Active not recruitingPHASE2, PHASE3INTERVENTIONAL

An Efficacy and Safety Study of Basimglurant (NOE-101) in Patients With Trigeminal Neuralgia.

This research study is looking into a new medicine called basimglurant for adults aged 18 to 75 who suffer from trigeminal neuralgia (TN). TN is a very painful condition affecting the face. The main goal is to find out if basimglurant is both safe and effective at reducing the duration and intensity of facial pain experienced by people with TN. Some participants will receive the new medicine, while others will get a placebo, which looks like the real medicine but contains no active drug. This allows researchers to fairly compare the effects. Participants will keep a pain diary and answer questions about how they feel. This is a Phase 2/3 study, meaning it's still in the stages of testing efficiency and safety before it can be considered for wider use.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Noema Pharma AG

Enrolment target

166

Start

11 Jan 2022

Estimated completion

24 Apr 2027

Trigeminal Neuralgia

What is this study about?

Trigeminal neuralgia (TN) is often called one of the most painful conditions a person can experience. It causes sudden, severe, shock-like pain in the face. This study is exploring a new potential treatment called basimglurant, which is being tested in adults who have been diagnosed with TN.

Basimglurant works by targeting a specific pathway in the nervous system that is thought to be involved in pain. Researchers believe that by blocking this pathway, the medicine might help to reduce the pain associated with TN. The drug has already been looked at in other studies and seems to have a good safety record in adults and younger people.

The main aim of this study is to see if basimglurant can make a real difference to people's pain. Participants will be asked to keep a record of how often their pain occurs and how strong it is. They will also share how they feel their condition is changing overall. This will help the research team understand if the medicine is actually making the pain less frequent and less intense compared to a dummy pill.

Key takeaways

This study tests a new medicine, basimglurant, for trigeminal neuralgia pain.
It aims to see if the medicine is safe and reduces pain duration and intensity.
Participants will be between 18 and 75 years old.
Some will get the new medicine, others a dummy pill (placebo).
You'll keep a pain diary and have regular clinic visits.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be between 18 and 75 years old and have been diagnosed with primary trigeminal neuralgia. You should be experiencing at least three pain attacks per day, with each attack being at least a moderate level of pain (scoring 4 or more on a pain scale) over the last week. You must also be able to understand and agree to the study procedures and be able to communicate with the study team.

There are also some reasons why you might not be able to join. For example, if you have certain mental health conditions not related to your TN, or a history of drug or alcohol dependence in the past six months. You also can't take part if you have secondary TN (meaning your TN is caused by another condition), have had an allergic reaction to this type of medicine before, or if you're already taking certain other medications that could interfere with the study.

If you are a woman who could become pregnant, you must not be pregnant or breastfeeding and must agree to use effective contraception during the study. If you are currently taking other pain relief for your TN, you might need to stop it or change how you use it, as this could affect whether you can participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Do you have a diagnosis of primary trigeminal neuralgia?
Do you experience at least 3 pain attacks per day, with moderate or severe pain?
Are you able to speak and understand English?
Are you willing to discuss potential changes to your current TN pain medication?
Are you not pregnant or breastfeeding, and willing to use contraception if needed?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be given either the new medicine, basimglurant, or a placebo (a dummy pill that looks the same but has no active drug). You won't know which one you're receiving, and neither will the study team. You'll need to take the study medicine as instructed and keep a detailed diary of your pain, noting how often it occurs and how strong it is. You'll also answer questions about how you feel your condition is changing.

Throughout the study, you'll have several visits to the clinic for assessments and to check on your health and any side effects. The total length of your participation in the study will be explained to you by the research team. Regular follow-up appointments will ensure your safety and monitor the effects of the treatment.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit from the new medicine if it helps reduce your trigeminal neuralgia pain, and your participation will help advance medical knowledge for others with this condition. However, there's also a chance the medicine might not work for you, or you could experience side effects, even if it has been found to be safe in previous studies. Some people in the study will receive a placebo and might not experience any change in their pain. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (34)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Kaizen Brain Center (Site #: 1001)
Verified postcode
La Jolla, United States
L & A Morales Healthcare INC (Site#: 1011)
Verified postcode
Miami, United States
University of South Florida (Site #: 1002)
Verified postcode
Tampa, United States
Vista Clinical Research,LLC (Site#: 1010)
Verified postcode
Newnan, United States
Beth Israel Deaconess Medical Center (Site #: 1004)
Verified postcode
Boston, United States
Altea Research - Nevada - ClinEdge - PPDS (Site #1006)
Verified postcode
Las Vegas, United States
Columbia University - Irving Medical Center (Site #: 1008)
Verified postcode
New York, United States
University of Cincinnati (Site #: 1007)
Verified postcode
Cincinnati, United States
Danish Headache Center (Site #: 1201)
Verified postcode
Glostrup Municipality, Denmark
Universitätsklinikum Bonn (Site #: 1707)
Verified postcode
Bonn, Germany
Università Campus Bio Medico Di Roma (Site #: 1805)
Verified postcode
Rome, Italy
IRCCS San Raffaele Pisana (Site #: 1801)
Verified postcode
Rome, Italy

Common questions

What is trigeminal neuralgia (TN)?

TN is a very painful condition that causes sudden, intense facial pain, often described as electric shock-like.

What is a placebo?

A placebo is a dummy pill that looks like the real medicine but doesn't contain any active drug. It helps ensure the study results are fair.

How long will the study last?

The study team will tell you the exact duration of your participation during the screening process.

Will I know if I'm getting the active drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know until the study is over. This ensures unbiased results.

Can I continue taking my current pain medication for TN?

You might need to adjust or stop some of your current TN pain medications, depending on what they are. The study team will discuss this with you.