Recruiting
Phase 1
Phase 2

KRIYA-748 & Varenicline

Sponsor:

Kriya Therapeutics, Inc.

Code:

NCT07596485

Conditions

Trigeminal Neuralgia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

RP-008

Varenicline tartrate

Study Details

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.

Conditions

Trigeminal Neuralgia

Study ID

NCT07596485

Start date

Aug, 2026

Status verified date

Jun, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants receiving RP-008

Participants will receive a single dose of RP-008 on Day 1 at varying dose levels according to the dose escalation study design. In addition, varenicline tartrate and oral corticosteroid (equivalent to prednisone or prednisolone) will be administered during the pre- and post-treatment follow-up periods.

Interventions

RP-008

RP-008 will be administered as a single percutaneous injection to the trigeminal ganglion.

Varenicline tartrate

Varenicline tartrate will be administered as a daily oral tablet.

Primary outcome measure

  • Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal electrocardiograms (ECGs), and suicidal ideation [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

VP Medical Affairs

984-884-5058clinicaltrials@kriyatx.com

Locations

Kriya Clinical Study Site

Recruiting

Sherbrooke, Canada

Contacts

Clinical Projects Coordinator

+1 819-346-1110chus@ssss.gouv.qc.ca

More Information

Sponsor

Kriya Therapeutics, Inc.

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kriya Therapeutics, Inc. on 2026-06-08.