CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Vivarin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02832336
NCT02832336Phase 2Completed

The Effect of Caffeine on the Narcoleptic Patients Randomized Controlled Clinical Trial

King Saud University·interventional·Posted Jul 14, 2016·Updated Mar 1, 2019

In Brief

A Phase 2 clinical trial evaluating Vivarin and Fiber for Narcolepsy. Completed, enrolled 16 participants across 1 site.

Detailed Summary

Caffeine may be playing a beneficial role in patients with narcolepsy. However, the relationship between caffeine and its effects on narcoleptic patients has not been examined, and it is also unclear whether caffeine provides a beneficial effect or not. Hence, the aim of this study is to assess the effects of caffeine consumption on daytime sleepiness and reaction time in narcoleptic patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy
CountriesSaudi Arabia

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 14, 2016
Enrollment StartOct 1, 2016
Primary CompletionMay 11, 2017
Study CompletionMay 7, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.0 years ago

Interventions

Vivarindrug

Adenosine is an endogenous sleep-promoting substance with neuronal inhibitory effects. Adenosine has been proposed to be a sleep-inducing substance accumulating in the brain during prolonged wakefulness. Caffeine is an adenosine receptor antagonist. It inhibits a part of the sleep cycle and, in turn, promotes the wakeup state. Caffeine results in the release of norepinephrine, dopamine and serotonin in the brain and the increase of circulating catecholamines, consistent with reversal of the inhibitory effect of adenosine.Vivarin Drug class :Central nervous system (CNS) stimulants.

Fiberdrug

Fiber will be used as placebo.