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

Acute Effect of Three Neuroactive Drugs Measured by Magnetoencephalography (MEG), Electroencephalography (EEG) and the Synchronous Neural Interaction Test

Not Applicable

Completed

Conditions: Healthy

Interventions: Drug: placebo
Drug: modafinil
Drug: methylphenidate
Drug: lorazepam

First Posted Date: 2009-09-09

Last Posted Date: 2010-01-13

Lead Sponsor: Orasi Medical, Inc.

Target Recruit Count: 15

Registration Number: NCT00972985

Locations: 🇺🇸
Alexian Brothers Neuroscience Institute, Elk Grove Village, Illinois, United States

Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC)

Phase 1

Completed

Conditions: Fatigue
Primary Biliary Cirrhosis

Interventions: Drug: Modafinil

First Posted Date: 2009-07-22

Last Posted Date: 2012-01-18

Lead Sponsor: Mayo Clinic

Target Recruit Count: 40

Registration Number: NCT00943176

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)

Phase 3

Completed

Conditions: Prostatic Neoplasms
Breast Cancer

Interventions: Drug: DOCETAXEL(XRP6976) + MODAFINIL
Drug: Modafinil
Drug: Placebo of Modafinil

First Posted Date: 2009-06-10

Last Posted Date: 2012-09-26

Lead Sponsor: Sanofi

Target Recruit Count: 84

Registration Number: NCT00917748

Locations: 🇦🇺
Sanofi-Aventis Administrative Office, Macquarie Park, Australia

Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies

Not Applicable

Completed

Conditions: Narcolepsy
Hypersomnia

Interventions: Drug: Modafinil
Drug: Placebo

First Posted Date: 2009-06-09

Last Posted Date: 2013-04-25

Lead Sponsor: University Hospital, Bordeaux

Target Recruit Count: 27

Registration Number: NCT00916253

Locations: 🇫🇷
AP-HP - Hôpital de l'Hôtel-Dieu, Paris, France
🇫🇷
GENNPHASS - CHU de Bordeaux, Bordeaux, France

The Effects of Modafinil to Counteract the Adverse Metabolic Consequences of Sleep Restriction

Not Applicable

Completed

Conditions: Sleep Restriction
Impaired Glucose Metabolism

Interventions: Drug: placebo
Drug: modafinil

First Posted Date: 2009-05-08

Last Posted Date: 2009-05-08

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 20

Registration Number: NCT00895570

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

Modafinil for Methamphetamine Dependence

Phase 2

Terminated

Conditions: Methamphetamine Dependence

Interventions: Drug: Placebo
Drug: Modafinil

First Posted Date: 2009-03-11

Last Posted Date: 2017-11-21

Lead Sponsor: University of Arkansas

Target Recruit Count: 9

Registration Number: NCT00859573

Locations: 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Pharmacotherapy & CM for Opioid and Cocaine Dependence

Phase 1

Completed

Conditions: Cocaine Dependence

Interventions: Drug: Sugar Pill
Drug: Modafinil
Behavioral: Contingency Management
Drug: Methadone
Behavioral: cognitive behavioral treatment
Behavioral: Voucher Control

First Posted Date: 2009-02-09

Last Posted Date: 2021-12-03

Lead Sponsor: Yale University

Target Recruit Count: 91

Registration Number: NCT00838981

Locations: 🇺🇸
Department of Veterans Affairs, West Haven, Connecticut, United States

Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

Phase 2

Withdrawn

Conditions: Schizophrenia

Interventions: Drug: modafinil

First Posted Date: 2009-02-06

Last Posted Date: 2020-10-14

Lead Sponsor: Manhattan Psychiatric Center

Registration Number: NCT00838227

Modafinil for the Treatment of Fatigue in Lung Cancer V9.0

Phase 4

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Placebo
Drug: Modafinil

First Posted Date: 2009-01-27

Last Posted Date: 2013-08-19

Lead Sponsor: University of Oxford

Target Recruit Count: 208

Registration Number: NCT00829322

Locations: 🇬🇧
Stoke Mandeville Hospital, Aylesbury, United Kingdom
🇬🇧
Great Western Hospital, Swindon, United Kingdom
🇬🇧
Christie Hospital, Manchester, United Kingdom

and more 21 locations

Effects of Modafinil in Methamphetamine Dependence

Phase 4

Completed

Conditions: Methamphetamine Dependence

Interventions: Drug: Placebo
Drug: Modafinil

First Posted Date: 2008-09-11

Last Posted Date: 2019-06-13

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 40

Registration Number: NCT00751023

Locations: 🇺🇸
Behavioral Health Services of Pickens County, Pickens, South Carolina, United States

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