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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]:
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given]:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crisugabalin Treatment Arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisugabalin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12 | The International Restless Legs Syndrome Scale (IRLS) is a 10-item scale used to assess the severity of restless legs syndrome symptoms, including urge to move, sleep disturbance, and daytime impairment. The scale ranges from 0 to 40 points, with lower scores indicating less severe symptoms and a score of 0 indicating no symptoms. This outcome measure assesses the absolute change in IRLS total score from baseline (pre-treatment) to Week 12 (end of treatment). | Baseline (pre-treatment) and Week 12 (end of treatment) |
| Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12 | The International Restless Legs Syndrome Scale (IRLS) is a 10-item scale used to assess the severity of restless legs syndrome symptoms, including urge to move, sleep disturbance, and daytime impairment. The scale ranges from 0 to 40 points, with lower scores indicating less severe symptoms. This primary efficacy endpoint is defined as the percentage of participants achieving a ≥50% reduction in IRLS total score from baseline to Week 12, which is considered a clinically meaningful treatment response. | Baseline (pre-treatment) and Week 12 (end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Restless Legs Syndrome Quality of Life (QoL-RLS) Score from Baseline to Week 12 | This outcome evaluates the effect of treatment on participants' quality of life, focusing on physical, emotional, and social functioning related to RLS symptoms. The Restless Legs Syndrome Quality of Life (QoL-RLS) scale is a disease-specific instrument designed to measure the impact of RLS on daily life. The scale ranges from 0 to 100 points, with higher scores indicating better quality of life related to RLS symptoms. This outcome measure assesses the change in QoL-RLS total score from baseline (pre-treatment) to Week 12 (end of treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Pittsburgh Sleep Quality Index (PSQI) Scores from Baseline to Week 12 | This outcome evaluates the effect of the novel calcium channel modulator on participants' sleep quality. The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-rated questionnaire that assesses sleep duration, sleep latency, sleep disturbances, and daytime dysfunction. The scale ranges from 0 to 21 points, with lower scores indicating better sleep quality. This outcome measure assesses the change in PSQI total score from baseline (pre-treatment) to Week 12 (end of treatment). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenlu Zhao | Contact | 13017688128 | 912977992@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University Affiliated Beijing Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30244828 | Background | 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. | |
| 31669730 | Background | 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. |
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This study is in the exploratory stage, and the plan for sharing individual participant data (IPD) has not yet been finalized. The decision will be made based on the study results, publication requirements, and ethical considerations at the completion of the study.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2026 | Jan 28, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 8, 2026 | Jan 28, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| Baseline (pre-treatment) and Week 12 (end of treatment) |
| Baseline (pre-treatment) and Week 12 (end of treatment） |
| Changes in Hamilton Anxiety Scale (HAMA) Scores from Baseline to Week 12 | This outcome evaluates the effect of the novel calcium channel modulator on participants' anxiety symptoms. The Hamilton Anxiety Scale (HAMA) is a 14-item clinician-rated scale that assesses the severity of anxiety symptoms and emotional well-being. The scale ranges from 0 to 56 points, with lower scores indicating less severe anxiety symptoms. This outcome measure assesses the change in HAMA total score from baseline (pre-treatment) to Week 12 (end of treatment). | Baseline (pre-treatment) and Week 12 (end of treatment） |
| Changes in Hamilton Depression Scale (HAMD) Scores from Baseline to Week 12 | This outcome evaluates the effect of the novel calcium channel modulator on participants' depressive symptoms. The Hamilton Depression Scale (HAMD) is a clinician-rated scale used to assess the severity of depressive symptoms and emotional well-being. The scale ranges from 0 to 52 points, with lower scores indicating less severe depressive symptoms. This outcome measure assesses the change in HAMD total score from baseline (pre-treatment) to Week 12 (end of treatment). | Baseline (pre-treatment) and Week 12 (end of treatment） |
| 36051162 | Background | 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. |
| 30107007 | Background | 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. |
| 25023924 | Background | 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):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17. |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |