Trial Outcomes & Findings for Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder (NCT NCT04884763)

Last Updated: 2025-08-19

Results Overview

Assessment of pain severity using the Brief Pain Inventory (BPI) 4-item pain severity scale at 20 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (secondary outcome).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

20 weeks.

Results posted on

2025-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Overall Study STARTED	15	15
Overall Study 4-week Visit	12	15
Overall Study 8-week Visit	12	15
Overall Study 12-week Visit	11	13
Overall Study 16-week Visit	11	13
Overall Study 20-week Visit	9	12
Overall Study 24-week Visit	10	12
Overall Study COMPLETED	10	12
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	34.9 years n=93 Participants	34.7 years n=4 Participants	34.8 years n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	13 Participants n=4 Participants	26 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=93 Participants	12 Participants n=4 Participants	21 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	15 participants n=4 Participants	30 participants n=27 Participants
Brief Pain Inventory (BPI) pain severity	3.0 units on a scale STANDARD_DEVIATION 1.99 • n=93 Participants	2.9 units on a scale STANDARD_DEVIATION 1.35 • n=4 Participants	2.95 units on a scale STANDARD_DEVIATION 1.67 • n=27 Participants
Brief Pain Inventory (BPI) pain interference	2.31 units on a scale STANDARD_DEVIATION 1.90 • n=93 Participants	2.07 units on a scale STANDARD_DEVIATION 1.60 • n=4 Participants	2.19 units on a scale STANDARD_DEVIATION 1.73 • n=27 Participants
Pain Score	3.45 units on a scale STANDARD_DEVIATION 2.54 • n=93 Participants	3.62 units on a scale STANDARD_DEVIATION 1.85 • n=4 Participants	3.54 units on a scale STANDARD_DEVIATION 2.15 • n=27 Participants
Jaw Function Limitation Scale (JFLS-8)	1.69 units on a scale STANDARD_DEVIATION 1.21 • n=93 Participants	1.81 units on a scale STANDARD_DEVIATION 1.36 • n=4 Participants	1.75 units on a scale STANDARD_DEVIATION 1.27 • n=27 Participants
Patient Health Questionnaire (PHQ-4)	2.80 units on a scale STANDARD_DEVIATION 2.54 • n=93 Participants	2.27 units on a scale STANDARD_DEVIATION 1.75 • n=4 Participants	2.53 units on a scale STANDARD_DEVIATION 2.16 • n=27 Participants
Somatic Symptoms Scale (SSS-8)	6.80 units on a scale STANDARD_DEVIATION 4.81 • n=93 Participants	8.60 units on a scale STANDARD_DEVIATION 4.15 • n=4 Participants	7.70 units on a scale STANDARD_DEVIATION 4.51 • n=27 Participants

PRIMARY outcome

Timeframe: 20 weeks.

Population: Estimation done using mixed-model ANOVA which includes all available data from all time points for all subjects. This analysis reduces bias compared to an analysis at each time point that excludes subjects with missing data. All study subjects were included, even if they did not have data observed at the given time point. In addition to missing data shown in Participant Flow table, outcome-specific missing data for 1 additional Arm A subject at week 12 and 2 additional Arm B subjects at week 20.

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Brief Pain Inventory (BPI) Pain Severity at 20 Weeks	1.72 score on a scale Interval 0.78 to 2.65	1.42 score on a scale Interval 0.55 to 2.29

SECONDARY outcome

Timeframe: 20 weeks

Assessment of pain interference using the Brief Pain Inventory (BPI) 7-item pain intensity scale at 20 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Brief Pain Inventory (BPI) Pain Interference at 20 Weeks	1.11 score on a scale Interval 0.28 to 1.94	0.96 score on a scale Interval 0.18 to 1.74

SECONDARY outcome

Timeframe: 20 weeks

Population: Estimation done using mixed-model ANOVA which includes all available data from all time points for all subjects. This analysis reduces bias compared to an analysis at each time point that excludes subjects with missing data. All study subjects were included, even if they did not have data observed at the given time point. In addition to missing data shown in Participant Flow table, outcome-specific missing data for 4 Arm A subjects at wk 0, 1 Arm A at wk 4, 1 Arm A at wk 12, and 2 Arm B at wk 0.

