Phase 1 Restless Legs Syndrome Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 18 and 75 years old (any gender).
- You have been diagnosed with Restless Legs Syndrome (RLS) by a neurologist, either the typical form or a variant, using standard international diagnostic guidelines.
- Your RLS symptoms are rated as moderate to severe, based on a standard symptom scoring scale (a score of 11 or higher on the IRLS scale).
- You are able to understand and follow the study instructions, and you are willing to sign a consent form agreeing to participate.
Who may not be able to join:
- Your RLS is caused by another underlying condition, such as low iron levels, poor kidney function, pregnancy or breastfeeding, or a medication that cannot be changed.
- You have a serious brain or nervous system condition, such as uncontrolled seizures, severe dementia, or a stroke that happened within the last 3 months.
- You have a serious heart or blood pressure condition, such as heart failure or very high blood pressure that is not controlled.
- You have severely reduced liver or kidney function, based on blood test results (confirm with trial site).
- You currently have an active mental health condition such as schizophrenia or acute bipolar disorder.
- You have a known allergy or sensitivity to the study drug (Keligabalin Benzenesulfonic Acid) or any of its ingredients.
- You have taken part in another clinical trial within the past month, are unable to attend follow-up visits, or have a history of substance abuse.
- You are currently pregnant or breastfeeding.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: 13017688128
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12; Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.