NCT07596485 RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia
| NCT ID | NCT07596485 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Kriya Therapeutics, Inc. |
| Condition | Trigeminal Neuralgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-08 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2026-08 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 headache, hemicrania continua, paroxysmal hemicrania, short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT) and short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms (SUNA). * Participants who had no change in pain after taking sodium channel blockers despite the use of a therapeutic dose for an adequate duration of time.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07596485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Trigeminal Neuralgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07596485 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07596485 currently recruiting?
Yes, NCT07596485 is actively recruiting participants. Contact the research team at clinicaltrials@kriyatx.com for enrollment information.
Where is the NCT07596485 trial being conducted?
This trial is being conducted at Sherbrooke, Canada.
Who is sponsoring the NCT07596485 clinical trial?
NCT07596485 is sponsored by Kriya Therapeutics, Inc.. The trial plans to enroll 24 participants.