NCT05324449 is a Phase 4 clinical trial of Cannabidiol 100 MG/ML in Anxiety, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc..

Who is sponsoring NCT05324449?

NCT05324449 is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc..

What drugs are being tested in NCT05324449?

Interventions in NCT05324449: Cannabidiol 100 MG/ML.

What condition does NCT05324449 study?

NCT05324449 studies Anxiety, Epilepsy.

Is NCT05324449 still recruiting?

NCT05324449 is currently completed. Last updated 2 July 2025.

Last reviewed 2025-07-02 · How we verify

NCT05324449

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Epidiolex® for Anxiety in Pediatric Epilepsy

Completed Phase 4 Last updated 2 July 2025

What this trial tests

Phase 4 trial testing Cannabidiol 100 MG/ML in Anxiety in 20 participants. Completed in 5 May 2025.

Timeline

5 April 2022

Primary endpoint
17 March 2025

5 May 2025

Quick facts

Lead sponsor	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	5 April 2022
Primary completion	17 March 2025
Estimated completion	5 May 2025
Sites	1 location across United States

Drugs / interventions tested

Cannabidiol 100 MG/ML — full drug profile →

Conditions studied

Anxiety — all drugs for Anxiety →
Epilepsy — all drugs for Epilepsy →

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Who can join

Adults 6 to 17, any sex, with Anxiety or Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective open label study assessing the efficacy and tolerability of pharmaceutical grade cannabidiol--Epidiolex (R), for the treatment of anxiety in pediatric patients with pediatric epilepsy that has been difficult to treat and requires ongoing use of anticonvulsant medication.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

The therapeutic potential of purified cannabidiol.
O'Sullivan SE, Jensen SS, Nikolajsen GN, Bruun HZ, et al · · 2023 · cited 33× · PMID 37312194 · DOI 10.1186/s42238-023-00186-9
Strategies to Improve Cannabidiol Bioavailability and Drug Delivery.
O'Sullivan SE, Jensen SS, Kolli AR, Nikolajsen GN, et al · · 2024 · cited 23× · PMID 38399459 · DOI 10.3390/ph17020244
FAAH Modulators from Natural Sources: A Collection of New Potential Drugs.
Nicoara C, Fezza F, Maccarrone M. · · 2025 · cited 4× · PMID 40214504 · DOI 10.3390/cells14070551
Review of the current ongoing clinical trials exploring the possible anti-anxiety effects of cannabidiol.
Bhuller R, Schlage WK, Hoeng J. · · 2024 · cited 4× · PMID 39394179 · DOI 10.1186/s42238-024-00250-y
The Current State of Unapproved Cannabidiol Product Use in Children.
Cowell B, Van de Roovaart H, Beck M, Chen AMH, et al · · 2025 · PMID 41112335 · DOI 10.5863/jppt-24-00081

Verify or expand the search:

Other trials of Cannabidiol 100 MG/ML

Trials testing the same drug.

NCT04582591 — Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy · Phase 2 · unknown

Other recruiting trials for Anxiety

Currently open trials in the same condition.

NCT07336238 — Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or · Phase 2 · recruiting
NCT07522944 — AI-Guided Relaxation for Hemodialysis Anxiety · NA · recruiting
NCT07466875 — Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients · NA · recruiting
NCT07425951 — Building Cognitive Behavioural Skills With StoryBooks to Reduce Emotional Difficulties in Kindergarten Years · NA · recruiting
NCT07473505 — Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospect · recruiting

Other Hugo W. Moser Research Institute at Kennedy Krieger, Inc. trials

Trials by the same sponsor.

NCT07221968 — Melatonin for the Treatment of DEE-SWAS · Phase 2 · not yet recruiting
NCT07061470 — A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep · Phase 1, PHASE2 · not yet recruiting
NCT06915480 — Reducing Missed Appointments · Phase 3 · recruiting
NCT07278388 — Neural Mechanisms of Fatigue in Post-Acute Sequela of SARS-CoV-2 · NA · recruiting
NCT06810180 — Examination of the Dynamic Relationships of Sleep, Physical Activity, and Circadian Rhythmicity With Neurobehavioral Het · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05324449 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Last refreshed: 2 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05324449.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing