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NCT03082755 · ClinicalTrials.gov registry record · Phase 4
Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
A Phase 4 study of Alzheimer Disease, sponsored by University of Texas at Austin.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 156
- Enrollment target
- 1
- Study location
NCT03082755 is a Phase 4 study of Alzheimer Disease that is actively recruiting participants, run by University of Texas at Austin. The registered enrollment target is 156 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03082755, a Phase 4 study of Alzheimer Disease, is actively recruiting participants, sponsored by University of Texas at Austin.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 156 participants
- Enrollment target
- 1
- Study location
Study Summary
Nighttime agitation in persons with Alzheimer's disease causes patient suffering, distresses caregivers, and often results in prescriptions for harmful antipsychotics. Effective treatments are lacking because of limited knowledge of the etiology of nighttime agitation. The investigators propose a clinical trial to better elucidate whether a sleep disorder, restless legs syndrome, may be a mechanism for nighttime agitation, and if treatment with gabapentin enacarbil (Horizant®) reduces nighttime agitation, improves sleep, reduces restless legs syndrome behaviors, and reduces antipsychotic medications.
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG Gabapentin Enacarbil
Study Locations (1)
Texas
- The University of Texas at Austin - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03082755
The ClinicalTrials.gov registry entry for NCT03082755 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (94% lower). The listed sponsor is University of Texas at Austin, which has 257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03082755 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03082755 about?
NCT03082755 is a clinical study titled "Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease". Nighttime agitation in persons with Alzheimer's disease causes patient suffering, distresses caregivers, and often results in prescriptions for harmful antipsychotics. Effective treatments are lacking because of limited knowledge of the etiology of nighttime agitation. The investigators propose a cl...
What is the current status of trial NCT03082755?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 156 participants. The study started on 2017-07-01. Estimated completion is 2023-03-31.
What conditions does trial NCT03082755 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT03082755?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Gabapentin Enacarbil (DRUG).
Who is sponsoring clinical trial NCT03082755?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03082755 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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