Trial · NCT04884763
Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder
NCT04884763, Phase 2, Completed, Indiana University; results first posted 2025-08-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder. Trials, record NCT04884763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04884763
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder
- NCT number
- NCT04884763
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Temporomandibular Disorder
- Interventions
- Erenumab-aooe (EREN) 140 mg 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
- First posted
- 2021-05-13
- Last updated
- 2025-08-19
- Results first posted
- 2025-08-19
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Brief Pain Inventory (BPI) Pain Severity at 20 Weeks | 20 weeks. | 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). |
| Secondary | Brief Pain Inventory (BPI) Pain Interference at 20 Weeks | 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). |
| Secondary | Average Daily Reported Pain Scores at 20 Weeks | 20 weeks | 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). |
| Secondary | % of Days Taking Medication for Pain at 20 Weeks | 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). |
| Secondary | Pain Improvement Using the Patient Global Impression of Change in Pain at 20 Weeks | 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). |
| Secondary | Jaw Function Limitation Scale (JFLS-8) at 20 Weeks | 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). |
| Secondary | Patient Health Questionnaire (PHQ-4) at 20 Weeks | 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). |
| Secondary | Somatic Symptoms Scale (SSS-8) at 20 Weeks | 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). |
| Secondary | Brief Pain Inventory (BPI) Pain Severity at 24 Weeks | 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). |
| Secondary | Brief Pain Inventory (BPI) Pain Interference at 24 Weeks | 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). |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Brief Pain Inventory (BPI) Pain Severity at 20 Weeks | 20 weeks. | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Brief Pain Inventory (BPI) Pain Interference at 20 Weeks | 20 weeks | 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 1 additional Arm B subjects at week 20. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Average Daily Reported Pain Scores at 20 Weeks | 20 weeks | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | % of Days Taking Medication for Pain at 20 Weeks | 20 weeks | 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 4 and 1 additional Arm A subject at week 12. | percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Improvement Using the Patient Global Impression of Change in Pain at 20 Weeks | 20 weeks | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Jaw Function Limitation Scale (JFLS-8) at 20 Weeks | 20 weeks | 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 4 and 1 additional Arm A subject at week 12. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Health Questionnaire (PHQ-4) at 20 Weeks | 20 weeks | 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, 1 Arm B at week 4, and 1 Arm B at week 8. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Somatic Symptoms Scale (SSS-8) at 20 Weeks | 20 weeks | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Brief Pain Inventory (BPI) Pain Severity at 24 Weeks | 24 weeks. | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Brief Pain Inventory (BPI) Pain Interference at 24 Weeks | 24 weeks | 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 1 additional Arm B subject at week 20. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Brief Pain Inventory (BPI) Pain Severity at 20 Weeks | Arm A | 1.72 | 95% Confidence Interval 0.78 to 2.65 | score on a scale | |
| Brief Pain Inventory (BPI) Pain Severity at 20 Weeks | Arm B | 1.42 | 95% Confidence Interval 0.55 to 2.29 | score on a scale | |
| Brief Pain Inventory (BPI) Pain Interference at 20 Weeks | Arm A | 1.11 | 95% Confidence Interval 0.28 to 1.94 | score on a scale | |
| Brief Pain Inventory (BPI) Pain Interference at 20 Weeks | Arm B | 0.96 | 95% Confidence Interval 0.18 to 1.74 | score on a scale | |
| Average Daily Reported Pain Scores at 20 Weeks | Arm A | 1.92 | 95% Confidence Interval 0.94 to 2.90 | score on a scale | |
| Average Daily Reported Pain Scores at 20 Weeks | Arm B | 1.04 | 95% Confidence Interval 0.13 to 1.94 | score on a scale | |
| % of Days Taking Medication for Pain at 20 Weeks | Arm A | 23.0 | 95% Confidence Interval 0.8 to 45.1 | percentage of days | |
| % of Days Taking Medication for Pain at 20 Weeks | Arm B | 5.4 | 95% Confidence Interval -14.4 to 25.2 | percentage of days | |
| Pain Improvement Using the Patient Global Impression of Change in Pain at 20 Weeks | Arm A | 3.50 | 95% Confidence Interval 2.59 to 4.40 | score on a scale | |
| Pain Improvement Using the Patient Global Impression of Change in Pain at 20 Weeks | Arm B | 3.55 | 95% Confidence Interval 2.75 to 4.36 | score on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A | 15 | |
| Overall Study | STARTED | Arm B | 15 | |
| Overall Study | 4-week Visit | Arm A | 12 | |
| Overall Study | 4-week Visit | Arm B | 15 | |
| Overall Study | 8-week Visit | Arm A | 12 | |
| Overall Study | 8-week Visit | Arm B | 15 | |
| Overall Study | 12-week Visit | Arm A | 11 | |
| Overall Study | 12-week Visit | Arm B | 13 | |
| Overall Study | 16-week Visit | Arm A | 11 | |
| Overall Study | 16-week Visit | Arm B | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Arm A | 1 | 15 | 2 |
| other | Constipation | Gastrointestinal disorders | Arm B | 0 | 15 | 0 |
| other | Wart | Skin and subcutaneous tissue disorders | Arm A | 1 | 15 | 1 |
| other | Wart | Skin and subcutaneous tissue disorders | Arm B | 0 | 15 | 0 |
| other | Neck pain | Musculoskeletal and connective tissue disorders | Arm A | 1 | 15 | 1 |
| other | Neck pain | Musculoskeletal and connective tissue disorders | Arm B | 0 | 15 | 0 |
| other | Allergic reaction | Skin and subcutaneous tissue disorders | Arm A | 1 | 15 | 1 |
| other | Allergic reaction | Skin and subcutaneous tissue disorders | Arm B | 0 | 15 | 0 |
| other | Bruise | Skin and subcutaneous tissue disorders | Arm A | 1 | 15 | 1 |
| other | Bruise | Skin and subcutaneous tissue disorders | Arm B | 0 | 15 | 0 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | 0 | 15 |
| Total, all-cause mortality | Arm B | 0 | 15 |
| Total, other adverse events | Arm A | 9 | 15 |
| Total, other adverse events | Arm B | 7 | 15 |
| Total, serious adverse events | Arm A | 0 | 15 |
| Total, serious adverse events | Arm B | 0 | 15 |
Source ClinicalTrials.gov
Papers21
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A vs Arm B: deaths from any cause | Trial comparisons |
| Arm A vs Arm B: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04884763
GET https://conductscience.org/api/trials/v1/NCT04884763/results?page=2