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NCT Number: NCT07596485

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

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.

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Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RP-008

Genetic

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

Other names: KRIYA-748

varenicline tartrate

Drug

Varenicline tartrate will be administered as a daily oral tablet.

Other names: Champix

Primary outcomes

  1. 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

    Safety of RP-008 with varenicline

Secondary outcomes

  1. Number of responders, defined as participants with reduced TN pain score, attacks, and severity, to RP-008 with varenicline treatment

    Time frame: 3 and 12 months

    Efficacy of RP-008 with varenicline

  2. Change in pain as assessed by the 11-point Numerical Pain Rating Scale (NRS), where 0 corresponds to "no pain" and 10 corresponds to "pain as bad as you can imagine"

    Time frame: 3 and 12 months

    Efficacy of RP-008 with varenicline

  3. Change in pain as assessed by the Brief Pain Inventory (BPI) Pain Interference (PI) sub-scale, where 0 corresponds to pain having no interference with daily activities and 10 corresponds to pain interfering completely with daily activities

    Time frame: 3 and 12 months

    Efficacy of RP-008 with varenicline

  4. Change from baseline in Pittsburgh Sleep Quality Index (PSQI), where scores range from 0-21 and higher score indicates worse sleep quality

    Time frame: 3 and 12 months

    Efficacy of RP-008 with varenicline

  5. Change from baseline in Hospital Anxiety and Depression Scale (HADS), where sub-scale scores range from 0-21 and higher score indicates greater symptom severity

    Time frame: 3 and 12 months

    Efficacy of RP-008 with varenicline

  6. Change from baseline in Work Productivity and Activity Impairment (WPAI): Neuropathic Pain v2.0, where scores are expressed as 0-100% and higher percentage indicates greater impairment

    Time frame: 3 and 12 months

    Efficacy of RP-008 with varenicline

  7. Change from baseline in Penn Facial Pain Scale Revised (Penn-FPS-R), where scores range from 0-120 and higher score indicates greater pain-related disability

    Time frame: 3 and 12 months

    Efficacy of RP-008 with varenicline

  8. Change from baseline in 5-level EuroQual-5D (EQ-5D-5L), where scores range from 0-100 and higher scores indicate better health status

    Time frame: 3 and 12 months

    Efficacy of RP-008 with varenicline

  9. Change from baseline in Patient Global Assessment of TN (PGA-TN), where scores range from 1 to 5 and higher score indicates higher severity of symptoms and inability to carry out normal activities

    Time frame: 3 and 12 months

    Efficacy of RP-008 with varenicline

  10. Change from baseline in Modified Barrow Neurological Institute Pain Intensity Score (BNI), where scores range from I to V and higher score indicates higher pain and need for medication

    Time frame: 3 and 12 months

    Efficacy of RP-008 with varenicline

  11. Improvement in Patient Global Impression of Change (PGIC) and Clinician Global Impression of Change (CGIC) scale, where scores range from 1 to 7 and higher score indicates worsening of status

    Time frame: 3 and 12 months

    Efficacy of RP-008 with varenicline

  12. AAV5 anti-capsid and anti-transgene antibody titer

    Time frame: 12 months

    Immune response to RP-008

  13. Vector shedding profile of RP-008

    Time frame: 12 months

    Vector shedding in plasma, urine, tears, saliva, and mucus

Study contacts

Contact information is provided by the study sponsor or research team.

VP Medical Affairs

CONTACT

[email protected]

984-884-5058

Sponsors and collaborators

Lead sponsor

Kriya Therapeutics, Inc.

Industry

Registry information

Official study title

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)

Acronym: RELIEF

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 19, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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