Trial · NCT05162027
Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE)
NCT05162027, Phase 2, Terminated, University of Maryland, Baltimore; results first posted 2024-04-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE). Trials, record NCT05162027. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05162027
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE)
- NCT number
- NCT05162027
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Temporomandibular Disorders
- Interventions
- Erenumab-Aooe 70 MG in 1 mL Prefilled Syringe, Placebo
- First posted
- 2021-12-17
- Last updated
- 2024-04-02
- Results first posted
- 2024-04-02
- Limitations and caveats
- Early termination due to low enrollment rate.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of >= 30% Reduction in the Monthly Average Pain Score From Baseline to Visit 4, Compared to Placebo. | From Visit 0 (Baseline phase/study day 0) to Visit 4 (study day 112) | Assessment of the efficacy of erenumab-aooe in the proportion of participants that achieve \>=30% reduction (Yes/no) in monthly average pain score from baseline to Visit 4 (the end of last monthly treatment cycle), compared to placebo. The daily pain intensity score will be measured on a 0-100 numeric rating scale (NRS) and reported in the Daily Symptom Diary (DSD). The monthly mean pain intensity score will be determined from baseline, Visit 1/Day 28/Week 4, Visit 2/Day 56/Week 8, Visit 3/Day 84/week 12 and Visit 4/Day 112/Week 16. |
| Secondary | Change of >= 50% Reduction in Monthly TMD Pain Days, Compared to Placebo. | From Visit 0 (Baseline phase/study day 0) to Visit 5 (study day 140 +/- 7) | Assessment of the efficacy of erenumab-aooe in the proportion of participants with at least a 50% reduction (Yes/No) in monthly TMD days from baseline to Visit 5 (follow up/final visit). Definition of TMD pain day: A TMD pain day was any calendar day in which the participant experienced pain, stiffness, soreness, tenderness, in the jaw or temple area or either side being brief or continuous; and/or pain with TMJ biomechanics (chewing, mouth opening or any jaw movement; and/or pain with jaw activities (yawning, kissing, talking); and/or pain with jaw habits (chewing gum, clenching, grinding). |
| Secondary | Change of >= 30% Reduction in the Monthly Average Pain Score Compared to Placebo From Baseline to Visit 5. | From Visit 0 (Baseline phase/study day 0) to Visit 5 (Study day 140 +/- 7) | Assessment of the efficacy of erenumab-aooe in the proportion of participants who achieved a least 30% reduction in the monthly average daily pain score from baseline to Visit 5 (follow up and final study visit). The monthly mean pain intensity score will be determined from baseline, Visit 1/Day 28/Week 4, Visit 2/Day 56/Week 8, Visit 3/Day 84/week 12, Visit 4/Day 112/Week 16 and Visit 5/Day 140/Week 20. |
| Secondary | Change in Pressure Pain Threshold (PPT) Measurement in Muscles of Mastication (Temporalis Muscle) Compared to Placebo From Baseline to Visit 5. | Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7) | Assessments of pressure stimuli will be performed in the temporalis muscle and averaged to obtain a single pressure pain threshold value (kPa) per site. This assessment will be performed bilaterally in each temporalis muscle. A higher value means a better outcome. |
| Secondary | Change in Pressure Pain Threshold (PPT) Measurement in Muscles of Mastication (Masseter Muscle) Compared to Placebo From Baseline to Visit 5. | Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7) | Assessments of pressure stimuli will be performed in the masseter muscle and averaged to obtain a single pressure pain threshold value (kPa) per site. This assessment will be performed bilaterally in each masseter muscle. A higher PPT value means a better outcome. |
| Secondary | Change in Pressure Pain Threshold (PPT) Measurement in Upper Trapezius Muscle Compared to Placebo From Baseline to Visit 5. | Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7) | Assessments of pressure stimuli will be performed in the upper trapezius muscle and averaged to obtain a single pressure pain threshold value (kPa) per site (R/L side). This assessment will be performed bilaterally. A higher PPT value means a better outcome. |
| Secondary | Change in Pressure Pain Threshold (PPT) Measurement in the Temporomandibular Joint (TMJ) Compared to Placebo From Baseline to Visit 5. | Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7) | Assessments of pressure stimuli will be performed in the TMJ and averaged to obtain a single pressure pain threshold value (kPa) per site. This assessment will be performed bilaterally. A higher PPT value means a better outcome. |
| Secondary | Change in Pressure Pain Threshold (PPT) Measurement at the Lateral Epicondyle Compared to Placebo From Baseline to Visit 5. | Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7) | Assessments of pressure stimuli will be applied bilaterally in the right and left lateral epicondyles and averaged to obtain a single pressure pain threshold value (kPa) per site. A higher PPT value means a better outcome. |
