Attention Deficit Hyperactivity DisorderNCT02536105

PK/PD Pediatric ADHD Classroom Study

A study testing Methylphenidate HCl ER tablets 1, Methylphenidate HCl ER tablets 2 and Methylphenidate HCl ER for suspension in people with Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the association between blood drug levels and the corresponding scores of commonly used behavioral instruments based upon data collected following administration of three different methylphenidate hydrochloride extended-release drug products in children with ADHD. Read more about this study

Who is it for?: Ages 6 to 12 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder
What is being tested?: Methylphenidate HCl ER tablets 1, Methylphenidate HCl ER tablets 2 and Methylphenidate HCl ER for suspension
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 88 participants
Where: 2 sitesUnited States
Study dates: May 2016to Jul 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male and female outpatients
Ages 6-12 years at time of screening
Judged by the investigator to be physically healthy and suitable for participation in the study
Diagnosis of DSM-5ADHD combined, predominantly inattentive or hyperactive/impulsive presentation, per clinical evaluation and confirmed by the MINI-KID
Clinical Global Impressions-Severity (CGI-S) ≥ 3
≥ 90th percentile normative value for gender and age on the ADHD RS-IV total score at screening or baseline

Show all 11Show fewer

Study participant has a parent/legal guardian who is willing and able to give written informed consent for him/her to participate in the study
Study participant must be able to give assent to participate in the trial
Study participant and legal guardian must be able to speak and understand English
Able to tolerate multiple finger pricks
Willing to comply with all study procedures

Who cannot join

Current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, oppositional defiant disorder, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Participants with school phobia or separation anxiety will not be eligible
Cognitively impaired, in the investigator's opinion
Any clinically significant chronic medical condition that, in the judgment of the investigator, may interfere with the participant's ability to participate in the study
Seizure disorder excluding a history of febrile seizures
Thyroid disease
Tourette's disorder or chronic tic disorder (mild medication induced tics are allowed)

Show all 19Show fewer

Serious cardiac condition including cardiomyopathy, serious arrhythmias, structural cardiac disorders, or severe hypertension
Glaucoma
Current or recent (within the past 6 months) DSM-5 drug dependence or substance abuse (excluding nicotine and caffeine)
Pregnant or nursing females. Females must have a negative urine pregnancy test at screening as well as four additional visits and must be abstinent or use adequate and reliable contraception throughout the study
Currently treated and satisfied with ADHD medication
Current psychotropic medications other than sedative hypnotics for sleep
Use of atomoxetine, clonidine, guanfacine or a monoamine oxidase inhibitor within 28 days of the baseline visit
Participation in another investigational medication study within 30 days prior to screening
Clinically significant abnormal laboratory result, electrocardiogram (ECG) result, physical examination, or vital signs at screening that the investigator considers to be inappropriate to allow participation in the study
Planned use of prohibited drugs from the baseline visit through the end of the trial
History of allergic reaction or a known or suspected sensitivity to any substance that is contained in the study drugs
Food allergies that are determined by the PI as too severe to be easily accommodated for during the study
Inability to swallow study medication

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128

Other trials in United States

About this study

Official title: Pharmacokinetic Pharmacodynamic Studies of Methylphenidate Extended Release Products in Pediatric Attention Deficit Hyperactivity Disorder

Read the detailed description

This is a randomized, double-blind, 4-treatment and 4-period crossover study conducted in a school laboratory environment to evaluate the hour-by-hour behavioral instrument scores and hour-by-hour PK of 3 different extended-release MPH formulations as well as placebo in children with ADHD. The complete study consists of three periods: Screening, Dose Titration and Double-Blind Crossover in a Laboratory Classroom.

The double-blind phase will consist of four periods (or four weeks): each week will consist of blinded administration with one of the three active methylphenidate hydrochloride treatments or placebo from Sunday through Saturday. On the last day of each period (Saturday), study participants will be evaluated in a laboratory classroom setting. On Saturdays, the blinded doses of each study drug will be administered at the school site by study staff on the morning of the test laboratory classroom day. On the other days, the medication will be taken in the morning at home.

