Clinical trial • Phase IV • Neurology

METHYLPHENIDATE HYDROCHLORIDE for Coma due to acute brain injury

Phase IV trial of METHYLPHENIDATE HYDROCHLORIDE for Coma due to acute brain injury.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Coma due to acute brain injury
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
17-12-2025
First CTIS Authorization Date
27-04-2026

Trial design

Randomised, placebo manufactured by the hospital pharmacy of the capital region in denmark; the placebo product does not contain active substance and is otherwise identical to the imp after preparation.-controlled Phase IV trial across 5 sites in Austria, Denmark, France and others.

Randomised
Yes
Comparator
Placebo manufactured by the hospital pharmacy of the Capital Region in Denmark; The placebo product does not contain active substance and is otherwise identical to the IMP after preparation.
Target Sample Size
324
Trial Duration For Participant
100

Eligibility

Recruits 324 Vulnerable population selected: comatose ICU patients. Informed consent is required from the legal proxy ("Informed consent from legal proxy")..

Vulnerable Population
Vulnerable population selected: comatose ICU patients. Informed consent is required from the legal proxy ("Informed consent from legal proxy").

Inclusion criteria

  • {"criterion_text":"- Adults (≥18 years) admitted to the intensive care unit (ICU) with acute traumatic or non-traumatic brain injury"}
  • {"criterion_text":"- Unresponsiveness (FOUR score ≤11, or SECONDs ≤5); no signs of consistent command-following"}
  • {"criterion_text":"- Hemodynamically stable"}
  • {"criterion_text":"- Informed consent from legal proxy"}

Exclusion criteria

  • {"criterion_text":"- Preexisting severe mental handicap"}
  • {"criterion_text":"- Active seizures or status epilepticus"}
  • {"criterion_text":"- Anticipated withdrawal of life-sustaining therapy or death within 48h"}
  • {"criterion_text":"- Hepatic or renal failure (as judged by investigator)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Time to awakening, defined as first sustained improvement in consciousness (FOUR, e = 4; or FOUR, total score ≥12; or SECONDs ≥6; confirmed on two consecutive exams 1h apart).","definition_or_measurement_approach":"Defined and measured using FOUR or SECONDs scores: first sustained improvement meeting specified score thresholds, confirmed on two consecutive examinations one hour apart."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of patients achieving clinical arousal","definition_or_measurement_approach":"Proportion measured by clinical assessment of arousal (clinical criteria as per study protocol)."}
  • {"endpoint_text":"- ICU mortality and length of stay","definition_or_measurement_approach":"Measured from ICU records: mortality during ICU stay and duration of ICU admission."}
  • {"endpoint_text":"- 3-month outcome (mRS, CPC, GOS-E)","definition_or_measurement_approach":"Measured at 3 months using standard outcome scales: modified Rankin Scale (mRS), Cerebral Performance Category (CPC), and Glasgow Outcome Scale-Extended (GOS-E)."}

Recruitment

Planned Sample Size
324
Recruitment Window Months
30
Consent Approach
Informed consent is obtained from a legal proxy ("Informed consent from legal proxy"). Subject information and informed consent forms for patients and legal representatives are provided; documents include German, French and Danish versions as indicated in submitted documentation.

Geography

Total Number Of Sites
5
Total Number Of Participants
324

Austria

Earliest CTIS Part Ii Submission Date
10-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
20
Number Of Sites
1
Number Of Participants
65

Sites

Site Name
Johannes Kepler University Linz
Department Name
Department of Neurology
Contact Person Name
Raimund Helbok

Denmark

Earliest CTIS Part Ii Submission Date
10-04-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
17
Number Of Sites
2
Number Of Participants
129

Sites

Site Name
Rigshospitalet
Department Name
Afdeling for Hjerne- og Nervesygdomme
Contact Person Name
Daniel Kondziella
Contact Person Email
daniel.kondziella@regionh.dk
Site Name
Bispebjerg Hospital
Department Name
Afdeling Z
Contact Person Name
Nanna Reiter
Contact Person Email
Nanna.Reiter@regionh.dk

France

Earliest CTIS Part Ii Submission Date
16-04-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
11
Number Of Sites
1
Number Of Participants
65

Sites

Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Department of Neurology
Contact Person Name
Benjamin Rohaut

Germany

Earliest CTIS Part Ii Submission Date
10-03-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
55
Number Of Sites
1
Number Of Participants
65

Sites

Site Name
Ludwig-Maximilians-Universitaet Muenchen
Department Name
Department of Neurology
Contact Person Name
Konstantinos Dimitriadis

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"1","organisation_type":"Health care"}

Investigational products

Investigational Product Name
METHYLPHENIDATE
Active Substance
METHYLPHENIDATE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation exists (existing product with marketing authorisation).
Maximum Dose
20 mg
Investigational Product Name
Placebo manufactured by the hospital pharmacy of the Capital Region in Denmark; The placebo product does not contain active substance and is otherwise identical to the IMP after preparation.
Modality
Other

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