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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: Completed Phase 2 study of Epilepsy and SUDEP, sponsored by Rup Kamal Sainju.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants enrolled every 3 months.
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 |
What the finished NCT02929667 record still lists
NCT02929667 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02929667's enrollment target sits among peer trials
30 109th of 160 higher than 41 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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