MedPath

Modafinil

Generic Name
Modafinil
Brand Names
Provigil
Drug Type
Small Molecule
Chemical Formula
C15H15NO2S
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
-

Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

First Posted Date
2019-03-06
Last Posted Date
2023-06-08
Lead Sponsor
Pfizer
Target Recruit Count
56
Registration Number
NCT03864042
Locations
🇨🇦

Sir Mortimer B Davis Jewish General Hospital, Montreal, Quebec, Canada

🇺🇸

UC Irvine Health, Orange, California, United States

🇺🇸

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP), Aurora, Colorado, United States

and more 26 locations

Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia

Phase 2
Completed
Conditions
Idiopathic Hypersomnia
Narcolepsy Without Cataplexy
Interventions
Drug: Modafinil
Drug: Amphetamine-Dextroamphetamine
First Posted Date
2018-12-11
Last Posted Date
2024-05-23
Lead Sponsor
Emory University
Target Recruit Count
44
Registration Number
NCT03772314
Locations
🇺🇸

Emory Sleep Center, Atlanta, Georgia, United States

Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue

Phase 4
Completed
Conditions
Multiple Sclerosis
Interventions
Behavioral: Telephone-based Cognitive Behavioral Therapy
Drug: Modafinil
First Posted Date
2018-08-08
Last Posted Date
2022-12-27
Lead Sponsor
University of Michigan
Target Recruit Count
343
Registration Number
NCT03621761
Locations
🇺🇸

The University of Washington, Seattle, Washington, United States

🇺🇸

The University of Michigan, Ann Arbor, Michigan, United States

Modafinil's Effects on Cognition in Remitted MDD

Phase 3
Terminated
Conditions
Cognitive Impairment
Major Depressive Disorder
Interventions
Drug: Placebo
Drug: Modafinil
First Posted Date
2018-08-08
Last Posted Date
2019-08-08
Lead Sponsor
Unity Health Toronto
Target Recruit Count
9
Registration Number
NCT03620253
Locations
🇨🇦

St. Michael's Hospital, Toronto, Ontario, Canada

Modafinil Effects on EEG Biomarkers of Reward and Motivation

Phase 4
Completed
Conditions
Healthy Adults
Interventions
Drug: placebo
Drug: Modafinil
First Posted Date
2018-08-06
Last Posted Date
2022-04-06
Lead Sponsor
University of California, San Diego
Target Recruit Count
23
Registration Number
NCT03616717
Locations
🇺🇸

University of California, San Diego; Clinical Teaching Facilities, Hillcrest, San Diego, California, United States

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: TAK-925
Drug: TAK-925 Placebo
Drug: Modafinil
Drug: Modafinil Placebo
First Posted Date
2018-05-11
Last Posted Date
2021-03-26
Lead Sponsor
Takeda
Target Recruit Count
20
Registration Number
NCT03522506
Locations
🇺🇸

PRA Health Sciences, Salt Lake City, Utah, United States

Touchscreen-based Cognitive Tests in Healthy Volunteers

First Posted Date
2018-03-19
Last Posted Date
2018-10-16
Lead Sponsor
University of Eastern Finland
Target Recruit Count
16
Registration Number
NCT03469089
Locations
🇫🇮

University of Eastern Finland, Clinical Research Centre, Brain Research Unit, Kuopio, Finland

Modafinil for the Treatment of Alcohol Use Disorders

Phase 2
Completed
Conditions
Alcohol Use Disorder
Interventions
Other: Placebo
Drug: Modafinil
First Posted Date
2018-02-07
Last Posted Date
2020-05-26
Lead Sponsor
The Mind Research Network
Target Recruit Count
12
Registration Number
NCT03424681
Locations
🇺🇸

Mind Research Network, Albuquerque, New Mexico, United States

Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis

Phase 3
Completed
Conditions
Fatigue in Multiple Sclerosis
Interventions
First Posted Date
2017-06-14
Last Posted Date
2020-10-20
Lead Sponsor
Johns Hopkins University
Target Recruit Count
141
Registration Number
NCT03185065
Locations
🇺🇸

University of California San Francisco, San Francisco, California, United States

🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation

Phase 1
Completed
Conditions
Sleep Deprivation
Interventions
Drug: THN102
Drug: Placebo
Drug: Modafinil
First Posted Date
2017-06-09
Last Posted Date
2017-06-09
Lead Sponsor
Theranexus
Target Recruit Count
20
Registration Number
NCT03182413
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