RecruitingPhase 1/2

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

Canada24 participantsStarted 2026-08

Plain-language summary

The goal of this study is to evaluate if KRIYA-748 (RP-008) is safe, tolerable, and preliminary effective in treating trigeminal neuralgia (TN) when used in combination with varenicline tartrate. The study will also assess what doses of RP-008 are safe and tolerable for participants and how the severity of participants' TN pain and frequency of facial pain attacks are affected.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant is capable of providing signed informed consent. * Participant must be between 18 to 80 years of age (inclusive), at the time of signing the informed consent. * Confirmed diagnosis of classical or idiopathic TN according to the criteria of the International Classification of Headache Disorders-3rd edition (ICHD-3, 2018). * The diagnosis of TN established at least 6 months prior to Screening. * Participant has purely unilateral pain attacks limited primarily to the maxillary (V2) and/or mandibular (V3) division of the trigeminal nerve. * Participant has failed at least 1 standard of care anti-epileptic agent (e.g., carbamazepine, oxcarbazepine, pregabalin, gabapentin, phenytoin, lamotrigine). Failure to a prior anti-epileptic medication is defined as insufficient pain relief despite use of a therapeutic dose for an adequate duration of time or being unsuitable due to contraindications or intolerance to side effects. * Participant is on stable dosage of any TN anti-epileptic agent(s) for a minimum of 6 weeks prior to Screening. Exclusion Criteria: * Participant has bilateral TN pain attacks. * Participants with secondary TN, defined by ICHD-3 as TN caused by an underlying disease (e.g., tumor in the cerebellopontine angle, arteriovenous malformation, or multiple sclerosis). * Participants with facial pain not meeting the ICHD-3 diagnostic criteria for either classical or idiopathic TN, including: trigeminal autonomic cephalalgias, cluster he…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal electrocardiograms (ECGs), and suicidal ideation

Timeframe: 12 months

Trial details

NCT IDNCT07596485

SponsorKriya Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-02

Contact for this trial

VP Medical Affairs

984-884-5058 clinicaltrials@kriyatx.com

View on ClinicalTrials.gov More Trigeminal Neuralgia trials