Your session is about to expire
← Back to Search
Glutamate Receptor Antagonist
Basimglurant for Trigeminal Neuralgia
Phase 2 & 3
Recruiting
Research Sponsored by Noema Pharma AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability and willingness to provide written informed consent and to comply with the study procedures.
Diagnosis of primary (classical or idiopathic (with or without paroxysms)) trigeminal neuralgia as per the ICHD3 criteria confirmed by the study neurologist.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Study Summary
This trial is testing a new drug to see if it can help people with trigeminal neuralgia, which is a very painful condition.
Who is the study for?
Adults aged 18-75 with a confirmed diagnosis of primary trigeminal neuralgia, experiencing significant pain despite current treatments. Participants must be fluent in the study language and capable of giving informed consent. Women must be non-pregnant, non-lactating, and using contraception if of childbearing potential.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of basimglurant (1.5mg - 3.5mg) for adults with trigeminal neuralgia compared to a placebo. The goal is to see if this medication can reduce the intense facial pain associated with TN.See study design
What are the potential side effects?
While specific side effects are not listed here, participants should watch for any unusual symptoms or changes in their health since basimglurant could potentially cause reactions similar to other medications used for neuropathic pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are able to give informed consent and comply with the study procedures.
Select...
I have been diagnosed with trigeminal neuralgia by a neurologist.
Select...
I am between 18 and 75 years old.
Select...
My condition is diagnosed as trigeminal neuralgia by a neurologist.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Open Label Extension: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events.
Period 1: Incidence and severity of adverse events, laboratory, vital signs and cardiovascular events.
Period 2: Time to Loss of Efficacy or pain recurrence defined as the confirmed increase in the number of weekly paroxysms or re-emergence of continuous pain and/or the need for rescue medication.
Secondary outcome measures
Open Label Extension: Frequency of attacks (paroxysms).
Open Label Extension: Measure Global Impression of Severity as captured by PGI-S.
Open Label Extension: Severity and duration of continuous pain reported in patient pain diary.
+8 moreOther outcome measures
Period 1: Duration of continuous pain compared with BL1.
Period 1: Mean change from Period 1 baseline (BL1) to Week 8 in the total patient-rated Penn-Facial Pain Scale-Revised (Penn-FPS-R) scale.
Period 1: Measure Global Impression of change from Period 1 baseline (BL1) to Week 8.
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: BasimglurantExperimental Treatment1 Intervention
Period 1 (Run-in: Baseline1 to Week 8): Basimglurant once daily dosing starting dose 1.5mg
Period 2 (Double blind: Weeks 9 to 20): Participants will receive double-blind treatment with Basimglurant once daily.
Open-label Extension (OLE): On completion of Period 2, participants will be offered open label treatment with Basimglurant in an open label extension for up to 52 weeks.
Group II: Arm B: PlaceboPlacebo Group1 Intervention
- Period 2 (Double blind: Week 9 to Week 20): Participant randomized to placebo will receive the corresponding number of matching placebo capsules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Basimglurant
2015
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
Noema Pharma AGLead Sponsor
5 Previous Clinical Trials
363 Total Patients Enrolled
1 Trials studying Trigeminal Neuralgia
30 Patients Enrolled for Trigeminal Neuralgia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had stomach or small intestine surgery, or a condition that affects how my body absorbs nutrients.I have not taken antipsychotic medications in the last 6 months.I have been diagnosed with trigeminal neuralgia by a neurologist.I experience severe pain episodes daily for at least 2 months.I haven't had a heart attack, stroke, or major heart surgery in the last 6 months.I experience severe pain episodes daily for at least 2 months.I am between 18 and 75 years old.I am a woman who cannot become pregnant or am not currently pregnant or breastfeeding.I experience severe pain from TN with at least 3 intense episodes daily.I have a history of mania or psychosis.I do not want to stop my current nerve pain medication.My condition is diagnosed as trigeminal neuralgia by a neurologist.I have not taken basimglurant before, or I have approval to join.My liver function is not severely impaired.My kidney function is severely impaired.I don't have a major psychiatric condition unrelated to my TN.You have had an allergic reaction to the experimental drug or any of its ingredients.You have a very high body mass index (BMI), which means you are significantly overweight.I have been diagnosed with secondary trigeminal neuralgia.I am not pregnant, breastfeeding, and if able to bear children, I am using contraception.You are able to give informed consent and comply with the study procedures.I am between 18 and 75 years old.You have had a problem with drugs or alcohol in the past six months, except for using nicotine.I use opioids for pain no more than 2 days a week.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Placebo
- Group 2: Arm A: Basimglurant
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Trigeminal Neuralgia Patient Testimony for trial: Trial Name: NCT05217628 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators looking for new participants in this trial right now?
"Yes, the information available on clinicaltrials.gov seems to suggest that this trial is still recruiting patients. This particular study was posted on 1/11/2022 and updated for the last time on 11/3/2022. At present, they are looking for 200 individuals across 7 sites."
Answered by AI
How many people are allowed to take part in this experiment?
"Yes, the trial is still recruiting patients. Per the information available on clinicaltrials.gov, the study was originally posted on 1/11/2022, and the most recent update was 11/3/2022. They are looking for 200 individuals to participate at 7 different sites."
Answered by AI
Does this experimental treatment have an age limit?
"This clinical trial is available for patients aged 18-75. However, if you are under 18 there 8 other trials and if you are over 65 there 149 other trials."
Answered by AI
May I sign up for this experiment?
"This trial is investigating a new treatment for trigeminal neuralgia and thus requires participants that have been diagnosed with the condition. The study aims to recruit 200 individuals who are between 18 and 75 years old."
Answered by AI
Could you please provide me with an estimate of how many different sites are participating in this trial?
"To participate in this trial, it would be beneficial to choose the site nearest you from the 7 locations. The current cities with these sites are Tampa, Las Vegas, and Cincinnati along with other locations."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Vermont
New York
Other
How old are they?
65+
18 - 65
What site did they apply to?
Beth Israel Deaconess Medical Center (Site #: 1004)
Columbia University - Irving Medical Center (Site #: 1008)
IMA Medical Research, PC (Site #: 1005)
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I’m willing to try anything that will help with the pain. I’ve been in pain for over 9years and no dr has been able to help.
PatientReceived 2+ prior treatments
I've had two MVD with no help. The pain is unbearable. I willing to try anything.
PatientReceived 1 prior treatment
I’ve tried over three drugs that didn’t work and hoping this trial agent will reduce my severe facial painful.
PatientReceived no prior treatments
I have dealt with neuropathic pain in my face off and on for over 20 yrs. I need some relief because I am pretty much in constant pain.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long do screening take? Do you provide travel and accommodations? How long do screening visits take? Where is the trial being held?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- IMA Medical Research, PC (Site #: 1005): < 24 hours
- Beth Israel Deaconess Medical Center (Site #: 1004): < 48 hours
Average response time
- < 2 Days
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger