Who is eligible for clinical trial NCT07596485?

Participants must meet the protocol's inclusion criteria for Trigeminal Neuralgia. The stated age range is 18 Years to 80 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07596485 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-04

RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia (NCT07596485)

A Phase 1/2, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, and PRELIminary EFficacy of Percutaneous Injection of RP-008 Followed by Daily Oral Varenicline in Patients With Trigeminal Neuralgia (The RELIEF Study)

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Kriya Therapeutics, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (5 items).

Location: Kriya Clinical Study Site — Sherbrooke

Age range: 18 Years to 80 Years

🧪 Interventions in This Study

Varenicline tartrate (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Kriya Clinical Study Site — Sherbrooke,

📞 Contact the Study Coordinator

Phone: (984) 884-5058

Email: clinicaltrials@kriyatx.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Trigeminal Neuralgia

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Emotion and Memory in Chronic Neuropathic Pain — Toronto, Ontario
Post-Operative Trigeminal Pain After Microvascular Decompression for Trigeminal Neuralgia — Newark, New Jersey
Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion — Sherbrooke, Quebec

Explore by condition: All Trigeminal Neuralgia clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