Methylphenidate for Early Awakening in Coma (MEAWAKE)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524937-19-00

Enrollment

194

Registered

2026-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coma due to acute brain injury

Brief summary

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).

Detailed description

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

Interventions

DRUGMETHYLPHENIDATE

DRUGPlacebo 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

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

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

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 28, 2026