Trial Outcomes & Findings for Open-trial on the Prevention of Chronic Migraines With the CEFALY Device (NCT NCT02342743)

NCT ID: NCT02342743

Last Updated: 2019-06-20

Results Overview

Mean change in frequency of headache days (defined as a day with at least one headache episode, which is a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 73 participants
• Primary outcome timeframe: End of baseline period and end of 12 weeks treatment period
• Results posted on: 2019-06-20

Participant Flow

Participant milestones

Measure	Active Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY
Baseline Period STARTED	73
Baseline Period COMPLETED	58
Baseline Period NOT COMPLETED	15
Treatment Period STARTED	58
Treatment Period COMPLETED	47
Treatment Period NOT COMPLETED	11

Reasons for withdrawal

Measure	Active Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY
Baseline Period Withdrawal by Subject	3
Baseline Period Lost to Follow-up	2
Baseline Period Change in prophylactic medication	3
Baseline Period Screening failure regarding baseline	7
Treatment Period Withdrawal by Subject	2
Treatment Period Lost to Follow-up	8
Treatment Period Change in prophylactic medication	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Active n=58 Participants Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY
Age, Continuous	40.45 years STANDARD_DEVIATION 13.12 • n=58 Participants
Sex: Female, Male Female	49 Participants n=58 Participants
Sex: Female, Male Male	9 Participants n=58 Participants
Number of headache episodes	22.66 episodes STANDARD_DEVIATION 5.35 • n=58 Participants
Number of headache days	22.55 days STANDARD_DEVIATION 5.38 • n=58 Participants
Number of moderate/severe headache days	16.07 days STANDARD_DEVIATION 7.65 • n=58 Participants
Number of migraine days	19.02 days STANDARD_DEVIATION 6.36 • n=58 Participants
Cumulative hours of headache on headache days	249.64 hours STANDARD_DEVIATION 124.29 • n=58 Participants
Average headache intensity	1.98 units on a scale STANDARD_DEVIATION 0.44 • n=58 Participants
Acute medication use (total number) - all categories	26.33 medications STANDARD_DEVIATION 30.25 • n=58 Participants

PRIMARY outcome

Timeframe: End of baseline period and end of 12 weeks treatment period

Mean change in frequency of headache days (defined as a day with at least one headache episode, which is a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.

Outcome measures

Measure	Active n=58 Participants Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY
Change From Baseline in Frequency of Headache Days	-3.12 days per 28-days Standard Deviation 5.70

PRIMARY outcome

Timeframe: End of baseline period and end of 12 weeks treatment period

Overall acute headache pain medication use (all categories) mean change between the 28-day baseline and the 28-day period ending with week 12 of treatment.

Outcome measures

Measure	Active n=58 Participants Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY
Change From Baseline in Acute Medication Intake	-8.11 medications per 28-days Standard Deviation 18.74

SECONDARY outcome

Timeframe: End of baseline period and end of 12 weeks treatment period

Mean change in frequency of migraine days (any headache day is a migraine day, unless the pain intensity = 1 and there is no intake of acute anti-migraine medication) between the 28-day baseline and the 28-day period ending with week 12 of treatment.

Outcome measures

Measure	Active n=58 Participants Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY
Change in Frequency of Migraine Days	-3.35 days per 28-days Standard Deviation 6.20

SECONDARY outcome

Timeframe: End of baseline period and end of 12 weeks treatment period

Mean change in frequency of moderate/severe headache days (defined as a headache day with at least one headache episode with intensity = 2 or 3) between the 28-day baseline and the 28-day period ending with week 12 of treatment.

Outcome measures

Measure	Active n=58 Participants Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY
Change in Frequency of Moderate/Severe Headache Days	-3.10 days per 28-days Standard Deviation 5.98

SECONDARY outcome

Timeframe: End of baseline period and end of 12 weeks treatment period

Mean change in monthly cumulative headache hours on headache days between the 28-day baseline and the 28-day period ending with week 12 of treatment.

Outcome measures

Measure	Active n=58 Participants Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY
Change in Monthly Cumulative Headache Hours	-27.22 hours per 28-days Standard Deviation 80.46

SECONDARY outcome

Timeframe: End of baseline period and end of 12 weeks treatment period

Mean change in frequency of headache episodes (defined as a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.

Outcome measures

Measure	Active n=58 Participants Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY
Change in Frequency of Headache Episodes	-3.12 episodes per 28-days Standard Deviation 5.77

SECONDARY outcome

Timeframe: End of the 12 weeks treatment period

Number of subjects who observe a 50% reduction in the frequency of their migraine days between the 28-day baseline and the 28-day period ending with week 12 of treatment.

Outcome measures

Measure	Active n=58 Participants Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY
50% Responder Rate for Migraine Days	11 Participants

SECONDARY outcome

Timeframe: End of baseline period and end of 12 weeks treatment period

Mean change in the average headache intensity between the 28-day baseline and the 28-day period ending with week 12 of treatment. Headache intensity is defined on a scale from 0 (no pain) to 3 (maximum pain).

Outcome measures

Measure	Active n=58 Participants Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY
Change in the Average Headache Intensity	-0.12 units on a scale Standard Deviation 0.37

Adverse Events

Active

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active n=58 participants at risk Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY
Nervous system disorders Worsening myasthenia gravis and worsening migraine headache	1.7% 1/58 • Number of events 1 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation

Other adverse events

Measure	Active n=58 participants at risk Daily trigeminal nerve stimulation session of 20 minutes with CEFALY CEFALY
Infections and infestations Cold, sinus infection, respiratory virus, sore throat, fever, flu-like symptoms	25.9% 15/58 • Number of events 21 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation
Infections and infestations Gastroenteritis, stomach flu, norovirus	8.6% 5/58 • Number of events 7 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation
Infections and infestations Vaginal infection	1.7% 1/58 • Number of events 1 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation
Nervous system disorders Migraine, worsening headaches	8.6% 5/58 • Number of events 5 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation
Skin and subcutaneous tissue disorders Hives	3.4% 2/58 • Number of events 2 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation
Surgical and medical procedures Surgical interventions	3.4% 2/58 • Number of events 2 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation
Injury, poisoning and procedural complications Injury	3.4% 2/58 • Number of events 3 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation
Skin and subcutaneous tissue disorders Skin irritation (Dermatitis forehead)	1.7% 1/58 • Number of events 1 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation
Skin and subcutaneous tissue disorders Burning sensation on forehead	1.7% 1/58 • Number of events 1 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation
Nervous system disorders Worsening vertigo	1.7% 1/58 • Number of events 1 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation
Skin and subcutaneous tissue disorders Rash both arms and neck	1.7% 1/58 • Number of events 1 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation
Renal and urinary disorders Kidney stone pain	1.7% 1/58 • Number of events 1 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation
Musculoskeletal and connective tissue disorders Diagnosis of fibromyalgia	1.7% 1/58 • Number of events 1 • The AEs (adverse events) reported here were collected as of the first use of the device until the final visit after 12 weeks of stimulation

Additional Information

Clinical Trials Department director

CEFALY Technology

Phone: +3243676722

Email: info@cefaly.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 60 days from the time submitted to the sponsor for review. Sponsor may request: * deletion of any trade secret, proprietary, or confidential information of Sponsor * an additional 60 days to take measures to preserve its Intellectual Property rights
• Publication restrictions are in place

Restriction type: OTHER