Trial Outcomes & Findings for Multidisciplinary Translational Approach to Investigate Mechanisms Predictors & Prevention of Persistent PTH (NCT NCT04098250)

NCT ID: NCT04098250

Last Updated: 2025-10-23

Results Overview

The number of days where subjects experienced moderate-to-severe headaches. This was measured at baseline, 9, 10, 11 and 12 weeks after administration of first dose of erenumab 140 mg or placebo. The change from baseline to week 12 is reported.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported
• Results posted on: 2025-10-23

Participant Flow

Participants were recruited from Mayo Clinic Arizona.

All subjects who participated in the study took part in the trial prior to the study team changing it to an open label study. No participants were recruited or enrolled after the study was changed to open label.

Participant milestones

Measure	Erenumab 140 mg erenumab Erenumab: a CGRP receptor monoclonal antibody	Placebo placebo comparator Placebo: Placebo
Overall Study STARTED	2	4
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Erenumab 140 mg erenumab Erenumab: a CGRP receptor monoclonal antibody	Placebo placebo comparator Placebo: Placebo
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Multidisciplinary Translational Approach to Investigate Mechanisms Predictors & Prevention of Persistent PTH

Baseline characteristics by cohort

Measure	Placebo n=4 Participants placebo comparator Placebo: Placebo	Total n=6 Participants Total of all reporting groups	Erenumab n=2 Participants 140 mg erenumab Erenumab: a CGRP receptor monoclonal antibody
Age, Continuous	42.3 years STANDARD_DEVIATION 26.0 • n=7 Participants	43.9 years STANDARD_DEVIATION 20.8 • n=5 Participants	47.2 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=7 Participants	6 participants n=5 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported

The number of days where subjects experienced moderate-to-severe headaches. This was measured at baseline, 9, 10, 11 and 12 weeks after administration of first dose of erenumab 140 mg or placebo. The change from baseline to week 12 is reported.

Outcome measures

Measure	Erenumab n=2 Participants 140 mg erenumab Erenumab: a CGRP receptor monoclonal antibody	Placebo n=3 Participants placebo comparator Placebo: Placebo
Change in the Number of Days Experiencing Moderate-to-Severe Headaches	-8 Days Standard Deviation 2.8	-0.33 Days Standard Deviation 6.0

SECONDARY outcome

Timeframe: Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported

The number of patients with at least a 50% reduction in days where they experienced a headache. This was measured at baseline, 9, 10, 11 and 12 weeks after administration of first dose of erenumab 140 mg or placebo. The change from baseline to week 12 is reported.

Outcome measures

Measure	Erenumab n=2 Participants 140 mg erenumab Erenumab: a CGRP receptor monoclonal antibody	Placebo n=3 Participants placebo comparator Placebo: Placebo
Responder Rate	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported

The number of patients with a chronic headache, defined as reporting a headache for at least 15 days. This was measured at baseline, 9, 10, 11 and 12 weeks after administration of first dose of erenumab 140 mg or placebo. The change from baseline to week 12 is reported.

Outcome measures

Measure	Erenumab n=2 Participants 140 mg erenumab Erenumab: a CGRP receptor monoclonal antibody	Placebo n=3 Participants placebo comparator Placebo: Placebo
Chronic Headache	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported

The Headache Impact Test (HIT-6) measures the impact of headaches on a person's daily life. It assesses the frequency and severity of headaches, their functional limitations and the impact on daily activities such as work, education and social interactions. The HIT-6 test has 6 questions. Each of the six questions receives a score from 6-13. The final HIT-6 score can range from 36 to 78. A higher score indicates more disability due to headache. This was measured at baseline, 9, 10, 11 and 12 weeks after administration of first dose of erenumab 140 mg or placebo. The change from baseline to week 12 is reported.

Outcome measures

Measure	Erenumab n=2 Participants 140 mg erenumab Erenumab: a CGRP receptor monoclonal antibody	Placebo n=4 Participants placebo comparator Placebo: Placebo
Change in the Headache Impact Test (HIT-6)	-7 score on a scale Standard Deviation 1.4	-1.3 score on a scale Standard Deviation 14.4

SECONDARY outcome

Timeframe: Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported

The change in the number of days where subjects underwent acute treatment to relieve a headache. Treatment days were days in which subjects took analgesic, triptan, or ergotamine containing medication, or they underwent device neuromodulation [e.g. vagal or trigeminal nerve electrical stimulation or single pulse transcranial magnetic stimulation]. This was measured at baseline,9, 10, 11 and 12 weeks after administration of first dose of erenumab 140mg or placebo. The change from baseline to 12 weeks is reported.

Outcome measures

Measure	Erenumab n=2 Participants 140 mg erenumab Erenumab: a CGRP receptor monoclonal antibody	Placebo n=3 Participants placebo comparator Placebo: Placebo
Change in the Number of Days Where Acute Treatment Was Administered to Relieve a Headache	-7.5 Days Standard Deviation 4.9	-2.7 Days Standard Deviation 4.6

Adverse Events

Erenumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Erenumab n=2 participants at risk 140 mg erenumab Erenumab: a CGRP receptor monoclonal antibody	Placebo n=4 participants at risk placebo comparator Placebo: Placebo
Injury, poisoning and procedural complications Pain at injection site/bruising at injection site	50.0% 1/2 • Number of events 2 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.	0.00% 0/4 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.
Gastrointestinal disorders Abdominal Pain	0.00% 0/2 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.	25.0% 1/4 • Number of events 1 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.
Infections and infestations Urinary Tract Infection	0.00% 0/2 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.	25.0% 1/4 • Number of events 2 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.
Infections and infestations COVID	50.0% 1/2 • Number of events 1 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.	25.0% 1/4 • Number of events 1 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.
Cardiac disorders Chest Pain	0.00% 0/2 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.	25.0% 1/4 • Number of events 1 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.
Infections and infestations Conjunctivitis	0.00% 0/2 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.	25.0% 1/4 • Number of events 1 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.
Infections and infestations Pneumonia/Bronchitis	50.0% 1/2 • Number of events 1 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.	0.00% 0/4 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.
Eye disorders Eyelid Twitching	0.00% 0/2 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.	25.0% 1/4 • Number of events 1 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.
Nervous system disorders Facial Numbness	0.00% 0/2 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.	25.0% 1/4 • Number of events 1 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.
Infections and infestations Ear Infection	0.00% 0/2 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.	25.0% 1/4 • Number of events 1 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.
Nervous system disorders Dizziness/Increased Headache	0.00% 0/2 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.	25.0% 1/4 • Number of events 1 • Adverse events were collected from the time of the first dose of investigational product through the end of the safety follow up visit, approximately 12 weeks.

Additional Information

Todd Schwedt, M.D.

Mayo Clinic

Phone: 480-301-9721

Email: Schwedt.Todd@mayo.edu

Results disclosure agreements

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