for adverse events for 4 weeks.
|
0.00%
0/35 • Participants were followed for adverse events for 4 weeks.
|
|
Skin and subcutaneous tissue disorders
Injection Site Paraesthesia (onset 14 days)
|
2.9%
1/34 • Number of events 1 • Participants were followed for adverse events for 4 weeks.
|
0.00%
0/35 • Participants were followed for adverse events for 4 weeks.
|
|
Nervous system disorders
Neuralgia (Occipital nerve tenderness, onset 61 days)
|
2.9%
1/34 • Number of events 1 • Participants were followed for adverse events for 4 weeks.
|
0.00%
0/35 • Participants were followed for adverse events for 4 weeks.
|
|
General disorders
Weight Increased (onset < 1 day)
|
2.9%
1/34 • Number of events 1 • Participants were followed for adverse events for 4 weeks.
|
0.00%
0/35 • Participants were followed for adverse events for 4 weeks.
|
|
General disorders
Fatigue (onset 1 day)
|
0.00%
0/34 • Participants were followed for adverse events for 4 weeks.
|
2.9%
1/35 • Number of events 1 • Participants were followed for adverse events for 4 weeks.
|
|
Skin and subcutaneous tissue disorders
Hypoesthesia (numbness) (onset <1 day)
|
0.00%
0/34 • Participants were followed for adverse events for 4 weeks.
|
2.9%
1/35 • Number of events 1 • Participants were followed for adverse events for 4 weeks.
|
|
Blood and lymphatic system disorders
Lymphadenopathy (swelling axilla, onset 1 day)
|
0.00%
0/34 • Participants were followed for adverse events for 4 weeks.
|
2.9%
1/35 • Number of events 1 • Participants were followed for adverse events for 4 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Upper extremity muscle soreness, onset 1 day)
|
0.00%
0/34 • Participants were followed for adverse events for 4 weeks.
|
2.9%
1/35 • Number of events 1 • Participants were followed for adverse events for 4 weeks.
|
|
Gastrointestinal disorders
Nausea (onset 32 days)
|
0.00%
0/34 • Participants were followed for adverse events for 4 weeks.
|
2.9%
1/35 • Number of events 1 • Participants were followed for adverse events for 4 weeks.
|
|
General disorders
Pain (Unspecified, onset 2 days)
|
0.00%
0/34 • Participants were followed for adverse events for 4 weeks.
|
2.9%
1/35 • Number of events 1 • Participants were followed for adverse events for 4 weeks.
|
|
Skin and subcutaneous tissue disorders
Pain of Skin (Scalp tenderness, onset < 1 day)
|
0.00%
0/34 • Participants were followed for adverse events for 4 weeks.
|
2.9%
1/35 • Number of events 1 • Participants were followed for adverse events for 4 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place