Assessment of pain using average of daily reported pain scores at 20 weeks; average of daily reported scores from days \> week 16 and \<= week 20. Pain scale: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Average Daily Reported Pain Scores at 20 Weeks	1.92 score on a scale Interval 0.94 to 2.9	1.04 score on a scale Interval 0.13 to 1.94

SECONDARY outcome

Timeframe: 20 weeks

Assessment of pain using the % of days taking medication for pain at 20 weeks; percentage of days calculated from days \> week 16 and \<= week 20.Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
% of Days Taking Medication for Pain at 20 Weeks	23.0 percentage of days Interval 0.8 to 45.1	5.4 percentage of days Interval -14.4 to 25.2

SECONDARY outcome

Timeframe: 20 weeks

Assessment of pain improvement using the patient global impression of change in pain scale at 20 weeks: 1 (Better) - 7 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Pain Improvement Using the Patient Global Impression of Change in Pain at 20 Weeks	3.50 score on a scale Interval 2.59 to 4.4	3.55 score on a scale Interval 2.75 to 4.36

SECONDARY outcome

Timeframe: 20 weeks

Jaw Function Limitation Scale (JFLS-8) at 20 weeks: 0 (Better) - 10 (Worse).Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Jaw Function Limitation Scale (JFLS-8) at 20 Weeks	0.47 score on a scale Interval -0.22 to 1.16	0.48 score on a scale Interval -0.14 to 1.11

SECONDARY outcome

Timeframe: 20 weeks

Depressive and Anxiety symptoms using Patient Health Questionnaire (PHQ-4) at 20 weeks: 0 (Better) - 12 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Patient Health Questionnaire (PHQ-4) at 20 Weeks	4.42 score on a scale Interval 2.4 to 6.45	1.62 score on a scale Interval -0.29 to 3.53

SECONDARY outcome

Timeframe: 20 weeks

Assessment of somatic symptoms using the Somatic Symptoms Scale (SSS-8) at 20 weeks: 0 (Better) - 32 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Somatic Symptoms Scale (SSS-8) at 20 Weeks	6.46 score on a scale Interval 3.34 to 9.57	6.72 score on a scale Interval 3.86 to 9.57

SECONDARY outcome

Timeframe: 24 weeks.

Assessment of pain severity using the Brief Pain Inventory (BPI) 4-item pain severity scale at 24 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (primary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Brief Pain Inventory (BPI) Pain Severity at 24 Weeks	1.99 score on a scale Interval 0.89 to 3.09	1.51 score on a scale Interval 0.47 to 2.56

SECONDARY outcome

Timeframe: 24 weeks

Assessment of pain interference using the Brief Pain Inventory (BPI) 7-item pain intensity scale at 24 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Brief Pain Inventory (BPI) Pain Interference at 24 Weeks	1.23 score on a scale Interval -0.08 to 2.54	1.42 score on a scale Interval 0.19 to 2.65

SECONDARY outcome

Timeframe: 24 weeks

Population: Estimation done using mixed-model ANOVA which includes all available data from all time points for all subjects. This analysis reduces bias compared to an analysis at each time point that excludes subjects with missing data. All study subjects were included, even if they did not have data observed at the given time point. In addition to missing data shown in Participant Flow table, outcome-specific missing data for 4 Arm A subjects at wk 0, 1 Arm A at wk 4, 1 Arm A at wk 12, and 2 Arm B at wk 0.

