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

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03546400
• Other study ID #: B7491020
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 25, 2018
• Est. completion date: December 3, 2020

Study information

• Verified date: October 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 3, 2020
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Months to 69 Months

Eligibility

Inclusion Criteria:

1. Male or female child 4-5 years of age at screening.

2. Signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable)

3. Meets DSM-5 criteria for ADHD based on the K-SADS-PL.

4. 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.

5. Peabody Picture Vocabulary Test 4 (PPVT—4)Standard Score >/=70.

6. Child Global Assessment Scale (CGAS) score </= 55.

7. 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:

1. Treated with atomoxetine within 30 days prior to the Baseline.

2. Received any investigational products or devices within 30 days prior to the Baseline visit.

3. 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.

4. An intelligence quotient (IQ) <70.

5. History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality.

6. Less than 5th percentile for height or weight at Screening.

7. History of recent clinically significant self-harming behaviors.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

Drug:
• methylphenidate HCl ERCT
methylphenidate HCl ERCT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameter-Tmax	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
Primary	PK parameter- Cmax	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
Primary	PK parameter- AUClast	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
Primary	PK parameter-AUC0-2	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
Primary	PK parameter-AUC2-6	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
Primary	PK parameter-AUC6-24	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
Primary	PK parameter-AUCinf	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
Primary	PK parameter- t1/2	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
Primary	PK parameter-CL/F	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
Primary	PK parameter-Vz/F	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
Secondary	incidence of treatment emergent adverse events (safety and tolerability)	incidence of treatment emergent adverse events (safety and tolerability)	2 weeks

External Links

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