Back to results

Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

methylphenidate HCl ERCT

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

48 Months - 69 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female child 4-5 years of age at screening.
Signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable)
Meets DSM-5 criteria for ADHD based on the K-SADS-PL.
ADHD RS-IV Preschool-Home Version score at Screening and Baseline >/= 90th percentile for gender and age in >/=1 of the following: hyperactive-impulsive subscale, inattentive subscale, or total score.
Peabody Picture Vocabulary Test 4 (PPVT-4)Standard Score >/=70.
Child Global Assessment Scale (CGAS) score </= 55.
History of an adequate course of non medication treatment for ADHD based on investigator judgment or, where such treatments are not available, the severity of the subject's ADHD symptoms are such that medication treatment is deemed necessary by the investigator.

Exclusion Criteria:

Treated with atomoxetine within 30 days prior to the Baseline.
Received any investigational products or devices within 30 days prior to the Baseline visit.
History of stimulant nonresponse, intolerability or hypersensitivity to any dose of methylphenidate or other stimulant.If a subject has a known allergy to D&C red #30, he/she should not be enrolled in the study.
An intelligence quotient (IQ) <70.
History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality.
Less than 5th percentile for height or weight at Screening.
History of recent clinically significant self-harming behaviors.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

methylphenidate HCl ERCT

Arm Description

methylphenidate HCl ERCT

Outcomes

Primary Outcome Measures

PK parameter-Tmax

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

PK parameter- Cmax

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

PK parameter- AUClast

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

PK parameter-AUC0-2

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

PK parameter-AUC2-6

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

PK parameter-AUC6-24

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

PK parameter-AUCinf

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

PK parameter- t1/2

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

PK parameter-CL/F

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

PK parameter-Vz/F

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

Secondary Outcome Measures

incidence of treatment emergent adverse events (safety and tolerability)

Full Information

NCT ID

NCT03546400

First Posted

May 4, 2018

Last Updated

October 30, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03546400

Brief Title

Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.

Official Title

A Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Withdrawn

Why Stopped

The study was cancelled prior to the enrollment of any participants.

Study Start Date

September 25, 2018 (Anticipated)

Primary Completion Date

December 3, 2020 (Anticipated)

Study Completion Date

December 3, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

2-week open-label safety, tolerability and pharmacokinetic study of methylphenidate HCl ERCT in 4-5 year old children with ADHD.

Detailed Description

Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder (ADHD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

methylphenidate HCl ERCT

Arm Type

Other

Arm Description

methylphenidate HCl ERCT

Intervention Type

Drug

Intervention Name(s)

methylphenidate HCl ERCT

Intervention Description

methylphenidate HCl ERCT

Primary Outcome Measure Information:

Title

PK parameter-Tmax

Description

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

Time Frame

2 weeks

Title

PK parameter- Cmax

Description

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

Time Frame

2 weeks

Title

PK parameter- AUClast

Description

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

Time Frame

2 weeks

Title

PK parameter-AUC0-2

Description

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

Time Frame

2 weeks

Title

PK parameter-AUC2-6

Description

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

Time Frame

2 weeks

Title

PK parameter-AUC6-24

Description

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

Time Frame

2 weeks

Title

PK parameter-AUCinf

Description

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

Time Frame

2 weeks

Title

PK parameter- t1/2

Description

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

Time Frame

2 weeks

Title

PK parameter-CL/F

Description

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

Time Frame

2 weeks

Title

PK parameter-Vz/F

Description

PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

incidence of treatment emergent adverse events (safety and tolerability)

Description

incidence of treatment emergent adverse events (safety and tolerability)

