How many clinical trials are studying Modafinil?

3 recruiting trials in our tracked data involve Modafinil.

What conditions is Modafinil being studied for?

In our tracked recruiting trials, Modafinil is being studied in trials for Cognition, Schizophrenia, Bipolar Disorder With Psychotic Features.

Modafinil: clinical trials recruiting now

Q: Is Modafinil FDA-approved?

Yes. According to the FDA drug label available through openFDA, Modafinil is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Modafinil appears in the FDA drug-label database. Marketed as Modafinil.
Drug class: Sympathomimetic-like Agent (FDA established pharmacologic class)

FDA-approved use

Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness. Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). () Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.

FDA label via openFDA

Phase breakdown

Phase 2 1 Phase 3 3

Conditions being studied

Condition	Trials
Cognition	2
Schizophrenia	2
Bipolar Disorder With Psychotic Features	1
Bipolar disorder	1
Chronic Fatigue	1
Crohn's disease	1
Depression	1
Healthy Participants	1
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)	1
Major Depressive Disorder With Psychotic Features	1
Psychosis	1
Psychosis NOS	1
Psychotic Disorder	1
Schizoaffective Disorder	1
Schizophrenia Disorder	1

Recruiting trials involving Modafinil

Cognitive Strategies in Early Psychosis 1
NCT07231497 · Phase: Phase 3 · Ages: 18 Years to 35 Years · Sex: All (male and female) · 1 location
Cognitive Strategies in Early Psychosis 2
NCT07263022 · Phase: Phase 3 · Ages: 18 Years to 35 Years · Sex: All (male and female) · 1 location
Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial)
NCT07582458 · Phase: Phase 2, Phase 3 · Ages: 18 Years to 75 Years · Sex: All (male and female) · 4 locations

Common questions

Is Modafinil FDA-approved?

Yes, marketed as Modafinil.

How many recruiting trials involve Modafinil?

3 recruiting trials across 15 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.