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

Kriya Therapeutics, Inc.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Trigeminal Neuralgia

Treatments: Drug: Varenicline tartrate; Genetic: RP-008

Study type: Interventional

Funder types: Industry

Identifiers

NCT07596485

KT74863-101

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Participants receiving RP-008

Experimental group

Description:

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.

Treatment:

Genetic: RP-008

Drug: Varenicline tartrate