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Clinical Trials in the EU / 2025-524937-19-00
Authorised Phase II

Methylphenidate for Early Awakening in Coma (MEAWAKE)

2025-524937-19-00 · tracked via the Priya Life Science EU tracker
Sponsor
Rigshospitalet
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Nervous System Diseases
Decision date
27/04/2026
Enrollment target
324
Sites
Austria, Denmark, Germany, France

Condition studied

Coma due to acute brain injury

Investigational medicinal product(s)

METHYLPHENIDATEPlacebo 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.

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

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).

Endpoint detail

Proportion of patients achieving clinical arousal, ICU mortality and length of stay, 3-month outcome (mRS, CPC, GOS-E)

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524937-19-00 on CTIS ↗ ← All trials in the EU