Trigeminal NeuralgiaPhase 1/2RELIEFNCT07596485
RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia
A Phase 1/2 study testing RP-008 and Varenicline tartrate in people with Trigeminal Neuralgia, run by Kriya Therapeutics, Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- RP-008 and Varenicline tartrate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 10 Sep 2026to Feb 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Sherbrooke
Sherbrooke
Clinical Projects Coordinator, +1 819-346-1110 ext. 12889, pec.crchus.chus@ssss.gouv.qc.ca
About this study
Official 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)
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
- Being tested
- RP-008, Varenicline tartrate
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP-008Genetic
Also called KRIYA-748
RP-008 will be administered as a single percutaneous injection to the trigeminal ganglion.
Varenicline tartrateDrug
Also called Champix
Varenicline tartrate will be administered as a daily oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving RP-008 | Experimental | 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. Receives: Genetic: RP-008; Drug: Varenicline tartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal electrocardiograms (ECGs), and suicidal ideation
Safety of RP-008 with varenicline
Measured: 12 months
Secondary outcomes (13)
Number of responders, defined as participants with reduced TN pain score, attacks, and severity, to RP-008 with varenicline treatment
Efficacy of RP-008 with varenicline
Measured: 3 and 12 months
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"
Efficacy of RP-008 with varenicline
Measured: 3 and 12 months
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
Efficacy of RP-008 with varenicline
Measured: 3 and 12 months
Change from baseline in Pittsburgh Sleep Quality Index (PSQI), where scores range from 0-21 and higher score indicates worse sleep quality
Efficacy of RP-008 with varenicline
Measured: 3 and 12 months
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
Efficacy of RP-008 with varenicline
Measured: 3 and 12 months
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
Efficacy of RP-008 with varenicline
Measured: 3 and 12 months
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
Efficacy of RP-008 with varenicline
Measured: 3 and 12 months
Change from baseline in 5-level EuroQual-5D (EQ-5D-5L), where scores range from 0-100 and higher scores indicate better health status
Efficacy of RP-008 with varenicline
Measured: 3 and 12 months
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
Efficacy of RP-008 with varenicline
Measured: 3 and 12 months
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
Efficacy of RP-008 with varenicline
Measured: 3 and 12 months
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
Efficacy of RP-008 with varenicline
Measured: 3 and 12 months
AAV5 anti-capsid and anti-transgene antibody titer
Immune response to RP-008
Measured: 12 months
Vector shedding profile of RP-008
Vector shedding in plasma, urine, tears, saliva, and mucus
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start10 Sep 2026
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kriya Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596485
- Sponsor's protocol ID
- KT74863-101
- Acronym
- RELIEF
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07596485
- Acronym / sponsor ID
- RELIEF / KT74863-101
- Conditions
- Trigeminal Neuralgia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kriya Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving RP-008 | Experimental | Genetic: RP-008, Drug: Varenicline tartrateParticipants 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 may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RP-008Also: KRIYA-748RP-008 will be administered as a single percutaneous injection to the trigeminal ganglion. | Genetic | Participants receiving RP-008 |
| Varenicline tartrateAlso: ChampixVarenicline tartrate will be administered as a daily oral tablet. | Drug | Participants receiving RP-008 |
Primary outcome
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
13 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
AAV5 anti-capsid and anti-transgene antibody titer
Time frame: 12 months
Vector shedding profile of RP-008
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RP-008 and Varenicline tartrate in people with Trigeminal Neuralgia, run by Kriya Therapeutics, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VP Medical Affairs (984-884-5058, clinicaltrials@kriyatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.