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

NCT07453862 | Recruiting Phase 1

• 1 other identifier: BFH20251127008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Restless Leg Syndrome (RLS); Variant Restless Legs Syndrome

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (1)

• Change in Restless Legs Syndrome Quality of Life (QoL-RLS) Score from Baseline to Week 12

  Baseline (pre-treatment) and Week 12 (end of treatment)

Other Outcomes (3)

• Changes in Pittsburgh Sleep Quality Index (PSQI) Scores from Baseline to Week 12

  Baseline (pre-treatment) and Week 12 (end of treatment）

• Changes in Hamilton Anxiety Scale (HAMA) Scores from Baseline to Week 12

  Baseline (pre-treatment) and Week 12 (end of treatment）

• Changes in Hamilton Depression Scale (HAMD) Scores from Baseline to Week 12

  Baseline (pre-treatment) and Week 12 (end of treatment）

Study Arms (1)

Crisugabalin Treatment Arm

EXPERIMENTAL

Drug: Crisugabalin

Interventions

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.

Crisugabalin Treatment Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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).
• \. Severe central nervous system diseases (e.g., status epilepticus, severe dementia, stroke within 3 months).
• \. Severe cardiovascular diseases (e.g., congestive heart failure, uncontrolled hypertension with SBP≥180mmHg or DBP≥110mmHg).
• \. Severe liver or kidney dysfunction (ALT/AST \>3×ULN, eGFR \<30mL/min/1.73m²).
• \. Active mental illnesses (e.g., schizophrenia, acute bipolar disorder).
• \. Hypersensitivity to Keligabalin Benzenesulfonic Acid or its excipients.
• \. Participation in other clinical trials within 1 month, inability to cooperate with follow-up, or history of substance abuse.
• \. Pregnancy or lactation.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Capital Medical University Affiliated Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (5)

• 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 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.

  PMID: 31669730 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.

  PMID: 36051162 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.

  PMID: 30107007 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.

  PMID: 25023924 BACKGROUND

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Central Study Contacts

Wenlu Zhao

CONTACT

13017688128; 912977992@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: March 6, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CN (1)