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

Summary

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

Timeline

Start

2026-03-10

Primary completion

2027-06-30

Completion

2027-08-31

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications