Trial Outcomes & Findings for Sphenopalatine Nerve Block for Headache Tx360 (NCT NCT01939314)

NCT ID: NCT01939314

Last Updated: 2015-07-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 93 participants
• Primary outcome timeframe: 15 minutes from dose
• Results posted on: 2015-07-27

Participant Flow

165 Patients Identified

93 Patients Enrolled 47 Patients Excluded 25 Patients Declined

Participant milestones

Measure	Bupivacaine Bupivicaine .03ml to each nare Bupivacaine: intervention	Normal Saline normal saline .03 ml to each nare Placebo: Placebo
Overall Study STARTED	45	48
Overall Study 15 Minute Endpoint	41	46
Overall Study 24 Hour Endpoint	36	40
Overall Study COMPLETED	36	40
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Measure	Bupivacaine Bupivicaine .03ml to each nare Bupivacaine: intervention	Normal Saline normal saline .03 ml to each nare Placebo: Placebo
Overall Study Withdrawal by Subject	3	1
Overall Study Protocol Violation	1	0
Overall Study Pregnancy	0	1
Overall Study Lost to Follow-up	5	6

Baseline Characteristics

Sphenopalatine Nerve Block for Headache Tx360

Baseline characteristics by cohort

Measure	Bupivacaine n=41 Participants Bupivacaine delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally	Normal Saline n=46 Participants Normal Saline delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally	Total n=87 Participants Total of all reporting groups
Age, Continuous	33 years n=5 Participants	41 years n=7 Participants	39 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Median Baseline Headache Score	80 units on a scale n=5 Participants	79 units on a scale n=7 Participants	79 units on a scale n=5 Participants
Median Baseline Nausea Score	29 units on a scale n=5 Participants	0 units on a scale n=7 Participants	20 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes from dose

Outcome measures

Measure	Bupivacaine n=41 Participants Bupivicaine .03ml to each nare	Normal Saline n=46 Participants Normal Saline .03ml to each nare
Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale	48.8 percentage of participants	41.3 percentage of participants

SECONDARY outcome

Timeframe: 15 minutes from dose

Categorical Pain Relief at 15 minutes. Participants were asked to categorize their pain relief at 15 minutes as "No", "Little", "Some", "A Lot" or "Complete". The table displays the number of participants who identified their pain relief in the categories provided.

Outcome measures

Measure	Bupivacaine n=41 Participants Bupivicaine .03ml to each nare	Normal Saline n=46 Participants Normal Saline .03ml to each nare
Categorical Pain Relief No Pain Relief	13 participants	13 participants
Categorical Pain Relief A Little Pain Relief	6 participants	9 participants
Categorical Pain Relief Some Pain Relief	3 participants	8 participants
Categorical Pain Relief A Lot of Pain Relief	11 participants	10 participants
Categorical Pain Relief Complete Pain Relief	8 participants	6 participants

SECONDARY outcome

Timeframe: 24 hours

The percentage of patients that were headache free at 24 hours by follow-up phone conversation.

Outcome measures

Measure	Bupivacaine n=36 Participants Bupivicaine .03ml to each nare	Normal Saline n=40 Participants Normal Saline .03ml to each nare
Headache Free at 24 Hours	72.2 percentage of participants	47.5 percentage of participants

Adverse Events

Bupivacaine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bupivacaine n=41 participants at risk Bupivicaine .03ml to each nare Bupivacaine: intervention	Normal Saline n=46 participants at risk normal saline .03 ml to each nare Placebo: Placebo
General disorders Nasal Congestion	4.9% 2/41 • 24 Hours At 24 hour phone contact we assesses for any nasopharyngeal symptoms, ongoing headache or nausea, or other adverse events.	2.2% 1/46 • 24 Hours At 24 hour phone contact we assesses for any nasopharyngeal symptoms, ongoing headache or nausea, or other adverse events.
General disorders Sore Throat	2.4% 1/41 • 24 Hours At 24 hour phone contact we assesses for any nasopharyngeal symptoms, ongoing headache or nausea, or other adverse events.	0.00% 0/46 • 24 Hours At 24 hour phone contact we assesses for any nasopharyngeal symptoms, ongoing headache or nausea, or other adverse events.
Injury, poisoning and procedural complications Minor Epistaxis	0.00% 0/41 • 24 Hours At 24 hour phone contact we assesses for any nasopharyngeal symptoms, ongoing headache or nausea, or other adverse events.	4.3% 2/46 • 24 Hours At 24 hour phone contact we assesses for any nasopharyngeal symptoms, ongoing headache or nausea, or other adverse events.
General disorders Hoarseness	2.4% 1/41 • 24 Hours At 24 hour phone contact we assesses for any nasopharyngeal symptoms, ongoing headache or nausea, or other adverse events.	0.00% 0/46 • 24 Hours At 24 hour phone contact we assesses for any nasopharyngeal symptoms, ongoing headache or nausea, or other adverse events.
General disorders Nasal Dryness	2.4% 1/41 • 24 Hours At 24 hour phone contact we assesses for any nasopharyngeal symptoms, ongoing headache or nausea, or other adverse events.	0.00% 0/46 • 24 Hours At 24 hour phone contact we assesses for any nasopharyngeal symptoms, ongoing headache or nausea, or other adverse events.

Additional Information

Jason Schaffer, MD

Indiana University School of Medicine

Phone: 317-962-8026

Email: jtschaff@iupui.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place