RecruitingPHASE1, PHASE2INTERVENTIONAL

RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia

This research study is investigating a new treatment approach for trigeminal neuralgia, a condition that causes sudden, severe facial pain. The study combines a new drug called RP-008 with a medication already in use, varenicline. Researchers want to understand if this blend of treatments is safe for patients, how well people can tolerate it, and if it's effective in relieving pain and reducing the frequency of painful attacks. They will also be looking at different doses of RP-008 to find the best and safest amount. This is an early-stage study, meaning it's one of the first times this combination is being tested in people. The goal is to find better ways to help those living with this challenging pain condition.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Kriya Therapeutics, Inc.

Enrolment target

Start

01 Aug 2026

Estimated completion

01 Feb 2029

Trigeminal Neuralgia

What is this study about?

This research trial is focusing on trigeminal neuralgia (TN), a condition causing very intense, sudden pain in the face, often described as an electric shock. The goal of this study is to explore a new way to treat this pain using a combination of two medications: a new drug called RP-008 and varenicline, which is a medication that's already known. Researchers want to understand if taking these two medicines together is safe and if it helps to ease the severe facial pain and reduce how often these painful attacks happen.

At this stage, the study is in its early phases (Phase 1 and Phase 2). This means that while some initial tests might have been done, this is often one of the first few times this combination is being tested in people. The researchers will be carefully checking for any side effects and how well people tolerate the treatment. They will also be looking at different amounts (doses) of RP-008 to find out which dose is safe and effective.

Understanding how RP-008 and varenicline work together is important because trigeminal neuralgia can be very difficult to manage, and current treatments don't work for everyone or can have unpleasant side effects. By conducting this study, doctors hope to gather valuable information that could lead to more effective and tolerable treatments for people living with this challenging condition in the future.

Key takeaways

This study evaluates a new combination treatment (RP-008 + varenicline) for trigeminal neuralgia.
The main goals are to check the treatment's safety, how well it's tolerated, and if it helps reduce facial pain and attacks.
It's an early-stage study, meaning the treatment is still being explored.
Participants must have one-sided trigeminal neuralgia and have tried other medications that didn't work well.
Joining a study is voluntary, and you can stop at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old and have a confirmed diagnosis of trigeminal neuralgia that has been present for at least six months. Your pain must affect only one side of your face, specifically in the cheek/upper jaw or lower jaw area, and fit the common descriptions of trigeminal neuralgia. You should also have tried at least one standard anti-epileptic medication for your pain, like carbamazepine or gabapentin, but found it didn't work well enough, or you couldn't tolerate its side effects. If you're currently taking other anti-epileptic medications for TN, you'll need to have been on a steady dose for at least six weeks before the study starts.

You cannot join this study if you experience pain on both sides of your face. Similarly, if your trigeminal neuralgia is due to another medical problem like a tumour or multiple sclerosis, or if you have certain other types of facial pain (like cluster headaches or specific types of short-lasting headaches), this study isn't suitable for you. Also, if medications that block sodium channels (a type of pain relief) haven't helped your pain at all at a proper dose, you wouldn't be able to 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 80 years old?
Has a doctor formally diagnosed you with trigeminal neuralgia at least six months ago?
Does your pain affect only one side of your face, mainly in your cheek or jaw?
Have standard trigeminal neuralgia medications (like carbamazepine) not worked well enough for you or caused difficult side effects?
Is your trigeminal neuralgia not caused by another medical condition (like a tumour or MS)?
Have you *not* had pain on both sides of your face?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part in this study involves isn't fully provided in the summary. However, generally, participating in a clinical trial like this would typically involve an initial screening visit to ensure you meet all the criteria. If you qualify, you would then likely have regular visits to the clinic for medical check-ups, to receive the study medications (RP-008 and varenicline), and to have various assessments. These assessments might include discussing your pain levels and how often you experience attacks, potentially filling out questionnaires, and undergoing physical examinations or blood tests. You would be given instructions on how to take the medications. The study would also involve follow-up appointments to monitor your progress and check for any side effects. The total duration of your participation would be explained to you in detail before you decide to join.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to new medications not yet widely available, and close monitoring by medical professionals. This could mean a chance to reduce your trigeminal neuralgia pain and attacks. However, as with any medication, there are potential risks, and side effects from the new drug (RP-008) or the combination with varenicline are possible, and their full extent won’t be known until after the study concludes. Your health will be carefully monitored throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Kriya Clinical Study Site
Verified postcode
Sherbrooke, Canada· Recruiting

Common questions

What is trigeminal neuralgia?

It's a condition that causes very intense, sudden pain in parts of the face, often feeling like an electric shock.

What are RP-008 and varenicline?

RP-008 is a new drug being tested, and varenicline is an existing medication. This study is looking at them together.

Why combine these two drugs?

Researchers want to see if using a new drug (RP-008) with an existing one (varenicline) can be a safe and effective way to reduce trigeminal neuralgia pain.

Is this a new treatment?

Yes, this study is in an early stage (Phase 1/2), meaning it's one of the first times this specific combination is being tested in people.

What happens if I join the study?

You would take the study medications, have regular check-ups, and doctors would monitor your pain and general health very closely.

How to find out more

VP Medical Affairs

clinicaltrials@kriyatx.com 984-884-5058 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.