Crisugabalin for restless legs and variant restless legs
Official title: Observation of Efficacy and Safety of Novel Calcium Channel Modulators in the Treatment of Restless Legs Syndrome and Its Variant Subtypes
Run by Beijing Friendship Hospital · NCT07453862 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | March 10, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | March 6, 2026 |
| Trial ID | NCT07453862 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Capital Medical University Affiliated Beijing Friendship Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Wenlu Zhao
- Email: 912977992@qq.com
- Phone: 13017688128
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.