Trial Outcomes & Findings for Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches (NCT NCT04341298)

NCT ID: NCT04341298

Last Updated: 2023-01-09

Results Overview

Change in migraine pain from baseline to 2 hours after device application, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: from baseline to 2 hours after device application
• Results posted on: 2023-01-09

Participant Flow

Participant milestones

Measure	Avulux® Device Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Avulux®: Avulux® device	Control/Sham Device Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Sham Avulux®: Sham Avulux®
Overall Study STARTED	38	40
Overall Study COMPLETED	38	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches

Baseline characteristics by cohort

Measure	Avulux® Device n=38 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Avulux®: Avulux® device	Control/Sham Device n=40 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Sham Avulux®: Sham Avulux®	Total n=78 Participants Total of all reporting groups
Age, Continuous	48.1 years STANDARD_DEVIATION 13.3 • n=5 Participants	44.3 years STANDARD_DEVIATION 13.9 • n=7 Participants	46.2 years STANDARD_DEVIATION 13.7 • 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	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized White	31 Participants n=5 Participants	34 Participants n=7 Participants	65 Participants n=5 Participants
Race/Ethnicity, Customized Black or African-American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	38 Participants n=5 Participants	40 Participants n=7 Participants	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: from baseline to 2 hours after device application

Population: The analysis population consists of the participants who experienced a minimum of one severe headache during the study and for whom pain scores were reported at baseline and 2 hours after device application for their first severe headache.

Change in migraine pain from baseline to 2 hours after device application, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.

Outcome measures

Measure	Avulux® Device n=26 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Avulux®: Avulux® device	Control/Sham Device n=29 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Sham Avulux®: Sham Avulux®
Change in 11-point Pain Scale Score After Two Hours (First Severe Headache)	-1.42 score on a scale Standard Deviation 1.90	-1.14 score on a scale Standard Deviation 1.43

SECONDARY outcome

Timeframe: from baseline to four hours after device application

Population: The analysis population consists of the participants who experienced a minimum of one severe headache during the study and for whom pain scores were reported at baseline and 4 hours after device application for their first severe headache.

Change in migraine pain from baseline to 4 hours after device application, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.

Outcome measures

Measure	Avulux® Device n=21 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Avulux®: Avulux® device	Control/Sham Device n=25 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Sham Avulux®: Sham Avulux®
Change in 11-point Pain Scale Score After Four Hours (First Severe Headache)	-2.67 score on a scale Standard Deviation 2.67	-2.80 score on a scale Standard Deviation 2.66

OTHER_PRE_SPECIFIED outcome

Timeframe: from baseline to 2 hours after device application

Population: The analysis population consists of the participants who experienced a minimum of one severe headache during the study and for whom pain scores were reported at baseline and 2 hours after device application for their first severe headache.

Number of subjects who show quantifiable improvement in overall migraine impact, as measured by a change in migraine pain from severe (i.e. baseline pain score of 6 or higher) to mild/no pain (defined as a pain score of 3 or less) after an elapsed time of 2 hours following application of the device, based on first severe or very severe migraine headache experienced by a study subject. Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.

Outcome measures

Measure	Avulux® Device n=26 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Avulux®: Avulux® device	Control/Sham Device n=29 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Sham Avulux®: Sham Avulux®
Number of Subjects With Quantifiable Improvement in Pain Score After Two Hours (First Severe Headache)	2 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 8 hours after device application

Population: The analysis population consists of the participants who experienced a minimum of one severe headache during the study and who recorded whether abortive medications were used within 8 hours of device application for their first severe headache.

Number of subjects who require abortive headache medication (e.g. analgesic or triptan) to control their first severe or very severe migraine headache (i.e. baseline pain score of 6 or higher) within 8 hours following application of the device. Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.

Outcome measures

Measure	Avulux® Device n=26 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Avulux®: Avulux® device	Control/Sham Device n=30 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Sham Avulux®: Sham Avulux®
Number of Subjects Who Require the Use of Abortive Medications (First Severe Headache)	11 Participants	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hours after device application

Population: The analysis population consists of the participants who experienced a minimum of one severe headache during the study and who recorded whether light sensitivity was experienced two hours after device application for their first severe headache.

Number of subjects suffering from light sensitivity after elapsed time of 2 hours following application of the device, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.

Outcome measures

Measure	Avulux® Device n=25 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Avulux®: Avulux® device	Control/Sham Device n=29 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Sham Avulux®: Sham Avulux®
Number of Subjects Suffering From Light Sensitivity After 2 Hours (First Severe Headache)	9 Participants	16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 hours after device application

Population: The analysis population consists of the participants who experienced a minimum of one severe headache during the study and who recorded whether light sensitivity was experienced four hours after device application for their first severe headache.

