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NCT02929667 · ClinicalTrials.gov registry record · Phase 2
Abnormal Ventilatory Response to Carbon Dioxide: a Potential Biomarker for Seizure Induced Respiratory Depression & Modification by SSRI
A Phase 2 study of Epilepsy and SUDEP, sponsored by Rup Kamal Sainju.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT02929667 is a Phase 2 study of Epilepsy and SUDEP that has completed, run by Rup Kamal Sainju. The registered enrollment target is 30 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT02929667, a Phase 2 study of Epilepsy and SUDEP, has completed, sponsored by Rup Kamal Sainju.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
Sudden unexpected death in epilepsy patients (SUDEP) is devastating outcome for some patients with epilepsy. It ranks second only to stroke among neurological diseases in years of potential life lost. Patho-mechanisms of SUDEP remain not well understood, however peri-ictal respiratory dysfunction likely plays an important role in many cases. Literature supports a critical role for the serotonergic system in central control of ventilation. Serotonin neurons in the raphe nuclei of the brainstem sense rising carbon dioxide and low pH, thereby stimulating breathing and arousal. These responses may serve as mechanisms that protect against asphyxia, particularly during sleep or the post-ictal state. In mouse models of seizure-induced sudden death, pre-treatment with selective serotonin reuptake inhibitor (SSRI) agents prevents death following seizures. Hence, the investigators hypothesize that a subset of drug resistant epilepsy patients who have impaired central chemo-responsiveness have a greater degree of peri-ictal respiratory depression, therefore a higher risk of SUDEP. The investigators further hypothesize that fluoxetine will improve central chemo-responsiveness and therefore will reduce peri-ictal respiratory depression.
Interventions
- DRUG Placebo
- DRUG Fluoxetine
Study Locations (2)
Iowa
- The Univeristy of Iowa Hospitals and Clinics - Iowa City
- Univeristy of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-02-16 |
| Est. Completion | 2019-03-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02929667
The ClinicalTrials.gov registry entry for NCT02929667 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The listed sponsor is Rup Kamal Sainju, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02929667 reports 2 study locations spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT02929667 about?
NCT02929667 is a clinical study titled "Abnormal Ventilatory Response to Carbon Dioxide: a Potential Biomarker for Seizure Induced Respiratory Depression & Modification by SSRI". Sudden unexpected death in epilepsy patients (SUDEP) is devastating outcome for some patients with epilepsy. It ranks second only to stroke among neurological diseases in years of potential life lost. Patho-mechanisms of SUDEP remain not well understood, however peri-ictal respiratory dysfunction li...
What is the current status of trial NCT02929667?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2017-02-16. Estimated completion is 2019-03-06.
What conditions does trial NCT02929667 study?
This clinical trial studies the following conditions: Epilepsy, SUDEP.
What interventions are being tested in trial NCT02929667?
The interventions under investigation include: Placebo (DRUG), Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT02929667?
This trial is sponsored by Rup Kamal Sainju, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02929667 being conducted?
This trial has 2 study locations across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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