| Secondary | Change in Maximum Unassisted Jaw Opening During Erenumab-aooe Treatment, After Treatment and Compared to Placebo. | Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7) | Measured during TMD examination. A higher value means a better outcome |
| Secondary | Change in Maximum Pain Free Opening During Erenumab-aooe Treatment, After Treatment and Compared to Placebo. | Visit 0 (baseline/study day 0) to Visit 5/week 20 (Study day 140 +/- 7) | Measured during TMD examination. A higher value means a better outcome |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change of >= 30% Reduction in the Monthly Average Pain Score From Baseline to Visit 4, Compared to Placebo. | From Visit 0 (Baseline phase/study day 0) to Visit 4 (study day 112) | Only one subject randomly blinded assigned to placebo completed the study. Data were not collected to report. | ||
| SECONDARY | Change of >= 50% Reduction in Monthly TMD Pain Days, Compared to Placebo. | From Visit 0 (Baseline phase/study day 0) to Visit 5 (study day 140 +/- 7) | Only one subject randomly blinded assigned to placebo completed the study. Data were not collected to report. | ||
| SECONDARY | Change of >= 30% Reduction in the Monthly Average Pain Score Compared to Placebo From Baseline to Visit 5. | From Visit 0 (Baseline phase/study day 0) to Visit 5 (Study day 140 +/- 7) | Only one subject randomly blinded assigned to placebo completed the study. Data were not collected to report. | ||
| SECONDARY | Change in Pressure Pain Threshold (PPT) Measurement in Muscles of Mastication (Temporalis Muscle) Compared to Placebo From Baseline to Visit 5. | Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7) | Only one subject randomly blinded assigned to placebo completed the study. Data were not collected to report. | ||
| SECONDARY | Change in Pressure Pain Threshold (PPT) Measurement in Muscles of Mastication (Masseter Muscle) Compared to Placebo From Baseline to Visit 5. | Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7) | Only one subject randomly blinded assigned to placebo completed the study. Data were not collected to report. | ||
| SECONDARY | Change in Pressure Pain Threshold (PPT) Measurement in Upper Trapezius Muscle Compared to Placebo From Baseline to Visit 5. | Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7) | Only one subject randomly blinded assigned to placebo completed the study. Data were not collected to report. | ||
| SECONDARY | Change in Pressure Pain Threshold (PPT) Measurement in the Temporomandibular Joint (TMJ) Compared to Placebo From Baseline to Visit 5. | Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7) | Only one subject randomly blinded assigned to placebo completed the study. Data were not collected to report. | ||
| SECONDARY | Change in Pressure Pain Threshold (PPT) Measurement at the Lateral Epicondyle Compared to Placebo From Baseline to Visit 5. | Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7) | Only one subject randomly blinded assigned to placebo completed the study. Data were not collected to report. | ||
| SECONDARY | Change in Maximum Unassisted Jaw Opening During Erenumab-aooe Treatment, After Treatment and Compared to Placebo. | Visit 0 (baseline/study day 0) to Visit 5/Week 20 (Study day 140 +/- 7) | Only one subject randomly blinded assigned to placebo completed the study. Data were not collected to report. | ||
| SECONDARY | Change in Maximum Pain Free Opening During Erenumab-aooe Treatment, After Treatment and Compared to Placebo. | Visit 0 (baseline/study day 0) to Visit 5/week 20 (Study day 140 +/- 7) | Only one subject randomly blinded assigned to placebo completed the study. Data were not collected to report. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Erenumab-aooe | 1 | |
| Overall Study | STARTED | Placebo | 1 | |
| Overall Study | COMPLETED | Erenumab-aooe | 0 | |
| Overall Study | COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Erenumab-aooe | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Other | Gastrointestinal disorders | Erenumab-aooe | 1 | 1 | 1 |
| other | Other | Gastrointestinal disorders | Placebo | 0 | 1 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erenumab-aooe | 0 | 1 |
| Total, all-cause mortality | Placebo | 0 | 1 |
| Total, other adverse events | Erenumab-aooe | 1 | 1 |
| Total, other adverse events | Placebo | 0 | 1 |
| Total, serious adverse events | Erenumab-aooe | 0 | 1 |
| Total, serious adverse events | Placebo | 0 | 1 |
Source ClinicalTrials.gov
Papers39
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 |
|---|---|
| Erenumab-aooe vs Placebo: deaths from any cause | Trial comparisons |
| Erenumab-aooe vs Placebo: 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/NCT05162027
GET https://conductscience.org/api/trials/v1/NCT05162027/papers?page=2