This trial is to study whether a sleep disorder, restless legs syndrome, may be a mechanism for nighttime agitation in Alzheimer's patients, and if treatment with gabapentin enacarbil (Horizant®) reduces nighttime agitation, improves sleep, reduces restless legs syndrome behaviors, and reduces antipsychotic medications.
- Alzheimer's Disease
1 Primary · 5 Secondary · Reporting Duration: Change from baseline at 2 and 8 weeks
Awards & Highlights
2 Treatment Groups
Gabapentin Enacarbil (GEn)
1 of 2
1 of 2
156 Total Participants · 2 Treatment Groups
Primary Treatment: Gabapentin Enacarbil · Has Placebo Group · Phase 4
Who is running the clinical trial?
Age 18+ · All Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
|The University of Texas at Austin||100.0%|
What portion of applicants met pre-screening criteria?
|Did not meet criteria||100.0%|
- Richards, Kathy, Janet Morrison, Yan-yan Wang, Angelica Rangel, Ana Loera, Alexandra Hanlon, Alicia Lozano, et al.. 2020. “Nighttime Agitation and Restless Legs Syndrome in Persons with Alzheimer's Disease: Study Protocol for a Double-blind, Placebo-controlled, Randomized Trial (nightrest)”. Research in Gerontological Nursing. SLACK, Inc.. doi:10.3928/19404921-20200918-01.
- 2017. "Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03082755.
Frequently Asked Questions
Are there any negative side effects to Gabapentin Enacarbil?
"Since this is a Phase 4 trial, meaning Gabapentin Enacarbil is an approved treatment, we estimate its safety to be a 3." - Anonymous Online Contributor
Are there other examples of Gabapentin Enacarbil's medical efficacy?
"Currently, there are three clinical trials underway for the use of gabapentin enacarbil. None of these trials are in phase three. However, there are many studies based in Austin, Texas. In total, 24 locations are running trials for this treatment." - Anonymous Online Contributor
Does this type of testing happen often?
"Research into Gabapentin Enacarbil began in 2016 with a study sponsored by XenoPort, Inc. This initial Phase 1 trial involved 144 people. After this first study in 2016, Gabapentin Enacarbil was approved for Phase 4 drugs. Currently, there are 3 ongoing trials across 14 cities and 1 country." - Anonymous Online Contributor