DO YOU SUFFER FROM TMD? Join Our Study!
D
Domenick Zero, DDS, MS
Primary Investigator
Not Recruiting
18 years - 100 years
All
Phase
2
25 participants needed
1 Location
Brief description of study
DO YOU SUFFER FROM TMD (temporomandibular disorders)?
Help us test a treatment that may reduce your jaw pain and other symptoms of TMD.
Researchers at the IU School of Dentistry are looking for volunteers to take part in a study to test a medication (rimegepant) - which is already approved by the FDA for the treatment and prevention of migraine - to learn how well it works and how safe it is for treating the symptoms of TMD.
People with TMD may have:
- Pain in the face or jaw
- Reduced movement of the jaw
- Clicking in the joint during motion
Health insurance is not required to participate and the investigational drug, plus all study-related assessments and care, will be provided at no cost to you.
Detailed description of study
Who is Eligible
- Ages 18 and older (if female, must not be pregnant or breast-feeding)
- Have been diagnosed with TMD by a healthcare provider
- Have experienced jaw or temple pain in the past 30 days
- Do not have a history of trauma, surgery or radiation treatment of the head and neck
- Have not participated in any prior rimegepant trials and are not currently participating in any other clinical trials
- Willing to travel to the Oral Health Institute on IUPUI campus in Indianapolis, IN
- *Study clinicians will further assess medical history to determine eligibility
What is Involved
1) Attend one screening visit at the Oral Health Institute to determine your eligibility which includes: questionnaires, physical exam/vital signs, collection of blood and urine samples, and an ECG (electrocardiogram) to measure the electrical activity of your heart.
2) If you are eligible and choose to participate, you will be asked to do the following:
- You will be randomly assigned, like the flip of a coin, to take either 1 dose of the study drug or a placebo (You will only take the study drug once, if needed)
- Attend two additional study visits to the Oral Health Institute
- Complete an electronic diary (eDiary) and paper medication log
- Total study participation may last up to 66 days
Compensation
- You will receive $100 cash for attending the screening visit, whether you qualify or not.
- You will receive $100 for completing each of the 2 remaining visits for a total study payment of $300 if you complete the entire study.
- You will be compensated an additional $100 if you complete 2 out of the 9 eDiary assessments.
How to Participate
**IF YOU ARE INTERESTED IN PARTICIPATING IN THIS STUDY, please submit your information using the provided form below.
**You may also reach out to the Study Coordinator, Mabel Molina, directly at (317) 278-4420 or email mmmolina@iu.edu
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Temporomandibular Disorders,TMD
-
Age: 18 years - 100 years
-
Gender: All
Additional Criteria:
- Have been diagnosed with TMD by a healthcare provider
- Have experienced jaw or temple pain in the past 30 days
- Do not have a history of trauma, surgery or radiation treatment of the head and neck
- Have not participated in any prior rimegepant trials and are not currently participating in any other clinical trials
- Willing to travel to the Oral Health Institute on IUPUI campus in Indianapolis, IN
- *Study clinicians will further assess medical history to determine eligibility
Study Title: Biohaven TMD Study: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Temporomandibular Disorders (TMD)
Updated on
01 Aug 2024.
Study ID: 15564