Assessment of pain using average of daily reported pain scores at 24 weeks; average of daily reported scores from days \> week 20 and \<= week 24. Pain scale: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Average Daily Reported Pain Scores at 24 Weeks	2.01 score on a scale Interval 0.84 to 3.17	1.49 score on a scale Interval 0.41 to 2.58

SECONDARY outcome

Timeframe: 24 weeks

Assessment of pain using the % of days taking medication for pain at 24 weeks; percentage of days calculated from days \> week 20 and \<= week 24. Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
% of Days Taking Medication for Pain at 24 Weeks	13.7 percentage of days Interval -5.2 to 32.6	6.6 percentage of days Interval -10.2 to 23.5

SECONDARY outcome

Timeframe: 24 weeks

Assessment of pain improvement using the patient global impression of change in pain scale at 24 weeks: 1 (Better) - 7 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Pain Improvement Using the Patient Global Impression of Change in Pain at 24 Weeks	3.70 score on a scale Interval 2.89 to 4.52	3.56 score on a scale Interval 2.83 to 4.29

SECONDARY outcome

Timeframe: 24 weeks

Jaw Function Limitation Scale (JFLS-8) at 24 weeks: 0 (Better) - 10 (Worse).Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Jaw Function Limitation Scale (JFLS-8) at 24 Weeks	0.92 score on a scale Interval 0.18 to 1.66	1.16 score on a scale Interval 0.45 to 1.87

SECONDARY outcome

Timeframe: 24 weeks

Depressive and Anxiety symptoms using Patient Health Questionnaire (PHQ-4) at 24 weeks: 0 (Better) - 12 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Patient Health Questionnaire (PHQ-4) at 24 Weeks	3.58 score on a scale Interval 2.21 to 4.95	1.00 score on a scale Interval -0.31 to 2.31

SECONDARY outcome

Timeframe: 24 weeks

Assessment of somatic symptoms using the Somatic Symptoms Scale (SSS-8) at 24 weeks: 0 (Better) - 32 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and end of treatment at 20 weeks (additional secondary outcome).

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 Participants Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Somatic Symptoms Scale (SSS-8) at 24 Weeks	6.70 score on a scale Interval 3.46 to 9.94	5.51 score on a scale Interval 2.53 to 8.48

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Domenick Zero

Indiana University School of Dentistry

Phone: 3179877507

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Arm A n=15 participants at risk Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments: Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments	Arm B n=15 participants at risk Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments: Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
Gastrointestinal disorders Constipation	6.7% 1/15 • Number of events 2 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Skin and subcutaneous tissue disorders Wart	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Musculoskeletal and connective tissue disorders Neck pain	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Skin and subcutaneous tissue disorders Allergic reaction	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Skin and subcutaneous tissue disorders Bruise	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Nervous system disorders Facial pain	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Nervous system disorders Headache	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Skin and subcutaneous tissue disorders Itching	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 2 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Gastrointestinal disorders Food poisoning	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Skin and subcutaneous tissue disorders Burning Sensation	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Skin and subcutaneous tissue disorders Erythema	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Infections and infestations COVID-19	13.3% 2/15 • Number of events 2 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	13.3% 2/15 • Number of events 2 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
General disorders Sinus Headache	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Musculoskeletal and connective tissue disorders TMJ Pain	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Musculoskeletal and connective tissue disorders Myofascial Pain	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Infections and infestations Common cold	13.3% 2/15 • Number of events 2 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Gastrointestinal disorders Nausea	20.0% 3/15 • Number of events 3 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
General disorders Drowsiness	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Respiratory, thoracic and mediastinal disorders Bronchitis	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Musculoskeletal and connective tissue disorders Wrist sprain	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Ear and labyrinth disorders Ear infection	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Psychiatric disorders Anxiety	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Musculoskeletal and connective tissue disorders Dislocated Shoulder	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Gastrointestinal disorders Diarrhea	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
Infections and infestations Sore throat	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.
General disorders Low grade fever	0.00% 0/15 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.	6.7% 1/15 • Number of events 1 • 24 weeks Subjects were questioned regarding any general health or oral complaints and symptoms they had experienced during each visit. Any findings were documented on the AE CRF. All AEs, regardless of severity or relationship to the treatments, were recorded. In addition, other important medical events that were deemed clinically important/serious based on PI judgement were recorded as AEs.