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NCT03772314 · ClinicalTrials.gov registry record · Phase 2
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
A Phase 2 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT03772314 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 44 participants.
The verdict
NCT03772314, a Phase 2 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
For diseases that cause excessive daytime sleepiness (such as narcolepsy and idiopathic hypersomnia), there are several medications that can be used to treat sleepiness. However, it can be difficult to decide which medication to use for a particular individual for several reasons: 1) there are very few studies that directly compare two medications to see which works best; 2) there are very few studies that include people with a disorder of sleepiness called idiopathic hypersomnia. To address this gap in knowledge, the researchers propose a randomized clinical trial comparing modafinil and amphetamine salts in patients with narcolepsy type 2 or idiopathic hypersomnia. All participants will either receive modafinil or amphetamine salts - no participant will receive placebo. This study will evaluate which medication works better to improve sleepiness. The researchers will also see which medication is better for other symptoms including difficulty waking up and difficulty thinking, as well as seeing which medication causes fewer side effects. Finally, this study will see if any information about patients (such as age or sleep study features) predicts responding better to one medication or the other.
Interventions
- DRUG Modafinil
- DRUG Amphetamine-Dextroamphetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2023-05-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03772314
The ClinicalTrials.gov registry entry for NCT03772314 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Modafinil is the first listed.
NCT03772314 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03772314 about?
NCT03772314 is a clinical study titled "Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia". For diseases that cause excessive daytime sleepiness (such as narcolepsy and idiopathic hypersomnia), there are several medications that can be used to treat sleepiness. However, it can be difficult to decide which medication to use for a particular individual for several reasons: 1) there are very ...
What is the current status of trial NCT03772314?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2019-04-15. Estimated completion is 2023-05-04.
What interventions are being tested in trial NCT03772314?
The interventions under investigation include: Modafinil (DRUG), Amphetamine-Dextroamphetamine (DRUG).
Who is sponsoring clinical trial NCT03772314?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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