Phase 4 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 55 years of age or older
- You have been diagnosed by a doctor with Alzheimer's-type dementia, ranging from very mild to severe
- You show signs of agitation or restlessness at nighttime, based on a specific assessment tool used by the study team
- Your doctor agrees that medication to help with agitation would be appropriate for you
- You have been assessed by the study nurses and found to show signs of Restless Legs Syndrome (an uncomfortable urge to move the legs, often worse at night)
- Your overall health is stable — meaning your medications have not changed in the last 14 days and you do not have any signs of a new illness like a urinary tract infection or fever
- You are able to swallow pills or tablets
- You are able to walk, even if you need some help to do so
- If you are already being treated for Restless Legs Syndrome but still have symptoms, you may still be considered (confirm with trial site)
Who may not be able to join:
- You are currently taking high doses of opioid pain medications (above a certain daily limit set by the study)
- You are already being treated for Restless Legs Syndrome using gabapentin or gabapentin enacarbil (the study drug)
- You have been diagnosed with Parkinson's disease or another condition that causes tremors
- You are currently taking gabapentin for any reason
- You have severe psychosis (serious difficulties with thinking or perception of reality)
- You drink alcohol regularly, as combining it with the study drug can cause increased drowsiness and other problems
- The study drug is medically unsuitable for you — for example, if you are already taking several epilepsy medications (confirm with trial site)
- You have tried gabapentin or the study drug before and it did not work for you
- Your kidneys are not working well enough, based on a specific blood test measurement, or you are on kidney dialysis
- You are already taking part in another clinical trial or study that could affect the results
- The study nurses or your doctor have concerns that you may be at risk of harming yourself
- Any other medical reason that the study team believes makes it unsafe for you to join (confirm with trial site)
- You live alone in the community without a caregiver (family member or paid carer) living with you
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
Principal Investigator: Kathy Richards, PhD, The University of Texas at Austin
Phone: 7039463725
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
Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Direct Observation
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.