Clinical trial NCT03546400: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-06-06
Enrollment: 0
Sex: ALL
Minimum age (years): 48
Maximum age (years): 69
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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.

Primary outcomes:
measure: PK parameter-Tmax
timeFrame: 2 weeks
measure: PK parameter- Cmax
timeFrame: 2 weeks
measure: PK parameter- AUClast
timeFrame: 2 weeks
measure: PK parameter-AUC0-2
timeFrame: 2 weeks
measure: PK parameter-AUC2-6
timeFrame: 2 weeks
measure: PK parameter-AUC6-24
timeFrame: 2 weeks
measure: PK parameter-AUCinf
timeFrame: 2 weeks
measure: PK parameter- t1/2
timeFrame: 2 weeks
measure: PK parameter-CL/F
timeFrame: 2 weeks
measure: PK parameter-Vz/F
timeFrame: 2 weeks
Secondary outcomes:
measure: incidence of treatment emergent adverse events (safety and tolerability)
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: