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

Recruiting now · Phase 1/Phase 2

Conditions studied: Trigeminal Neuralgia

In brief

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.

Key facts

Study ID

NCT07596485

Run by

Kriya Therapeutics, Inc.

People needed

24

Starts

2026-08-01

Expected to finish

2029-02-01

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kriya Clinical Study Site — Sherbrooke, Canada (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.