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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving RP-008 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP-008 | Genetic | RP-008 will be administered as a single percutaneous injection to the trigeminal ganglion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VP Medical Affairs | Contact | 984-884-5058 | clinicaltrials@kriyatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kriya Clinical Study Site | Recruiting | Sherbrooke | Canada |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Varenicline tartrate | Drug | Varenicline tartrate will be administered as a daily oral tablet. |
|
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Efficacy of RP-008 with varenicline | 3 and 12 months |
| AAV5 anti-capsid and anti-transgene antibody titer | Immune response to RP-008 | 12 months |
| Vector shedding profile of RP-008 | Vector shedding in plasma, urine, tears, saliva, and mucus | 12 months |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D011810 | Quinoxalines |