New combo therapy aims to calm face pain attacks
NCT ID NCT07596485
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether an injection of RP-008 followed by a daily varenicline pill is safe and can reduce pain for people with trigeminal neuralgia, a condition causing severe facial pain attacks. About 24 adults aged 18-80 with classic or idiopathic trigeminal neuralgia will receive the treatment. The main goal is to check safety and see if pain attacks become less frequent or severe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Feb 2029
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Trigeminal neuralgia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Kriya Clinical Study Site
RECRUITINGSherbrooke, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an IV Anti-Seizure drug calm the lightning bolts of trigeminal neuralgia?
- Surgery targets hidden nerve tethering in trigeminal neuralgia
- Can freezing a nerve silence the 'Suicide Disease'?
- Pain relief showdown: one drug vs. two for facial nerve pain
- Laser showdown: which light therapy zaps facial pain best?
- Massive study aims to predict brain surgery success