Crisugabalin for restless legs and variant restless legs

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

This phase 1 trial will test whether crisugabalin (40 mg twice daily) can reduce symptoms in adults aged 18–75 with moderate to severe restless legs syndrome or its variants over 12 weeks.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Friendship Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07453862 on ClinicalTrials.gov

What this trial studies

This is a phase 1, single-site interventional study enrolling adults aged 18–75 with confirmed typical or variant restless legs syndrome and an IRLS score of 11 or higher. Participants will receive oral crisugabalin 40 mg twice daily for 12 consecutive weeks and attend scheduled follow-up visits to monitor symptoms and safety. The main efficacy outcome is change in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) from baseline to the end of treatment, and safety will be measured by the incidence and severity of adverse events. The protocol excludes patients with secondary RLS, significant organ dysfunction, severe CNS or psychiatric disease, or known hypersensitivity to the study drug.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with neurologist-confirmed typical or variant RLS and moderate to severe symptoms (IRLS ≥11) who can attend in-person visits and give informed consent.

Not a fit: Patients with secondary RLS causes, recent major stroke, severe cardiac, liver, or kidney disease, active serious mental illness, or known hypersensitivity to the drug are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this drug could reduce RLS symptom severity and offer a new treatment option for patients who need alternatives to existing therapies.

How similar studies have performed: Related agents that modulate similar pathways (for example pregabalin and gabapentin) have shown benefit for RLS, but crisugabalin is a novel agent and this is an early-phase test of its effects.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Capital Medical University Affiliated Beijing Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Wenlu Zhao

Conditions Restless Leg Syndrome; Variant Restless Legs Syndrome