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

48 Months

Maximum Age & Unit of Time

69 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female child 4-5 years of age at screening. Signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable) Meets DSM-5 criteria for ADHD based on the K-SADS-PL. ADHD RS-IV Preschool-Home Version score at Screening and Baseline >/= 90th percentile for gender and age in >/=1 of the following: hyperactive-impulsive subscale, inattentive subscale, or total score. Peabody Picture Vocabulary Test 4 (PPVT-4)Standard Score >/=70. Child Global Assessment Scale (CGAS) score </= 55. History of an adequate course of non medication treatment for ADHD based on investigator judgment or, where such treatments are not available, the severity of the subject's ADHD symptoms are such that medication treatment is deemed necessary by the investigator. Exclusion Criteria: Treated with atomoxetine within 30 days prior to the Baseline. Received any investigational products or devices within 30 days prior to the Baseline visit. History of stimulant nonresponse, intolerability or hypersensitivity to any dose of methylphenidate or other stimulant.If a subject has a known allergy to D&C red #30, he/she should not be enrolled in the study. An intelligence quotient (IQ) <70. History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality. Less than 5th percentile for height or weight at Screening. History of recent clinically significant self-harming behaviors.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7491020&StudyName=An+Open+Label+Pharmacokinetic+Study+Of+Methylphenidate+Extended+Release+Chewable+Tablet+%28erct%29+In+Adhd+Patients+Aged+4-5+Years+Old

Description

To obtain contact information for a study center near you, click here.

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7491020&StudyName=A+Phase+4%2C+Open+Label%2C+Safety%2C+Tolerability+And+Pharmacokinetic+Study+Of+Quillichew+Extended+Release+Chewable+Tablets+%28methylphenidate+Hcl+Extended+Release+Chewable+Tablets+%5Berct%5D%29+In+4+5+Year+Old+Children+With+Attention+Deficit+Hyperactivity+Disorder+%28adhd%29

Description

To obtain contact information for a study center near you, click here.

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7491020&StudyName=A+Phase+4%2C+Open-label%2C+Safety%2C+Tolerability+And+Pharmacokinetic+Study+Of+Quillichew+%28methylphenidate+Hydrochloride+%28hcl%29%29+Extended+Release+Chewable+Tablets+%28erct%29+In+4+5+Year+Old+Children+With+Attention+Deficit+Hyperactivity+Disorder+%28adhd%29

Description

To obtain contact information for a study center near you, click here.

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7491017&StudyName=A+Multi-center%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+Evaluating+The+Safety+And+Efficacy+Of+Quillivant+Xr+In+The+Treatment+Of+Pre-school+Aged+Children+With+Adhd

Description

To obtain contact information for a study center near you, click here.

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7491017&StudyName=A+Phase+4%2C+Double-blind%2C+Randomized%2C+Parallel+Group%2C+Placebo-controlled+Study+Of+The+Efficacy+And+Safety+Of+Quillichew+Extended+Release+Chewable+Tablets+%28methylphenidate+Hcl+Extended+Release+Chewable+Tablets+%28erct%29%29++In+4-5+Year+Old+Children+With+Attention+Deficit+Hyperactivity+Disorder+%28adhd%29.

Description

To obtain contact information for a study center near you, click here.

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7491017&StudyName=A+Phase+4%2C+Double-blind%2C+Randomized%2C+Parallel+Group%2C+Placebo-controlled+Study+Of+The+Efficacy+And+Safety+Of+Quillichew+%28methylphenidate+Hydrochloride+%28hcl%29%29+Extended+Release+Chewable+Tablets+%28erct%29+In+4-5+Year+Old+Children+With+Attention+Deficit+Hyperactivity+Disorder+%28adhd%29

Description

To obtain contact information for a study center near you, click here.

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7491020&StudyName=A+Phase+4%2C+Open-label%2C+Safety%2C+Tolerability+And+Pharmacokinetic+Study+Of+Methylphenidate+Hydrochloride+%28hcl%29+Extended+Release+Chewable+Tablet+%28erct%29+In+4-5+Year+Old+Children+With+Attention+Deficit+Hyperactivity+Disorder+%28adhd%29

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.

We'll reach out to this number within 24 hrs