RP-008 with daily varenicline for trigeminal neuralgia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study is designed to determine the safety and tolerability of RP-008 (KRIYA-748) when given in combination with daily varenicline tartrate in people with trigeminal neuralgia. It will identify acceptable dose ranges for RP-008 and provide preliminary data on changes in pain severity and attack frequency. The trial follows phased early-stage design (Phase 1/2) to explore potential signals of efficacy while monitoring adverse events. Eligible participants are adults with unilateral TN lasting at least six months who have failed at least one standard anti-epileptic drug and can provide informed consent. The study is led by Kriya Therapeutics with collaboration at the University of Sherbrooke.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Sherbrooke
  Sherbrooke, Canada Recruiting

Study contacts

• Study coordinator: VP Medical Affairs
• Email: clinicaltrials@kriyatx.com
• Phone: 984-884-5058

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using intravenous lacosamide to treat acute pain in trigeminal neuralgia

  This study is testing if intravenous lacosamide can help relieve severe facial pain in people with trigeminal neuralgia who come to the emergency room.

  Recruiting Hospital Universitari de Bellvitge · L'Hospitalet de Llobregat, Barcelona · NCT06851910

• Comparing two types of radiofrequency treatments for trigeminal neuralgia pain

  This study is testing which type of radiofrequency treatment, bipolar or monopolar, works better for relieving pain in people with trigeminal neuralgia who haven't found relief from other medications.

  Recruiting at 2 sites Alexandria University · Alexandria and 1 other locations · NCT06779578

• Evaluating outcomes in neurosurgery using standardized measures

  This study is trying to see how different factors affect the results of brain surgeries by collecting information from patients before and after their operations.

  Recruiting at 11 sites Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Bergamo, BG and 26 other locations · NCT06724029

• Comparing two methods for treating facial pain from trigeminal neuralgia

  This study is testing whether a new combination of treatments for facial pain from trigeminal neuralgia works better than a single treatment to help adults feel less pain and improve their daily life.

  Recruiting Zagazig University · Zagazig, Sharqia Province · NCT06684275

• Exploring the link between emotion, memory, and chronic facial pain

  This study is trying to see how chronic facial pain affects memory and emotions by looking at brain changes in people with trigeminal neuralgia.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT06518421

• Evaluating Peripheral Nerve Stimulation for Postherpetic Neuralgia

  This study is testing if a new nerve stimulation treatment can help people with postherpetic neuralgia manage their pain better.

  Recruiting Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT06290661

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.