Conditions: Attention Deficit Hyperactivity Disorder
Being tested: Methylphenidate HCl ER tablets 1, Placebo, Methylphenidate HCl ER tablets 2, Methylphenidate HCl ER for suspension
Keywords: Attention Deficit Hyperactivity Disorder, ADHD
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Methylphenidate HCl ER tablets 1Drug
PlaceboDrug
Methylphenidate HCl ER tablets 2Drug
Methylphenidate HCl ER for suspensionDrug

Study groups in NCT02536105
Study group	Role	What they receive
Methylphenidate HCl ER tablets 1	Active comparator	During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase Receives: Drug: Methylphenidate HCl ER tablets 1
Placebo	Placebo comparator	During the double-blind period, in one of the 4 study weeks, the study participant will take a blinded placebo instead of one of the the 3 active comparators. Receives: Drug: Placebo
Methylphenidate HCl ER tablets 2	Active comparator	During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase Receives: Drug: Methylphenidate HCl ER tablets 2
Methylphenidate HCl ER for suspension	Active comparator	During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase Receives: Drug: Methylphenidate HCl ER for suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products
The Permanent Product Measure of Performance (PERMP) involves objective individualized mathematics tests. Scores will be obtained ten times on each classroom day at pre-dose, and at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose. PERMP Attempted is reported here. Scale ranges 0 math questions answered to 400 math questions answered. The more number of questions answered (better score), the higher the PERMP Attempted score is.
Measured: 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day
Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products
The Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) scale is a validated, 13-item rating of subjective impairment of classroom behaviors (0 = normal/no impairment; 1 = slight impairment; 2 = mild impairment; 3 = moderate impairment; 4 = severe impairment; 5 = very severe impairment; 6 = maximal impairment). The SKAMP consists of four subscales: SKAMP-Attention, SKAMP-Deportment, SKAMP-Quality of Work, and SKAMP-Compliance, in addition to SKAMP-Total (reported here). SKAMP-Total is a sum of the four sub-scales and has a range of 0-78. The higher the score, the higher the impairment. Scores will be obtained during each classroom cycle during each full laboratory classroom day at pre-dose, and at 0.5, 1.5, 2.5, 4, 5, 6, 8, 10, and 12 hours post-dose. The scores will be based on the child's behavior during 20 minutes of each cycle.
Measured: 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day
Maximum Drug Concentration Observed (Cmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products
PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Cmax will be measured. The objectives of this measure is to estimate PK metrics, including Cmax, appropriate for characterizing rate and extent of absorption in each phase of the drug release and the evaluate the disposition and eliminating processes for each medication studied. The minimum value is pg/mL and there is was no maximum defined prior to the interventions.
Measured: 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day
Time to Reach Cmax (Tmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products
PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Tmax will be measured
Measured: 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016Jul 2018

First posted31 Aug 2015 (estimated)
Study startMay 2016
Primary completionJul 2018
Study completionJul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02536105
Sponsor's protocol ID: 2015P001113
Other IDs: 5U01FD005240
Status last verified: Nov 2019
First submitted: 24 Aug 2015
Last updated: 10 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Attention Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic Pharmacodynamic Studies of Methylphenidate Extended Release Products in Pediatric Attention Deficit Hyperactivity Disorder
ClinicalTrials.gov ID: NCT02536105
Acronym / sponsor ID: 2015P001113
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder, ADHD
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Food and Drug Administration (FDA), Center for Psychiatry And Behavioral Medicine Inc.
Study start: May 2016 (actual)
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 31 Aug 2015 (estimated)
Results: Posted 10 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Methylphenidate HCl ER tablets 1	Active comparator	Drug: Methylphenidate HCl ER tablets 1During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase
Placebo	Placebo comparator	Drug: PlaceboDuring the double-blind period, in one of the 4 study weeks, the study participant will take a blinded placebo instead of one of the the 3 active comparators.
Methylphenidate HCl ER tablets 2	Active comparator	Drug: Methylphenidate HCl ER tablets 2During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase
Methylphenidate HCl ER for suspension	Active comparator	Drug: Methylphenidate HCl ER for suspensionDuring the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (11 listed)

