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Methylphenidate

Phase 3

ADHD | Small molecule | Psychiatry |Novartis AG|Last Updated: Dec 21, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment130

FDA Designations

No designations recorded

Clinical trial landscape

Methylphenidate · 1 trial · 1 indication

Phase 3 1
NCT00254878Placebo-Controlled Comparison of Two Different Brands of Modified-Release Oral Dosage Forms Regarding Safety and Efficacy in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14ADHD
COMPLETED130 Analytics
PHASE3COMPLETED
Placebo-Controlled Comparison of Two Different Brands of Modified-Release Oral Dosage Forms Regarding Safety and Efficacy in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14
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Study Endpoints

Primary Endpoints

Attention and deportment measured at 1.5, 3.0 and 4.5 hours after drug intake

Secondary Endpoints

7 week's treatment with two different brands of modified-release oral dosage forms of methylphenidate-HCl on attention, deportment, behavior and math in children with attention deficit hyperactivity disorder (ADHD) aged 6 - 14
Safety of 7 week's treatment with two different brands of modified-release oral dosage forms of methylphenidate-HCl
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
Methylphenidate hydrochlorideDRUG -
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Eligibility Criteria

Age Range6 Years to 14 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Patients who meet all of the following inclusion criteria will be eligible for enrollment in the study: * Male and female patients aged 6-14. * Patients having a diagnosis of ADHD of any type according to DSM-IV criteria, as established by history, psychiatric examination and a...

Countries:Germany
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Competitive Landscape -ADHD 3 trials

CompanyTickerTrialsLead PhaseDrugs
Supernus Pharmaceuticals, Inc.SUPN1PHASE3SPN-812
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Frequently asked questions about Methylphenidate

What is Methylphenidate used for in ADHD?

Methylphenidate is a small molecule used for the treatment of attention deficit hyperactivity disorder (ADHD) in children. It is being developed by Novartis AG as a modified-release oral dosage form. The drug is currently in Phase 3 clinical development for this indication.

Who makes Methylphenidate?

Methylphenidate is being developed by Novartis AG, a pharmaceutical company listed on the stock exchange under the ticker NVS. The drug is in Phase 3 clinical development for the treatment of ADHD in children aged 6 to 14 years.

What phase is Methylphenidate in?

Methylphenidate is in Phase 3 clinical development. A Phase 3 trial has been completed for the drug in children with ADHD. The drug is investigational and has not been approved for use.

What clinical trials is Methylphenidate in?

Methylphenidate has one completed Phase 3 clinical trial, identified as NCT00254878. This trial was a placebo-controlled comparison of two different brands of modified-release oral dosage forms in children with ADHD aged 6 to 14 years. The trial enrolled 130 participants and was conducted in Germany.

Is Methylphenidate the same as a modified-release oral dosage form?

Methylphenidate is being studied as a modified-release oral dosage form. The completed Phase 3 trial compared two different brands of modified-release oral dosage forms of the drug. The trial was double-blind and randomized, though it did not use a control group.