Trial Outcomes & Findings for A Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults (NCT NCT00302458)

NCT ID: NCT00302458

Last Updated: 2016-02-29

Results Overview

Objective measure determined from blood samples, measured 4 hours after the dose

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 44 participants
• Primary outcome timeframe: 4 hours
• Results posted on: 2016-02-29

Participant Flow

Subjects were enrolled from 2005 to 2007 at Massachusetts General Hospital and were recruited using IRB approved postings through web and email.

Based on a comprehensive screening, subjects who did not meet eligibility criteria for the study were excluded. Others withdrew or were lost to follow-up before randomization.

Participant milestones

Measure	Healthy Volunteers Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.
Overall Study STARTED	29
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Healthy Volunteers Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.
Overall Study Lost to Follow-up	1
Overall Study Ineligible after screening	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults

Baseline characteristics by cohort

Measure	Healthy Volunteers n=29 Participants Healthy volunteers each received IR-MPH, OROS-MPH, and matched placebo (in four separate visits) in a four way crossover design.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.86 years STANDARD_DEVIATION 6.06 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 hours

Population: All subjects received each combination of medications on a separate day (total= 5 days)

Objective measure determined from blood samples, measured 4 hours after the dose

Outcome measures

Measure	Placebo- Placebo n=26 Participants Healthy volunteers received a placebo, followed by a placebo four hours later	IR-MPH + OROS MPH n=26 Participants Healthy volunteers received a dose of Immediatate Release Methylphenidate at hour 0, followed by a dose of OROS-Methylphenidate four hours later	IR-MPH +IR-MPH n=26 Participants Healthy volunteers received a dose of Immediatate Release Methylphenidate at hour 0, followed by a dose of Immediate Release Methylphenidate four hours later	OROS-MPH+OROS-MPH n=26 Participants Healthy volunteers received a dose of OROS-Methylphenidate at hour 0, followed by a dose of OROS-Methylphenidate four hours later	OROS-MPH+ IR-MPH n=26 Participants Healthy volunteers received a dose of OROS-Methylphenidate at hour 0, followed by a dose of Immediate Release Methylphenidate four hours later
Peak Plasma Concentration of d-Methylphenidate	0.00 mg/L Standard Deviation 0.00	15.06 mg/L Standard Deviation 5.0	25.34 mg/L Standard Deviation 7.3	20.34 mg/L Standard Deviation 6.4	28.79 mg/L Standard Deviation 8.3

Adverse Events

Healthy Volunteers

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Healthy Volunteers n=29 participants at risk Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.
Psychiatric disorders Anxiety	24.1% 7/29 • Number of events 12
Metabolism and nutrition disorders Appetite Loss	48.3% 14/29 • Number of events 27
Cardiac disorders Aware of heartbeat	10.3% 3/29 • Number of events 4
Musculoskeletal and connective tissue disorders Chest Pain	13.8% 4/29 • Number of events 4
Ear and labyrinth disorders Dizziness	24.1% 7/29 • Number of events 8
General disorders Dry Mouth	41.4% 12/29 • Number of events 27
General disorders Fatigue	13.8% 4/29 • Number of events 7
General disorders Flushing	13.8% 4/29 • Number of events 4
Psychiatric disorders Fogginess in head	10.3% 3/29 • Number of events 4
General disorders Headache	44.8% 13/29 • Number of events 28
Cardiac disorders Heart Racing	27.6% 8/29 • Number of events 15
Musculoskeletal and connective tissue disorders Heavy limbs	17.2% 5/29 • Number of events 6
General disorders Heavy head	13.8% 4/29 • Number of events 7
General disorders Insomnia	10.3% 3/29 • Number of events 4
Musculoskeletal and connective tissue disorders Jaw Clenching	17.2% 5/29 • Number of events 8
General disorders Jittery	44.8% 13/29 • Number of events 33
General disorders Lightheaded	27.6% 8/29 • Number of events 22
Musculoskeletal and connective tissue disorders Limb Pain	6.9% 2/29 • Number of events 2
Gastrointestinal disorders Nausea	41.4% 12/29 • Number of events 17
General disorders Restlessness	13.8% 4/29 • Number of events 5
Gastrointestinal disorders Stomach Ache	24.1% 7/29 • Number of events 10
Gastrointestinal disorders Stomach discomfort	20.7% 6/29 • Number of events 7
General disorders Sweaty	6.9% 2/29 • Number of events 4
General disorders Tingling	6.9% 2/29 • Number of events 3
General disorders Tingling in hands	6.9% 2/29 • Number of events 5
General disorders Tingling in Head	6.9% 2/29 • Number of events 2
General disorders Tired	27.6% 8/29 • Number of events 11
Psychiatric disorders Unfocused	31.0% 9/29 • Number of events 16
General disorders Head Pressure	6.9% 2/29 • Number of events 3

Additional Information

Dr. Thomas Spencer

Massachusetts General Hospital

Phone: 617-726-1731

Email: spencer@helix.mgh.harvard.edu

Results disclosure agreements

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