Modafinil

Generic Name: Modafinil

Brand Names: Provigil

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₁₅NO_₂S

CAS Number: 68693-11-8

Unique Ingredient Identifier: R3UK8X3U3D

Background: Modafinil is a stimulant drug marketed as a 'wakefulness promoting agent' and is one of the stimulants used in the treatment of narcolepsy. Narcolepsy is caused by dysfunction of a family of wakefulness-promoting and sleep-suppressing peptides, the orexins, whose neurons are activated by modafinil. The prexin neuron activation is associated with psychoactivation and euphoria. The exact mechanism of action is unclear, although in vitro studies have shown it to inhibit the reuptake of dopamine by binding to the dopamine reuptake pump, and lead to an increase in extracellular dopamine. Modafinil activates glutamatergic circuits while inhibiting GABA.

Indication: To improve wakefulness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy.

Associated Conditions: Attention Deficit Hyperactivity Disorder (ADHD), Fatigue, Major Depressive Disorder (MDD), Narcolepsy, Obstructive Sleep Apnea (OSA), Shift-work related sleep disturbance

Associated Therapies: -

Clinical Trials

Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention

Phase 2

Completed

Conditions: Cocaine-Related Disorders

Interventions: Behavioral: Acceptance and Commitment Therapy (ACT)
Behavioral: Drug Counseling (DC)
Behavioral: Contingency Management (CM)
Drug: Placebo
Drug: Modafinil

First Posted Date: 2016-09-12

Last Posted Date: 2023-02-08

Lead Sponsor: The University of Texas Health Science Center, Houston

Target Recruit Count: 118

Registration Number: NCT02896712

Locations: 🇺🇸
UTHealth Center for Neurobehavioral Research on Addiction, Houston, Texas, United States

A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients

Phase 2

Withdrawn

Conditions: Parkinson's Disease

Interventions: Drug: Duloxetine
Drug: Donepezil
Drug: Modafinil

First Posted Date: 2016-08-05

Last Posted Date: 2017-12-12

Lead Sponsor: University of Chicago

Registration Number: NCT02857244

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States

A Study of LY3154207 on Sleep in Healthy Male Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: LY3154207
Drug: Modafinil

First Posted Date: 2015-11-13

Last Posted Date: 2016-04-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 16

Registration Number: NCT02603861

Locations: 🇺🇸
Parexel Early Phase Unit at Glendale, Glendale, California, United States

Complementary Combination Therapy for Cocaine Dependence

Phase 1

Completed

Conditions: Cocaine Dependence

Interventions: Drug: Doxazosin
Drug: Modafinil
Drug: cocaine
Drug: Placebo

First Posted Date: 2015-09-02

Last Posted Date: 2022-04-26

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 45

Registration Number: NCT02538744

Locations: 🇺🇸
Michael Debakey VA Medical Center, Houston, Texas, United States

Evaluation of Modafinil vs Placebo for Treatment of Anesthesia Delayed Emergence in Obstructive Sleep Apnea

Phase 4

Terminated

Conditions: Obstructive Sleep Apnea
Delayed Emergence From Anesthesia

Interventions: Drug: Placebo
Drug: Modafinil

First Posted Date: 2015-07-10

Last Posted Date: 2019-06-20

Lead Sponsor: Milton S. Hershey Medical Center

Target Recruit Count: 105

Registration Number: NCT02494102

Locations: 🇺🇸
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States

The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study

Phase 4

Conditions: Fatigue

Interventions: Drug: Modafinil

First Posted Date: 2015-03-11

Last Posted Date: 2015-03-11

Lead Sponsor: Seoul National University Bundang Hospital

Target Recruit Count: 20

Registration Number: NCT02385656

Locations: 🇰🇷
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of

Pain Expectations in Subjects With Osteoarthritis

Phase 4

Completed

Conditions: Osteoarthritis

Interventions: Drug: Placebo
Drug: Modafinil
Drug: Gabapentin

First Posted Date: 2014-06-04

Last Posted Date: 2019-03-07

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 30

Registration Number: NCT02155257

Locations: 🇺🇸
Wake Forest School of Medicine, Winston-Salem, North Carolina, United States

Neurochemical Modulation Cognitive Performance and Subjective Wellbeing In Healthy Controls

Not Applicable

Completed

Conditions: Healthy Volunteers
Creativity
Motivation
Cognitive Performance
Reward
Subjective Pleasure

Interventions: Drug: Placebo
Drug: Modafinil

First Posted Date: 2014-01-31

Last Posted Date: 2014-01-31

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Target Recruit Count: 64

Registration Number: NCT02051153

Locations: 🇬🇧
Department of Psychiatry, Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, United Kingdom

Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill

Phase 3

Withdrawn

Conditions: Delirium
Respiratory Failure

Interventions: Drug: Placebo
Drug: Modafinil

First Posted Date: 2014-01-07

Last Posted Date: 2016-11-03

Lead Sponsor: Brigham and Women's Hospital

Registration Number: NCT02028260

Locations: 🇺🇸
Brigham & Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

Modafinil and Cognitive Function in POTS

Early Phase 1

Active, not recruiting

Conditions: Postural Tachycardia Syndrome

Interventions: Drug: Placebo
Drug: Modafinil
Drug: Propranolol

First Posted Date: 2013-11-20

Last Posted Date: 2025-01-10

Lead Sponsor: Vanderbilt University Medical Center

Target Recruit Count: 20

Registration Number: NCT01988883

Locations: 🇺🇸
Vanderbilt University, Nashville, Tennessee, United States

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