Number of subjects suffering from light sensitivity after elapsed time of 4 hours following application of the device, based on first severe or very severe migraine headache experienced by a study subject (i.e. baseline pain score of 6 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.

Outcome measures

Measure	Avulux® Device n=20 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Avulux®: Avulux® device	Control/Sham Device n=25 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Sham Avulux®: Sham Avulux®
Number of Subjects Suffering From Light Sensitivity After 4 Hours (First Severe Headache)	7 Participants	10 Participants

POST_HOC outcome

Timeframe: from baseline to 2 hours after device application

Change in migraine pain from baseline to 2 hours after device application, based on all migraine headaches experienced by a study subjects (i.e. baseline pain score of 2 or greater). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.

Outcome measures

Measure	Avulux® Device n=38 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Avulux®: Avulux® device	Control/Sham Device n=40 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Sham Avulux®: Sham Avulux®
Change in 11-point Pain Scale Score After Two Hours (All Headaches)	-1.91 score on a scale Standard Deviation 2.13	-1.05 score on a scale Standard Deviation 1.82

POST_HOC outcome

Timeframe: from baseline to 4 hours after device application

Change in migraine pain from baseline to 4 hours after device application, based on all migraine headaches experienced by a study subjects (i.e. baseline pain score of 2 or greater). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.

Outcome measures

Measure	Avulux® Device n=38 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Avulux®: Avulux® device	Control/Sham Device n=40 Participants Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Sham Avulux®: Sham Avulux®
Change in 11-point Pain Scale Score After Four Hours (All Headaches)	-3.46 score on a scale Standard Deviation 2.87	-2.10 score on a scale Standard Deviation 2.80

POST_HOC outcome

Timeframe: from baseline to 2 hours after device application

Number of headaches with associated light sensitivity after elapsed time of 2 hours following application of the device, based on all migraine headaches experienced by study subjects (i.e. baseline pain score of 2 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.

Outcome measures

Measure	Avulux® Device n=97 headaches Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Avulux®: Avulux® device	Control/Sham Device n=102 headaches Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Sham Avulux®: Sham Avulux®
Number of Headaches With Associated Light Sensitivity After 2 Hours (All Headaches)	31 headaches	63 headaches

POST_HOC outcome

Timeframe: from baseline to 4 hours after device application

Number of headaches with associated light sensitivity after elapsed time of 4 hours following application of the device, based on all migraine headaches experienced by study subjects (i.e. baseline pain score of 2 or higher). Pain scale is an 11-point scale, with integer values from 0 (no pain) to 10 (worst pain imaginable) inclusive.

Outcome measures

Measure	Avulux® Device n=84 headaches Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Avulux®: Avulux® device	Control/Sham Device n=86 headaches Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Sham Avulux®: Sham Avulux®
Number of Headaches With Associated Light Sensitivity After 4 Hours (All Headaches)	24 headaches	34 headaches

Adverse Events

Avulux® Device

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control/Sham Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Avulux® Device n=38 participants at risk Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Avulux®: Avulux® device	Control/Sham Device n=40 participants at risk Subjects will be instructed to use the glasses for four weeks. They will be instructed to put the glasses on at the first signs or symptoms consistent with the onset of a migraine attack or at the first onset of aura and keep the glasses on until their headache has resolved. 11-point pain scale: Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable. Headache diary: Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study. Sham Avulux®: Sham Avulux®
Skin and subcutaneous tissue disorders Hives	2.6% 1/38 • Number of events 1 • 4 weeks	0.00% 0/40 • 4 weeks
Respiratory, thoracic and mediastinal disorders Difficulty breathing	2.6% 1/38 • Number of events 1 • 4 weeks	0.00% 0/40 • 4 weeks
Gastrointestinal disorders vomiting	2.6% 1/38 • Number of events 1 • 4 weeks	0.00% 0/40 • 4 weeks

Additional Information

Dr. Charles Posternack, President

Avulux

Phone: 833-288-5890

Email: cposternack@avulux.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institution can independently publish 12 months from completion of the Study. Investigator shall submit the manuscript of any proposed publication to Sponsor at least 30 days before publication, and Sponsor shall have the right to review and comment upon the manuscript in order to protect Sponsor's Confidential Information. Upon Sponsor's request, publication shall be delayed up to 90 additional days.
• Publication restrictions are in place

Restriction type: OTHER