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Monoclonal Antibodies

Erenumab-aooe for Trigeminal Neuropathy

Phase 2
Waitlist Available
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Provide signed and dated informed consent form
Trigeminal neuropathic pain symptoms for a minimum of 3 months prior to randomization visit, localized in any trigeminal distribution (intraoral or extraoral).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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) +/- 7
Awards & highlights

Study Summary

This trial is testing whether a new drug, erenumab-aooe, is effective in reducing pain for people with trigeminal neuropathic pain, compared to placebo. The trial will involve 40 people total, who will be randomly assigned to either receive the drug or placebo. There will be 6 clinic visits over 21 weeks, during which changes in pain intensity and other pain-related outcomes will be assessed.

Eligible Conditions
  • Trigeminal Neuropathy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 18 and 65 years of age (inclusive; male or female and any race or ethnicity).
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You have idiopathic trigeminal neuralgia with concomitant continuous pain per ICDH-3.
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You are taking prescription medication, opioid medication or OTC medications as needed or episodically for the management of pain.
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You are taking a prescription medication daily for the management of pain.
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You have a minimum mean of average daily pain intensity score of 4/10 in where 0= no pain and 10= maximum pain imaginable on a numerical rating scale (0-10), during the 4 weeks/28 days baseline period prior randomization.
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You are taking OTC pain medications daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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) +/- 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) +/- 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of >= 30% reduction in the monthly (28 days) average pain score from baseline to Visit 4, compared to placebo.
Secondary outcome measures
Change in Graded Chronic Pain Scale (GCPS) outcomes during erenumab-aooe treatment, after treatment and compared to placebo.
Change in impression of overall status measured by the Patient Global Impression of Change (PGIC) during erenumab-aooe treatment, after treatment and compared to placebo.
Change in participant ratings compared to placebo for improving physical function and health related quality of life in patients with trigeminal neuropathic pain measured by the Penn Facial Pain Scale-Revised.
+3 more
Other outcome measures
Change in nociceptive processing and sensitization determined with quantitative sensory testing (QST) measurements when compared to placebo.
Change in pain sensitivity determined by peak alpha frequency (PAF) measurements during EEG (electroencephalogram) assessment when compared to placebo.
Change of pro-inflammatory and anti-inflammatory cytokine profiles (Th1/Th2) when compared to placebo.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Erenumab-aooeActive Control1 Intervention
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®
Group II: PlaceboPlacebo Group1 Intervention
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

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
684 Previous Clinical Trials
373,104 Total Patients Enrolled
AmgenIndustry Sponsor
1,355 Previous Clinical Trials
1,384,066 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks should people be aware of when using Erenumab-aooe?

"As Erenumab-aooe is currently undergoing Phase 2 trials, the safety rating of this medication has been assessed as a score of 2. This reflects that while clinical data on its efficacy is yet to be collected, there are some studies which demonstrate it's security."

Answered by AI

Is this clinical trial a pioneering effort?

"Presently, Erenumab-aooe is the focus of 18 clinical trials distributed across 179 cities and 32 countries. The inaugural trial for this drug was commissioned by Amgen in 2019 and saw 456 participants complete its Phase 3 approval stage. Since then, a total of 18338 investigations have been initiated concerning this medication."

Answered by AI

What is the upper limit for participants in this medical trial?

"Affirmative. The clinical trial data stored on clinicaltrials.gov affirms that the study, which was launched April 1st 2022, is currently recruiting participants. A total of 40 individuals are necessary to be recruited from one medical centre."

Answered by AI

Is the age limit for this research endeavor restricted to those over thirty years of age?

"Patients eligible for this trial must be between 18 and 65 years old. For those below the age of consent, there are 10 studies available, while 155 experiments have been designed with seniors in mind."

Answered by AI

Has Erenumab-aooe been tested in any prospective investigations?

"Presently, 18 clinical studies related to Erenumab-aooe are in progress. Three of these trials have advanced to Phase 3 status. Rochester, Minnesota is the epicentre for much of this research; however, 549 sites globally offer access to treatment with this medication."

Answered by AI

Is enrollment in this experiment open to participants at the moment?

"According to clinicaltrials.gov, this ongoing recruiting process was initiated on April 1st 2022 and has been recently updated as of May 4th 2022."

Answered by AI

Is it possible for me to join this research effort?

"For entry into this clinical trial, subjects must be diagnosed with trigeminal neuropathy and range between 18 to 65 years of age. A total of 40 people will eventually be accepted."

Answered by AI

Who else is applying?

What state do they live in?
West Virginia
Pennsylvania
How old are they?
65+
What site did they apply to?
University of Maryland, School of Dentistry, Brotman Facial Pain Clinic
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. University of Maryland, School of Dentistry, Brotman Facial Pain Clinic: < 48 hours
Typically responds via
Email
~2 spots leftby Mar 2025