Trial Outcomes & Findings for Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy (NCT NCT01348607)

NCT ID: NCT01348607

Last Updated: 2014-02-21

Results Overview

Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 29 days
• Results posted on: 2014-02-21

Participant Flow

Participant milestones

Measure	Arm I - Methylphenidate Hydrochloride Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.	Arm II -Modafinil Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.	Arm III Placebo Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
Overall Study STARTED	1	0	0
Overall Study COMPLETED	1	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy

Baseline characteristics by cohort

Measure	Arm I - Methylphenidate Hydrochloride n=1 Participants Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.	Arm II -Modafinil Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.	Arm III Placebo Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	1 participants n=5 Participants	—	—	1 participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 participants n=5 Participants	—	—	0 participants n=4 Participants
Age, Categorical >=65 years	0 participants n=5 Participants	—	—	0 participants n=4 Participants
Age, Continuous	13.9 years n=5 Participants	—	—	13.9 years n=4 Participants
Gender Female	0 participants n=5 Participants	—	—	0 participants n=4 Participants
Gender Male	1 participants n=5 Participants	—	—	1 participants n=4 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	—	1 participants n=4 Participants

PRIMARY outcome

Timeframe: 29 days

Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries

Outcome measures

Measure	Arm I - Methylphenidate Hydrochloride n=1 Participants Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.	Arm II -Modafinil Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.	Arm III Placebo Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
Average Daytime Napping Minutes in a Week	36.7 minutes	—	—

SECONDARY outcome

Timeframe: 29 days

Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver.

Outcome measures

Measure	Arm I - Methylphenidate Hydrochloride n=1 Participants Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.	Arm II -Modafinil Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.	Arm III Placebo Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
Adverse Events	1 events	—	—

Adverse Events

Arm I - Methylphenidate Hydrochloride

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm II -Modafinil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm III Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm I - Methylphenidate Hydrochloride n=1 participants at risk Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.	Arm II -Modafinil Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.	Arm III Placebo Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
Gastrointestinal disorders decreased appetite	100.0% 1/1 • Number of events 1 • 1 month Complete and frequent monitoring for adverse events (AEs) were incorporated using the Systematic Assessment for Treatment Emergent Effects (SAFTEE),developed by the National Institute of Mental Health. AEs will also be assessed by weekly physical exam, review of patient/caregiver daily sleep and medicine logs and patient/caregiver interview.	— 0/0 • 1 month Complete and frequent monitoring for adverse events (AEs) were incorporated using the Systematic Assessment for Treatment Emergent Effects (SAFTEE),developed by the National Institute of Mental Health. AEs will also be assessed by weekly physical exam, review of patient/caregiver daily sleep and medicine logs and patient/caregiver interview.	— 0/0 • 1 month Complete and frequent monitoring for adverse events (AEs) were incorporated using the Systematic Assessment for Treatment Emergent Effects (SAFTEE),developed by the National Institute of Mental Health. AEs will also be assessed by weekly physical exam, review of patient/caregiver daily sleep and medicine logs and patient/caregiver interview.

Additional Information

Cristina Burroughs, Clinical Research Administrator

SunCoast CCOP Research Base

Phone: (813) 396-9237

Email: Cristina.Burroughs@epi.usf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place