Trial Outcomes & Findings for Erenumab-aooe for the Management of Trigeminal Neuropathic Pain. (NCT NCT05142228)
NCT ID: NCT05142228
Last Updated: 2024-03-22
Results Overview
Assessment of the efficacy of erenumab-aooe in the proportion of participants that achieve \>=30% reduction (Yes/no) in monthly (28 days) average pain score from baseline to Visit 4 (the last monthly treatment cycle), compared to placebo. The daily pain intensity score will be measured on a 11-point (0-10) numeric rating scale (NPRS) and reported in the Daily Symptom Diary (DSD). The monthly mean pain intensity score will be determined from baseline (4 weeks/28 days), for each month during the 12 weeks of treatment.
TERMINATED
PHASE2
5 participants
From Visit 0 (Baseline phase/Study day 0) to Visit 4 (Study day 112 +/- 7)
2024-03-22
Participant Flow
Subjects recruited and pre-screened at the Brotman Facial Pain clinic, University of Maryland, School of Dentistry. 05/31/2022 was the date of the first participant enrolled. Enrollment period: 05/31/2022 to 10/21/2022 Total number of subjects prescreened: 9
5 participants signed consent and enrolled. 1 completed study; 1 was found ineligible short after consent/enrollment due to medical history update; 1 lost follow up after baseline visit; 1 lost follow up after enrollment; 1 was dis-enrolled due to study closure. Baseline period consisted of 28 days/4 weeks prior randomization. Only one participant was assigned (blind/randomized) to one arm/group.
Participant milestones
| Measure |
Erenumab-aooe
Erenumab-aooe 140 mg/ml. Subcutaneous injection. Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
Other Name: Aimovig®
Erenumab-Aooe: Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
|
Placebo
Placebo. Subcutaneous injection.Administered once every 4 weeks/28 days at visit 1, visit 2 andvisit 3 for a total of 3 cycles.
Other name: Placebo
Placebo: Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erenumab-aooe for the Management of Trigeminal Neuropathic Pain.
Baseline characteristics by cohort
| Measure |
Erenumab-aooe
n=1 Participants
Erenumab-aooe 140 mg/ml. Subcutaneous injection. Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
Other Name: Aimovig®
Erenumab-Aooe: Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
|
Placebo
Placebo. Subcutaneous injection.Administered once every 4 weeks/28 days at visit 1, visit 2 andvisit 3 for a total of 3 cycles.
Other name: Placebo
Placebo: Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Visit 0 (Baseline phase/Study day 0) to Visit 4 (Study day 112 +/- 7)Population: Only one subject was randomly blinded and assigned to study drug (Erenumab-aooe). Data were not collected to report.
Assessment of the efficacy of erenumab-aooe in the proportion of participants that achieve \>=30% reduction (Yes/no) in monthly (28 days) average pain score from baseline to Visit 4 (the last monthly treatment cycle), compared to placebo. The daily pain intensity score will be measured on a 11-point (0-10) numeric rating scale (NPRS) and reported in the Daily Symptom Diary (DSD). The monthly mean pain intensity score will be determined from baseline (4 weeks/28 days), for each month during the 12 weeks of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Visit 0 (Baseline phase/Study day 0) to Visit 4 (study day 112 +/- 7)Population: Only one subject was randomly blinded and assigned to study drug (Erenumab-aooe). Data were not collected to report.
Comparison of erenumab-aooe with placebo in the reduction of pain score from baseline continuously through to the end of 12 weeks (Visit 4).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Visit 0 (Baseline phase/Study day 0) to Visit 5 ( study day 140 +/- 7)Population: Only one subject was randomly blinded and assigned to study drug (Erenumab-aooe). Data were not collected to report.
Assess the efficacy of erenumab-aooe compared to placebo on the proportion of subjects who achieved a least 30% reduction in the monthly average daily pain score from baseline to Visit 5 (follow-up/final visit).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7Population: Only one subject was randomly blinded and assigned to study drug (Erenumab-aooe). Data were not collected to report.
Efficacy of erenumab-aooe compared to placebo in improvement on burden/disability of daily activities related to trigeminal neuropathic pain (e.g. chewing, eating, talking, touching) measured by the Penn Facial Pain Scale-Revised. 12 items. The higher the score the more pain and disability.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7Population: Only one subject was randomly blinded and assigned to study drug (Erenumab-aooe). Data were not collected to report.
The GCPS includes 7 items and assesses 2 dimensions of pain, pain intensity and pain-related disability. A higher grade means a worse outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7Population: Only one subject was randomly blinded and assigned to study drug (Erenumab-aooe). Data were not collected to report.
The HADS evaluates anxiety (7 items) and depression (7 items) with a 14-item instrument assessing symptoms on a 4-point scale rated from 0 "not at all" to 3 "very often indeed". Responses provide separate scores for anxiety and depression. A higher score means a worse outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7Population: Only one subject was randomly blinded and assigned to study drug (Erenumab-aooe). Data were not collected to report.
The PGIC measures change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 0 (Baseline/study day 0) and Visit 4 (study day 112) +/- 7Population: Only one subject was randomly blinded and assigned to study drug (Erenumab-aooe). Data were not collected to report.
Blood samples will be evaluated for the presence of proinflammatory and anti-inflammatory cytokines.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 0 (Baseline/Study day 0) and Visit 4 (study day 112 +/- 7)Population: Only one subject was randomly blinded and assigned to study drug (Erenumab-aooe). Data were not collected to report.
Assessment of erenumab-aooe influence in nociceptive processing and sensitization determined with QST measurements.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 0 (Baseline/Study day 0) and Visit 4 (study day 112 +/- 7)Population: Only one subject was randomly blinded and assigned to study drug (Erenumab-aooe). Data were not collected to report.
Assessment of erenumab-aooe influence in pain sensitivity determined by PAF measurements during EEG assessment.
Outcome measures
Outcome data not reported
Adverse Events
Erenumab-aooe
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Marcela Romero Reyes
University of Maryland, School of Dentistry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place