Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Brain Tumor, PediatricCancer-related FatigueMethylphenidate
Interventions
DRUG

Methylphenidate (MPH)

"10 mg methylphenidate tablets with a scoreline. Tablets will be administered orally.~For children aged 6-12, a daily dose of 5 mg x 2 will be administered during the first week with an increase in dose to 10 mg x 2 in the second week. For adolescents and adults above 12 years of age, the same starting dose will be used as for children, with weekly incremental increases up to a maximum of 15 mg x 2 daily in the third week. In case of potential toxicity events during study, dosage of methylphenidate can be modified according to protocol."

DRUG

Placebo

"10 mg methylphenidate-matched placebo tablets with a scoreline. Tablets will be administered orally.~Dosage will follow the exact same principles as for the study drug (methylphenidate)."

Trial Locations (4)

2100

Rigshospitalet, Copenhagen

5000

Odense University Hospital, Odense

8200

Aarhus University Hospital, Aarhus

9000

Aalborg University Hospital, Aalborg

All Listed Sponsors
collaborator

Aarhus University Hospital Skejby

OTHER

collaborator

Aalborg University Hospital

OTHER

collaborator

Rigshospitalet, Denmark

OTHER

collaborator

University of Southern Denmark

OTHER

lead

Odense University Hospital

OTHER