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Compound · clinical trials

Modafinil clinical trials

Also listed in trial records as Provigil
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 2 trials in our Netherlands and Canada registers that name Modafinil as an intervention. Synced 27 Sep 2026
2Current trials
2Recruiting now
2Lead sponsors
2Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Modafinil is named as an intervention in 2 current clinical trials in our Netherlands and Canada registers. 2 are recruiting patients now. The most common phase is Phase 2/3. The sponsor with the most trials is Radboud University Medical Center (1). The most-studied condition is Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis).

Where Modafinil is approved

All regulators →

Modafinil was first approved in the US on 24 Dec 1998. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
24 Dec 1998
Provigil
NDA020717 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
26 Feb 1999
Alertec
Notice of Compliance 1933
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Trials by status

  • Recruiting2100%

Trials by phase

  • Phase 2/3150%
  • Phase 1/2150%
01

Clinical trials of Modafinil

2 trials
StudyPhaseStatusLead sponsorRegisters
Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial)
NCT07582458 · ClinicalTrials.gov ↗ · Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Chronic Fatigue
Phase 2/3 Recruiting Radboud University Medical Center Netherlands
Modafinil to Improve Fatiguability
NCT05333250 · ClinicalTrials.gov ↗ · Cancer-related Cognitive Difficulties, Cancer-related Problem/Condition, Fatigue
Phase 1/2 Recruiting Ottawa Hospital Research Institute Canada

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Modafinil across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

6 single-substance products containing Modafinil on the HPRA medicines list.

All 6 Irish products →

Supply shortages

No entry for Modafinil in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Modafinil

5 conditions
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)1Chronic Fatigue1Cancer-related Cognitive Difficulties1Cancer-related Problem/Condition1Fatigue1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Radboud University Medical Center1
Ottawa Hospital Research Institute1
05

By country register

RegisterTrialsRecruiting
Clinical trials in Netherlands11
Clinical trials in Canada11

A trial with sites in more than one country appears in each of those registers.

06

Questions about Modafinil trials

How many clinical trials are testing Modafinil?

2 current trials in our Netherlands and Canada registers name Modafinil as a drug or biological intervention, as of the registry sync on 27 September 2026. Completed and withdrawn studies are not counted.

Are Modafinil trials recruiting patients?

Yes. 2 of the 2 trials are recruiting: 1 with sites in Netherlands and 1 with sites in Canada. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Modafinil clinical trials?

Radboud University Medical Center (1) and Ottawa Hospital Research Institute (1). The number in brackets is how many trials each organisation leads.

Is Modafinil licensed in Ireland?

Yes. The HPRA medicines list includes 6 single-substance products containing Modafinil, for example Modafinil Bluefish 100 mg tablets (Bluefish Pharmaceuticals AB). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Modafinil shortage?

Not in the lists we track: Modafinil has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Modafinil works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Modafinil works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Modafinil (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 27 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.