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Tests treatment safety and results for Restless Leg Syndrome (RLS)
Official title Novel Calcium Channel Modulators in RLS and Variants: Efficacy & Safety
ClinicalTrials.gov ID: NCT07453862
What this study is testing
What is Crisugabalin?
Crisugabalin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for restless leg syndrome (rls).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 1\. Secondary RLS (e.g., iron deficiency anemia with serum ferritin \<30μg/L, renal dysfunction with eGFR \<30ml/min, pregnancy/lactation...
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.