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Trial record 11 of 439 for:    Methylphenidate

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

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ClinicalTrials.gov Identifier: NCT03546400
Recruitment Status : Withdrawn (The study was cancelled prior to the enrollment of any participants.)
First Posted : June 5, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Drug: methylphenidate HCl ERCT Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : September 25, 2018
Estimated Primary Completion Date : December 3, 2020
Estimated Study Completion Date : December 3, 2020


Arm Intervention/treatment
methylphenidate HCl ERCT
methylphenidate HCl ERCT
Drug: methylphenidate HCl ERCT
methylphenidate HCl ERCT




Primary Outcome Measures :
  1. PK parameter-Tmax [ Time Frame: 2 weeks ]
    PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

  2. PK parameter- Cmax [ Time Frame: 2 weeks ]
    PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

  3. PK parameter- AUClast [ Time Frame: 2 weeks ]
    PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

  4. PK parameter-AUC0-2 [ Time Frame: 2 weeks ]
    PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

  5. PK parameter-AUC2-6 [ Time Frame: 2 weeks ]
    PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

  6. PK parameter-AUC6-24 [ Time Frame: 2 weeks ]
    PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

  7. PK parameter-AUCinf [ Time Frame: 2 weeks ]
    PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

  8. PK parameter- t1/2 [ Time Frame: 2 weeks ]
    PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

  9. PK parameter-CL/F [ Time Frame: 2 weeks ]
    PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.

  10. PK parameter-Vz/F [ Time Frame: 2 weeks ]
    PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.


Secondary Outcome Measures :
  1. incidence of treatment emergent adverse events (safety and tolerability) [ Time Frame: 2 weeks ]
    incidence of treatment emergent adverse events (safety and tolerability)



Information from the National Library of Medicine

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Ages Eligible for Study:   48 Months to 69 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546400


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03546400     History of Changes
Other Study ID Numbers: B7491020
First Posted: June 5, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Methylphenidate
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents