Clinical trial · Interventional
Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy
A Randomized, Phase II Placebo-controlled Study of the Use of Extended-release Methylphenidate or Modafinil for the Treatment of Excessive Daytime Sleepiness in Children Following Cancer Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study only randomized 1 subject and was determined not feasible by DSMB
Summary
Brief summary (as posted)
RATIONALE: Methylphenidate hydrochloride or modafinil may help reduce daytime sleepiness and improve the quality of life of patients with excessive daytime sleepiness after cancer therapy. It is not yet known whether methylphenidate hydrochloride or modafinil are more effective than a placebo in reducing daytime sleepiness in these patients. PURPOSE: This randomized phase II trial is studying methylphenidate hydrochloride or modafinil to see how well they work compared with a placebo in treating young patients with excessive daytime sleepiness after cancer therapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Tumor, Pediatric | Childhood Central Nervous System Neoplasm | ALIAS | 0.90 |
| Fatigue | — | UNRESOLVED | — |
| Specific Disorders of Sleep | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| methylphenidate hydrochloride | Drug | — | UNRESOLVED |
| modafinil | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I - methylphenidate hydrochloride
- description
- Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
- interventionNames
- Drug: methylphenidate hydrochloride
- type
- EXPERIMENTAL
- label
- Arm II -modafinil
- description
- Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
- interventionNames
- Drug: modafinil
- type
- PLACEBO_COMPARATOR
- label
- Arm III placebo
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA: * Patient and family must agree to return to the clinic up to 8 times within 2 months * Children ≥ 8 and \<18 years of age at the time of study entry who were previously treated for: * a hypothalamic tumor * mid-line brain tumor * a tumor involving one or both thalami * craniopharyngioma * diagnosis of hydrocephalus secondary to a brain tumor or treatment of a brain tumor that required placement of a permanent shunt. * Off cancer treatment for at least six months * Proficient in English * Able to swallow capsules * Experiencing symptoms of excessive daytime sleepiness (EDS) for at least three months prior to study entry that is not a result of inadequate sleep hygiene or other known medical disorder. * Negative pregnancy test EXCLUSION CRITERIA: * Patients treated with doxorubicin or high dose cyclophosphamide * History of a clinically significant drug sensitivity to methylphenidate, modafinil, armodafinil or any of their components * Known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease * Have taken methylphenidate or modafinil within the last 14 days * Current/concurrent use of antihistamines, benzodiazepine, anticonvulsants or alcohol * Clinical diagnosis of major depression, subclinical depression, or anxiety disorder * History of psychosis or mania * Patients with suicidal ideation * Diagnosis with anemia, untreated hypothyroidism, mononucleosis or narcolepsy * History of substance abuse * Pregnant or breast feeding * A total dietary intake of more than 500 mg of caffeine per day (e.g., approximately ten 330 mL cans of soft drinks, five cups of coffee or tea, or 750 g chocolate per day).
References
Publications (0)
Data not yet available