Male and female outpatients
Ages 6-12 years at time of screening
Judged by the investigator to be physically healthy and suitable for participation in the study
Diagnosis of DSM-5ADHD combined, predominantly inattentive or hyperactive/impulsive presentation, per clinical evaluation and confirmed by the MINI-KID
Clinical Global Impressions-Severity (CGI-S) ≥ 3

Key exclusion criteria (19 listed)

Current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, oppositional defiant disorder, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Participants with school phobia or separation anxiety will not be eligible
Cognitively impaired, in the investigator's opinion
Any clinically significant chronic medical condition that, in the judgment of the investigator, may interfere with the participant's ability to participate in the study
Seizure disorder excluding a history of febrile seizures
Thyroid disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Methylphenidate HCl ER tablets 1	Drug	Methylphenidate HCl ER tablets 1
Placebo	Drug	Placebo
Methylphenidate HCl ER tablets 2	Drug	Methylphenidate HCl ER tablets 2
Methylphenidate HCl ER for suspension	Drug	Methylphenidate HCl ER for suspension

Primary outcome

Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products
Time frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day
The Permanent Product Measure of Performance (PERMP) involves objective individualized mathematics tests. Scores will be obtained ten times on each classroom day at pre-dose, and at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose. PERMP Attempted is reported here. Scale ranges 0 math questions answered to 400 math questions answered. The more number of questions answered (better score), the higher the PERMP Attempted score is.
Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products
Time frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day
The Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) scale is a validated, 13-item rating of subjective impairment of classroom behaviors (0 = normal/no impairment; 1 = slight impairment; 2 = mild impairment; 3 = moderate impairment; 4 = severe impairment; 5 = very severe impairment; 6 = maximal impairment). The SKAMP consists of four subscales: SKAMP-Attention, SKAMP-Deportment, SKAMP-Quality of Work, and SKAMP-Compliance, in addition to SKAMP-Total (reported here). SKAMP-Total is a sum of the four sub-scales and has a range of 0-78. The higher the score, the higher the impairment. Scores will be obtained during each classroom cycle during each full laboratory classroom day at pre-dose, and at 0.5, 1.5, 2.5, 4, 5, 6, 8, 10, and 12 hours post-dose. The scores will be based on the child's behavior during 20 minutes of each cycle.
Maximum Drug Concentration Observed (Cmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products
Time frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day
PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Cmax will be measured. The objectives of this measure is to estimate PK metrics, including Cmax, appropriate for characterizing rate and extent of absorption in each phase of the drug release and the evaluate the disposition and eliminating processes for each medication studied. The minimum value is pg/mL and there is was no maximum defined prior to the interventions.
Time to Reach Cmax (Tmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products
Time frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day
PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Tmax will be measured

Results and safety

Results posted to the registry on 10 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	80	72

Primary outcome: Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products

Time frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day. Mean (Standard Deviation). Unit: score on a scale

Measure	Methylphenidate HCl ER Tablets 1 n = 67	Placebo n = 72	Methylphenidate HCl ER Tablets 2 n = 66	Methylphenidate HCl ER for Suspension n = 68
HOUR 0	66.925 (43.7199)	95.361 (53.7921)	80.621 (57.0923)	92.176 (70.6378)
HOUR .5	78.463 (58.8659)	90.194 (67.6144)	88.333 (73.9824)	114.294 (76.9904)
HOUR 1.5	112.493 (62.1631)	89.366 (74.0415)	112.364 (70.9701)	131.191 (65.958)
HOUR 2.5	124.313 (65.4757)	86.236 (61.5375)	127.848 (71.7946)	139.132 (75.4724)
HOUR 4	120.985 (64.1158)	85.986 (63.3276)	130.591 (65.7204)	129.735 (70.0097)
HOUR 5	103.985 (58.6211)	71.718 (56.1392)	117.879 (63.5952)	122.91 (72.3134)
HOUR 6	107.303 (64.5355)	73.42 (48.0843)	112.985 (68.729)	124.862 (68.9096)
HOUR 8	117.403 (66.8252)	82.408 (59.657)	123.803 (65.2423)	97.358 (58.9822)

Population analysed: Note that not all participants who entered the study completed all arms and all time points, hence the discrepancy in number of participants analyzed between arms and different time points.

