A Phase 1/2 interventional study of RP-008 and Varenicline tartrate in Trigeminal Neuralgia, sponsored by Kriya Therapeutics, Inc.. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Kriya Therapeutics, Inc. · Phase 1/2, Interventional, and Treatment
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.
140 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
This study's planned enrollment of 24 is below the median of 40 across 93 interventional studies indexed under Trigeminal Neuralgia.
Browse Trigeminal Neuralgia studies →Kriya Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Genetic: RP-008 · Drug: Varenicline tartrate
RP-008 will be administered as a single percutaneous injection to the trigeminal ganglion.
Also known as: KRIYA-748
Varenicline tartrate will be administered as a daily oral tablet.
Also known as: Champix
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
Time frame: 12 months
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
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"
Efficacy of RP-008 with varenicline
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
Efficacy of RP-008 with varenicline
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
Efficacy of RP-008 with varenicline
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
Efficacy of RP-008 with varenicline
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
Efficacy of RP-008 with varenicline
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
Efficacy of RP-008 with varenicline
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
Efficacy of RP-008 with varenicline
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
Efficacy of RP-008 with varenicline
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
Efficacy of RP-008 with varenicline
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
Efficacy of RP-008 with varenicline
Time frame: 3 and 12 months
AAV5 anti-capsid and anti-transgene antibody titer
Immune response to RP-008
Time frame: 12 months
Vector shedding profile of RP-008
Vector shedding in plasma, urine, tears, saliva, and mucus
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Feb 2029, 29 months after the start.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Oct 23, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Varenicline