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NCT Number: NCT07453862

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

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

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Key information

Conditions

Restless Leg Syndrome (RLS) Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Restless Legs Syndrome Sleep Disorders, Intrinsic Sleep Wake Disorders Variant Restless Legs Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12

    Time frame: Baseline (pre-treatment) and Week 12 (end of treatment)

    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).

  2. Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12

    Time frame: Baseline (pre-treatment) and Week 12 (end of treatment)

    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.

Secondary outcomes

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

    Time frame: Baseline (pre-treatment) and Week 12 (end of treatment)

    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).

Other outcomes

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

    Time frame: Baseline (pre-treatment) and Week 12 (end of treatment）

    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).

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

    Time frame: Baseline (pre-treatment) and Week 12 (end of treatment）

    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).

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

    Time frame: Baseline (pre-treatment) and Week 12 (end of treatment）

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Wenlu Zhao

CONTACT

[email protected]

13017688128

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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