RP-008 + Varenicline for Trigeminal Neuralgia

(RELIEF Trial)

Overseen By VP Medical Affairs

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Kriya Therapeutics, Inc.

Must be taking: Varenicline tartrate

Must not be taking: Sodium channel blockers

Disqualifiers: Bilateral TN, Secondary TN, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with a confirmed diagnosis of classical trigeminal neuralgia affecting one side of the face, mainly in the upper or lower jaw area. Participants must have had TN for at least 6 months and tried at least one standard medication without enough relief.

Inclusion Criteria

I am able to understand and sign a consent form.

I have tried at least one standard epilepsy medication without success or had side effects.

I have been diagnosed with classical trigeminal neuralgia by a doctor.

Exclusion Criteria

I have trigeminal neuralgia pain on both sides of my face.

My trigeminal neuralgia is caused by another disease, like a tumor or multiple sclerosis.

My facial pain does not match the criteria for trigeminal neuralgia or related headaches.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of RP-008 on Day 1 at varying dose levels, with daily oral varenicline and oral corticosteroids administered during pre- and post-treatment follow-up periods

3 months

Follow-up

Participants are monitored for safety and effectiveness, including incidence and severity of adverse events, and changes in pain and quality of life measures

12 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• RP-008
• Varenicline tartrate

Trial Overview

The study tests if RP-008 (KRIYA-748) combined with daily oral varenicline is safe and helps reduce pain in people with trigeminal neuralgia. Different doses will be studied to find what works best while monitoring safety.

How Is the Trial Designed?

Group I: Participants receiving RP-008 Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Kriya Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

60+