Trigeminal Neuralgia
Conditions
Brief 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. 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.
Interventions
GENETICRP-008
RP-008 will be administered as a single percutaneous injection to the trigeminal ganglion.
Varenicline tartrate will be administered as a daily oral tablet.
Sponsors
Kriya Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 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.
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal electrocardiograms (ECGs), and suicidal ideation | 12 months | Safety of RP-008 with varenicline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of responders, defined as participants with reduced TN pain score, attacks, and severity, to RP-008 with varenicline treatment | 3 and 12 months | Efficacy of RP-008 with varenicline |
| 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" | 3 and 12 months | Efficacy of RP-008 with varenicline |
| 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 | 3 and 12 months | Efficacy of RP-008 with varenicline |
| Change from baseline in Pittsburgh Sleep Quality Index (PSQI), where scores range from 0-21 and higher score indicates worse sleep quality | 3 and 12 months | Efficacy of RP-008 with varenicline |
| 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 | 3 and 12 months | Efficacy of RP-008 with varenicline |
| 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 | 3 and 12 months | Efficacy of RP-008 with varenicline |
| 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 | 3 and 12 months | Efficacy of RP-008 with varenicline |
| Change from baseline in 5-level EuroQual-5D (EQ-5D-5L), where scores range from 0-100 and higher scores indicate better health status | 3 and 12 months | Efficacy of RP-008 with varenicline |
| 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 | 3 and 12 months | Efficacy of RP-008 with varenicline |
| 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 | 3 and 12 months | Efficacy of RP-008 with varenicline |
| 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 | 3 and 12 months | Efficacy of RP-008 with varenicline |
| AAV5 anti-capsid and anti-transgene antibody titer | 12 months | Immune response to RP-008 |
| Vector shedding profile of RP-008 | 12 months | Vector shedding in plasma, urine, tears, saliva, and mucus |
Countries
Canada
Contacts
CONTACTVP Medical Affairs
Outcome results
None listed