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Focalin

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 Trials2
Total Enrollment180

FDA Designations

No designations recorded

Clinical trial landscape

Focalin · 2 trials · 1 indication

Phase 3 2
NCT00141063Safety and Efficacy Study of Dexmethylphenidate in Children With ADHDADHD
COMPLETED90 Analytics
NCT00141050Safety and Efficacy Study of Dexmethylphenidate in Children With ADHDADHD
COMPLETED90 Analytics
PHASE3COMPLETED
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
ADHDUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
ADHDUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in attention and deportment measured at 2 hours post-dose

Secondary Endpoints

Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
Focalin XRDRUG -
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Eligibility Criteria

Age Range6 Years to 12 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * DSM-IV diagnosis of ADHD * Males and females aged 6-12 Exclusion Criteria: * Inability of understand or follow instructions * Is pregnant * Diagnosis of tic disorder * History of seizure disorder

Countries:United States
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Competitive Landscape -ADHD 3 trials

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

What is Focalin used for?

Focalin is used for the treatment of attention deficit hyperactivity disorder (ADHD). It is a small molecule drug being developed by Novartis AG for this psychiatric condition. The drug is currently in Phase 3 clinical development, meaning it is still investigational and has not yet been approved by regulatory authorities.

Who makes Focalin?

Focalin is being developed by Novartis AG, a pharmaceutical company traded on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of Focalin in patients with ADHD.

What phase is Focalin in?

Focalin is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. Two Phase 3 clinical trials have been completed to evaluate its safety and efficacy in children with ADHD.

What clinical trials is Focalin in?

Focalin has been studied in two completed Phase 3 clinical trials: NCT00141050 and NCT00141063. Both trials were conducted in the United States and enrolled 90 children each, for a total of 180 participants. The trials were randomized, double-blind, and uncontrolled, and included children aged 6 years and older with ADHD.

Is Focalin the same as dexmethylphenidate?

Focalin is the brand name for dexmethylphenidate, a medication used to treat ADHD. The clinical trials for Focalin, identified as NCT00141050 and NCT00141063, were titled 'Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD,' confirming that Focalin and dexmethylphenidate refer to the same drug.