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

4 juni 2026 uppdaterad av: Kriya Therapeutics, Inc.

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

24

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kanada
      • Sherbrooke, Kanada
        • Rekrytering
        • Kriya Clinical Study Site
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Participants receiving RP-008
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.
Genetisk: RP-008
RP-008 will be administered as a single percutaneous injection to the trigeminal ganglion.
Andra namn:
  • KRIYA-748
Läkemedel: Varenicline tartrate
Varenicline tartrate will be administered as a daily oral tablet.
Andra namn:
  • Champix

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal electrocardiograms (ECGs), and suicidal ideation
Tidsram: 12 months
Safety of RP-008 with varenicline
12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of responders, defined as participants with reduced TN pain score, attacks, and severity, to RP-008 with varenicline treatment
Tidsram: 3 and 12 months
Efficacy of RP-008 with varenicline
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"
Tidsram: 3 and 12 months
Efficacy of RP-008 with varenicline
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
Tidsram: 3 and 12 months
Efficacy of RP-008 with varenicline
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
Tidsram: 3 and 12 months
Efficacy of RP-008 with varenicline
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
Tidsram: 3 and 12 months
Efficacy of RP-008 with varenicline
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
Tidsram: 3 and 12 months
Efficacy of RP-008 with varenicline
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
Tidsram: 3 and 12 months
Efficacy of RP-008 with varenicline
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
Tidsram: 3 and 12 months
Efficacy of RP-008 with varenicline
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
Tidsram: 3 and 12 months
Efficacy of RP-008 with varenicline
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
Tidsram: 3 and 12 months
Efficacy of RP-008 with varenicline
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
Tidsram: 3 and 12 months
Efficacy of RP-008 with varenicline
3 and 12 months
AAV5 anti-capsid and anti-transgene antibody titer
Tidsram: 12 months
Immune response to RP-008
12 months
Vector shedding profile of RP-008
Tidsram: 12 months
Vector shedding in plasma, urine, tears, saliva, and mucus
12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Kriya Therapeutics, Inc.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

1 februari 2029

Avslutad studie (Beräknad)

1 februari 2029

Studieregistreringsdatum

Först inskickad

17 april 2026

Först inskickad som uppfyllde QC-kriterierna

12 maj 2026

Första postat (Faktisk)

19 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KT74863-101

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

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