NCT04597450

Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)

Completed Phase 1 Last updated 24 March 2023

What this trial tests

Phase 1 trial testing Lu AG06466 in PTSD in 35 participants. Completed in 13 February 2023.

Timeline

30 September 2020

Primary endpoint
13 February 2023

13 February 2023

Quick facts

Lead sponsor	H. Lundbeck A/S
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	35
Start date	30 September 2020
Primary completion	13 February 2023
Estimated completion	13 February 2023
Sites	1 location across United States

Drugs / interventions tested

• Lu AG06466 — full drug profile →
• Placebo

Conditions studied

• PTSD — all drugs for PTSD →

Sponsor

H. Lundbeck A/S — full company profile →

Who can join

Adults 18 to 55, any sex, with PTSD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to investigate the effect of Lu AG06466 after multiple doses of 30 milligrams (mg) in participants with PTSD.

Publications & conference data

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

1. Goods and Bads of the Endocannabinoid System as a Therapeutic Target: Lessons Learned after 30 Years.
   Maccarrone M, Di Marzo V, Gertsch J, Grether U, et al · · 2023 · cited 128× · PMID 37164640 · DOI 10.1124/pharmrev.122.000600
2. Targeting the Endocannabinoid System in the Treatment of Posttraumatic Stress Disorder: A Promising Case of Preclinical-Clinical Translation?
   Mayo LM, Rabinak CA, Hill MN, Heilig M. · · 2022 · cited 69× · PMID 34598785 · DOI 10.1016/j.biopsych.2021.07.019
3. Alleviating anxiety and taming trauma: Novel pharmacotherapeutics for anxiety disorders and posttraumatic stress disorder.
   Singewald N, Sartori SB, Reif A, Holmes A. · · 2023 · cited 40× · PMID 36623804 · DOI 10.1016/j.neuropharm.2023.109418