Primary outcome: Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products

Time frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day. Mean (Standard Deviation). Unit: units on a scale

Measure	Methylphenidate HCl ER Tablets 1 n = 67	Placebo n = 72	Methylphenidate HCl ER Tablets 2 n = 66	Methylphenidate HCl ER for Suspension n = 68
HOUR 0	36.4328 (13.1209)	27.7917 (13.475)	34.2879 (14.4497)	33.4706 (14.7855)
HOUR .5	35.2836 (15.2204)	30.7361 (14.8029)	32.1061 (13.2875)	27.0588 (16.1466)
HOUR 1.5	23.4328 (15.9917)	33.9722 (15.354)	25.4091 (13.8775)	17.8676 (12.9233)
HOUR 2.5	20.0746 (12.6087)	33.4861 (13.2399)	20.3939 (13.4163)	15.8088 (10.9466)
HOUR 4	19.1642 (12.216)	33.4028 (13.7888)	15.7576 (10.5233)	17.4412 (12.3462)
HOUR 5	22.3881 (12.7588)	36.2917 (14.1962)	17.1061 (11.9526)	20.6765 (13.3108)
HOUR 6	22.1642 (12.8766)	35.00 (14.7601)	15.8636 (10.5158)	22.8382 (14.8078)
HOUR 8	21.0448 (11.8186)	35.0972 (14.4038)	19.3788 (12.0509)	28.3382 (14.6548)

Population analysed: Note that not all participants who entered the study completed all arms. Thus, the number differs between the arms to reflect the number of participants who provided data for that arm. N=67 for all MPH HCl ER tab 1 time points. N=72 for all placebo time points. N=66 for all MPH HCl tab 2 time points. N=68 for all MPH Hcl ER susp timepoints.

Primary outcome: Maximum Drug Concentration Observed (Cmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products

Time frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day. Mean (Standard Deviation). Unit: pg/mL

Measure	Methylphenidate HCl ER Tablets 1 n = 76	Placebo n = 76	Methylphenidate HCl ER Tablets 2 n = 76	Methylphenidate HCl ER for Suspension n = 76
Value	76339 (55690)	4327 (4594)	81611 (46702)	81498 (66961)

Population analysed: 76 participants entered the double-blind randomization phase and each participant provided at least one data point for these analyses.

Primary outcome: Time to Reach Cmax (Tmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products

Time frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day. Mean (Standard Deviation). Unit: Hours

Measure	Methylphenidate HCl ER Tablets 1 n = 76	Placebo n = 76	Methylphenidate HCl ER Tablets 2 n = 76	Methylphenidate HCl ER for Suspension n = 76
Value	7.35 (3.05)	4.7 (2.99)	6.35 (2.22)	3.97 (2.19)

Population analysed: 76 participants entered the double-blind randomization phase and each participant provided at least one data point for these analyses.

Adverse events

Time frame: Baseline (Week 0) to Visit 14 (Week 12) or Drop Visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Methylphenidate HCl ER Tablets 1	0 of 80 (0%)	69 of 80 (86.3%)	0 of 80
Placebo	0 of 74 (0%)	12 of 74 (16.2%)	0 of 74
Methylphenidate HCl ER Tablets 2	0 of 73 (0%)	20 of 73 (27.4%)	0 of 73
Methylphenidate HCl ER for Suspension	0 of 74 (0%)	23 of 74 (31.1%)	0 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Spencer, MD principal investigator

Massachusetts General Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products (time frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02536105.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.