Novel Calcium Channel Modulators in RLS and Variants: Efficacy & Safety

Официальное название

Observation of Efficacy and Safety of Novel Calcium Channel Modulators in the Treatment of Restless Legs Syndrome and Its Variant Subtypes

Обзор

The goal of this \[study type: clinical trial\] is to \[primary purpose: evaluate the efficacy and safety of a novel calcium channel modulator in treating Restless Legs Syndrome (RLS) and its variant subtypes\] in \[describe participant population/primary condition: adult patients aged 18-75 years with confirmed RLS or its variant subtypes, who meet the study's eligibility criteria\]. The main question\[s\] it aims to answer \[is/are\]: * Does the novel calcium channel modulator improve RLS-related symptoms (assessed by the International Restless Legs Syndrome Study Group Rating Scale, IRLS) after the treatment period? * What is the safety profile (incidence of adverse events) of this calcium channel modulator in RLS patients? Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given\]: * Receive oral administration of the novel calcium channel modulator (40mg twice daily) for 12 consecutive weeks * Complete scheduled follow-up visits for symptom assessments, safety monitoring, and questionnaire completion

Вмешательства

• Препарат Crisugabalin
  Participants will receive oral administration of Crisugabalin for 12 consecutive weeks. No other drugs affecting RLS symptoms will be allowed during the study. Clinical assessments and safety monitoring will be conducted at scheduled follow-up visits.

Первичные конечные точки

• Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12 [Срок оценки: Baseline (pre-treatment) and Week 12 (end of treatment)]
• Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12 [Срок оценки: Baseline (pre-treatment) and Week 12 (end of treatment)]

Вторичные конечные точки (1)

• Change in Restless Legs Syndrome Quality of Life (QoL-RLS) Score from Baseline to Week 12 [Срок оценки: Baseline (pre-treatment) and Week 12 (end of treatment)]

Критерии участия

Критерии включения

• 1\. Aged 18-75 years, regardless of gender.
• 2\. Meets the diagnostic criteria for typical Restless Legs Syndrome (RLS) (IRLSSG criteria) or variant RLS confirmed by a neurologist.
• 3\. Moderate to severe RLS (IRLS score ≥11).
• 4\. Able to understand and comply with the study protocol, and provides written informed consent.

Критерии исключения

• 1\. Secondary RLS (e.g., iron deficiency anemia with serum ferritin <30μg/L, renal dysfunction with eGFR <30ml/min, pregnancy/lactation, drug-induced RLS with unadjustable medications).
• 2\. Severe central nervous system diseases (e.g., status epilepticus, severe dementia, stroke within 3 months).
• 3\. Severe cardiovascular diseases (e.g., congestive heart failure, uncontrolled hypertension with SBP≥180mmHg or DBP≥110mmHg).
• 4\. Severe liver or kidney dysfunction (ALT/AST >3×ULN, eGFR <30mL/min/1.73m²).
• 5\. Active mental illnesses (e.g., schizophrenia, acute bipolar disorder).
• 6\. Hypersensitivity to Keligabalin Benzenesulfonic Acid or its excipients.
• 7\. Participation in other clinical trials within 1 month, inability to cooperate with follow-up, or history of substance abuse.
• 8\. Pregnancy or lactation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Capital Medical University Affiliated Beijing Friendship Hospital — Пекин

Публикации

• Trenkwalder C, Allen R, Hogl B, Clemens S, Patton S, Schormair B, Winkelmann J. Comorbidities, treatment, and pathophysiology in restless legs syndrome. Lancet Neurol. 2018 Nov;17(11):994-1005. doi: 10.1016/S1474-4422(18)30311-9. Epub 2018 Sep 21. PMID 30244828
• Suzuki K, Suzuki S, Miyamoto M, Miyamoto T, Matsubara T, Nozawa N, Arikawa T, Nakajima I, Hirata K. Involvement of legs and other body parts in patients with restless legs syndrome and its variants. J Neurol Sci. 2019 Dec 15;407:116519. doi: 10.1016/j.jns.2019.116519. Epub 2019 Oct 20. PMID 31669730
• Ishizuka K, Ohira Y. Restless Chest Syndrome: A Rare Variant of Restless Legs Syndrome. Eur J Case Rep Intern Med. 2022 Jul 6;9(7):003398. doi: 10.12890/2022_003398. eCollection 2022. PMID 36051162
• Jung Y, Hassan A, St Louis EK, Robertson CE. Restless mouth syndrome. Neurol Clin Pract. 2017 Jun;7(3):e29-e30. doi: 10.1212/CPJ.0000000000000280. No abstract available. PMID 30107007
• Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8 PMID 25023924

Идентификаторы

NCT: NCT07453862 · BFH20251127008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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