RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia (RELIEF)
2026年6月4日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
24
段階
- フェーズ2
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：VP Medical Affairs
- 電話番号：984-884-5058
- メール：clinicaltrials@kriyatx.com
研究場所
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Sherbrooke、カナダ
- 募集
- Kriya Clinical Study Site
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コンタクト：
- Clinical Projects Coordinator
- 電話番号：+1 819-346-1110
- メール：chus@ssss.gouv.qc.ca
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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RP-008 will be administered as a single percutaneous injection to the trigeminal ganglion.
他の名前：
Varenicline tartrate will be administered as a daily oral tablet.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal electrocardiograms (ECGs), and suicidal ideation
時間枠：12 months
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Safety of RP-008 with varenicline
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12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of responders, defined as participants with reduced TN pain score, attacks, and severity, to RP-008 with varenicline treatment
時間枠：3 and 12 months
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Efficacy of RP-008 with varenicline
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3 and 12 months
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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"
時間枠：3 and 12 months
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Efficacy of RP-008 with varenicline
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3 and 12 months
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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
時間枠：3 and 12 months
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Efficacy of RP-008 with varenicline
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3 and 12 months
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Change from baseline in Pittsburgh Sleep Quality Index (PSQI), where scores range from 0-21 and higher score indicates worse sleep quality
時間枠：3 and 12 months
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Efficacy of RP-008 with varenicline
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3 and 12 months
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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
時間枠：3 and 12 months
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Efficacy of RP-008 with varenicline
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3 and 12 months
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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
時間枠：3 and 12 months
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Efficacy of RP-008 with varenicline
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3 and 12 months
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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
時間枠：3 and 12 months
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Efficacy of RP-008 with varenicline
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3 and 12 months
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Change from baseline in 5-level EuroQual-5D (EQ-5D-5L), where scores range from 0-100 and higher scores indicate better health status
時間枠：3 and 12 months
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Efficacy of RP-008 with varenicline
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3 and 12 months
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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
時間枠：3 and 12 months
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Efficacy of RP-008 with varenicline
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3 and 12 months
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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
時間枠：3 and 12 months
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Efficacy of RP-008 with varenicline
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3 and 12 months
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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
時間枠：3 and 12 months
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Efficacy of RP-008 with varenicline
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3 and 12 months
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AAV5 anti-capsid and anti-transgene antibody titer
時間枠：12 months
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Immune response to RP-008
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12 months
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Vector shedding profile of RP-008
時間枠：12 months
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Vector shedding in plasma, urine, tears, saliva, and mucus
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12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2029年2月1日
研究の完了 (推定)
2029年2月1日
試験登録日
最初に提出
2026年4月17日
QC基準を満たした最初の提出物
2026年5月12日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月8日
QC基準を満たした最後の更新が送信されました
2026年6月4日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。