RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia
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)
Kriya Therapeutics, Inc.
24 participants
Jun 1, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 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.
Exclusion Criteria4
- 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 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.
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Interventions
RP-008 will be administered as a single percutaneous injection to the trigeminal ganglion.
Varenicline tartrate will be administered as a daily oral tablet.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07596485