Trial Outcomes & Findings for Erenumab For Treatment of Hemicrania Continua (NCT NCT04303845)

NCT ID: NCT04303845

Last Updated: 2023-02-17

Results Overview

The total number of days per month (28 days) with headache of any kind/severity

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 4 weeks post erenumab treatment
• Results posted on: 2023-02-17

Participant Flow

Participant milestones

Measure	Treatment With Erenumab Subjects diagnosed with hemicrania continua received single dose of Erenumab Erenumab: 140 mg of erenumab via subcutaneous injection
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Erenumab For Treatment of Hemicrania Continua

Baseline characteristics by cohort

Measure	Treatment With Erenumab n=2 Participants Subjects diagnosed with hemicrania continua received single dose of Erenumab Erenumab: 140 mg of erenumab via subcutaneous injection
Age, Continuous	58.5 years STANDARD_DEVIATION 19.0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks post erenumab treatment

Population: Terminated study due to low enrollment

The total number of days per month (28 days) with headache of any kind/severity

Outcome measures

Measure	Treatment With Erenumab n=2 Participants Subjects diagnosed with hemicrania continua received single dose of Erenumab Erenumab: 140 mg of erenumab via subcutaneous injection
Headache Days	24.5 days Standard Deviation 4.9

SECONDARY outcome

Timeframe: 4 weeks post erenumab treatment

Population: Terminated study due to low enrollment

Total number of days per month (28 days) with migraines

Outcome measures

Measure	Treatment With Erenumab n=2 Participants Subjects diagnosed with hemicrania continua received single dose of Erenumab Erenumab: 140 mg of erenumab via subcutaneous injection
Migraine Days	0.5 days Standard Deviation 0.7

SECONDARY outcome

Timeframe: 4 weeks post erenumab treatment

Population: Terminated study due to low enrollment

Total number of days per month (28 days) with complete headache freedom

Outcome measures

Measure	Treatment With Erenumab n=2 Participants Subjects diagnosed with hemicrania continua received single dose of Erenumab Erenumab: 140 mg of erenumab via subcutaneous injection
Headache Freedom	3.5 days Standard Deviation 4.9

SECONDARY outcome

Timeframe: 4 weeks post erenumab treatment

Number of participants who do not have any occurrence of headache

Outcome measures

Measure	Treatment With Erenumab n=2 Participants Subjects diagnosed with hemicrania continua received single dose of Erenumab Erenumab: 140 mg of erenumab via subcutaneous injection
Remission Rate	0 Participants

Adverse Events

Treatment With Erenumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment With Erenumab n=2 participants at risk Subjects diagnosed with hemicrania continua received single dose of Erenumab Erenumab: 140 mg of erenumab via subcutaneous injection
General disorders Worsening of pre-existing medical condition	50.0% 1/2 • Adverse Events were collected from baseline to end of study, approximately 8 weeks.

Additional Information

Rashmi B. Halker Singh, M.D.

Mayo Clinic

Phone: 480-301-8100

Email: Halker.Rashmi@mayo.edu

Results disclosure agreements

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