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NCT07453862
Novel Calcium Channel Modulators in RLS and Variants: Efficacy & Safety
Phase 1 trial testing Crisugabalin in Restless Leg Syndrome (RLS) in 20 participants. Currently enrolling.
30 June 2027
Quick facts
| Lead sponsor | Beijing Friendship Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 10 March 2026 |
| Primary completion | 30 June 2027 |
| Estimated completion | 31 August 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Crisugabalin — full drug profile →
Conditions studied
- Restless Leg Syndrome (RLS) — all drugs for Restless Leg Syndrome (RLS) →
- Variant Restless Legs Syndrome — all drugs for Variant Restless Legs Syndrome →
Sponsor
Beijing Friendship Hospital
Who can join
Adults 18 to 75, any sex, with Restless Leg Syndrome (RLS) or Variant Restless Legs Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07453862
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Other recruiting trials for Restless Leg Syndrome (RLS)
Currently open trials in the same condition.
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Other Beijing Friendship Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07453862 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Friendship Hospital
- Last refreshed: 6 March 2026
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