NCT05097261 (BIKe) is a Phase 4 clinical trial of Ketamine in Brain Injuries, Traumatic, sponsored by Geert Meyfroidt, MD, PhD.

Who is sponsoring NCT05097261?

NCT05097261 is sponsored by Geert Meyfroidt, MD, PhD.

What drugs are being tested in NCT05097261?

Interventions in NCT05097261: Ketamine, Placebo.

What condition does NCT05097261 study?

NCT05097261 studies Brain Injuries, Traumatic.

Is NCT05097261 still recruiting?

NCT05097261 is currently recruiting now. Last updated 22 August 2024.

Last reviewed 2024-08-22 · How we verify

NCT05097261: BIKe

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

Ketamine in Acute Brain Injury Patients.

Recruiting now Phase 4 Last updated 22 August 2024

What this trial tests

Phase 4 trial testing Ketamine in Brain Injuries, Traumatic in 100 participants. Currently enrolling.

Timeline

6 September 2021

Primary endpoint
31 December 2025

30 June 2026

Quick facts

Lead sponsor	Geert Meyfroidt, MD, PhD
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	100
Start date	6 September 2021
Primary completion	31 December 2025
Estimated completion	30 June 2026
Sites	8 locations across Belgium

Drugs / interventions tested

Ketamine (ketamine) — full drug profile →
Placebo

Conditions studied

Brain Injuries, Traumatic — all drugs for Brain Injuries, Traumatic →

Sponsor

Geert Meyfroidt, MD, PhD

Who can join

18 and older, any sex, with Brain Injuries, Traumatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Although, in the past years, an increasing use of ketamine in Traumatic Brain injury (TBI) has been reported as an adjunct to other sedatives, there is no evidence from randomized clinical trial to support this practice. The BIKe (Brain Injury and Ketamine) study is a double-blind placebo controlled randomized multicenter clinical trial to examine the safety and feasibility of using ketamine as an adjunct to a standard sedative strategy in TBI patients.

Publications & conference data

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

Current Clinical Trials in Traumatic Brain Injury.
Ahmed Z. · · 2022 · cited 23× · PMID 35624914 · DOI 10.3390/brainsci12050527
Traumatic brain injury and immunological outcomes: the double-edged killer.
Datta S, Lin F, Jones LD, Pingle SC, et al · · 2023 · cited 10× · PMID 37228857 · DOI 10.2144/fsoa-2023-0037
Brain Injury and Ketamine study (BIKe): a prospective, randomized controlled double blind clinical trial to study the effects of ketamine on therapy intensity level and intracranial pressure in severe traumatic brain injury patients.
De Sloovere V, Mebis L, Wouters P, Guïza F, et al · · 2025 · cited 5× · PMID 40437634 · DOI 10.1186/s13063-025-08835-5
Resuscitation and Initial Management After Moderate-to-Severe Traumatic Brain Injury: Questions for the On-Call Shift.
Barea-Mendoza JA, Chico-Fernández M, Ballesteros MA, Caballo Manuel A, et al · · 2024 · cited 1× · PMID 39685782 · DOI 10.3390/jcm13237325
Brain injury and ketamine study (BIKe): a prospective, randomized controlled double blind clinical trial to study the effects of ketamine on Therapy Intensity Level and intracranial pressure in severe traumatic injury patients.
De Sloovere VT, Mebis L, Wouters P, Grandas FG, et al · · 2024 · DOI 10.21203/rs.3.rs-3889642/v1
42nd International Symposium on Intensive Care & Emergency Medicine
· 2023

Verify or expand the search:

Other trials of Ketamine

Trials testing the same drug.

NCT05945147 — Ketamine and Midazolam Infusions for CRPS: Feasibility Study · Phase 2 · withdrawn
NCT06963294 — Ketamine and Dexmedetomidine for Delirium in Joint Arthroplasty · NA · not yet recruiting
NCT07294092 — Ketamine and Propofol NeuroImaging · EARLY_PHASE1 · recruiting
NCT07197684 — Ultrasound Guided Pecs Block and Ketamine Infusion for Preventing Chronic Pain in Patients Undergoing Breast Cancer Surg · NA · not yet recruiting
NCT06231563 — Ketamine for Veterans With Parkinson's Disease · Phase 2 · recruiting

Other recruiting trials for Brain Injuries, Traumatic

Currently open trials in the same condition.

NCT06898242 — Early Myofascial Manual Treatment in Subjects With Spasticity Following Acquired Brain Injury · NA · active not recruiting
NCT06413173 — Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric) · NA · recruiting
NCT06142435 — mTBI Identification and Monitoring Through Retinal Scanning · recruiting
NCT05117619 — The HOME Program for Individuals With Traumatic Brain Injury and Family Members · NA · recruiting
NCT05092295 — Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury · active not recruiting

Other Geert Meyfroidt, MD, PhD trials

Trials by the same sponsor.

NCT03574896 — Acute Kidney Injury Predictor Validation Study · completed

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 NCT05097261 (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 Geert Meyfroidt, MD, PhD
Last refreshed: 22 August 2024

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/NCT05097261.

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