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Quillivant

Phase 3

Attention Deficit Hyperactivity Disorder | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Jun 26, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Quillivant · 1 trial · 1 indication

Phase 3 1
NCT00904670Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)Attention Deficit Hyperactivity Disorder
COMPLETED45 Analytics
PHASE3COMPLETED
Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose
Hour 4 post-dose

The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.

Secondary Endpoints

Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale
0.75, 2, 8, 10, 12 hours post-dose
SKAMP Attention Subscale Score Over 12 Hours
0.75, 2, 4, 8, 10, 12 hours post-dose
SKAMP Deportment Subscale Score Over 12 Hours
0.75, 2, 4, 8, 10, 12 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ActiveEXPERIMENTAL -
ComparatorPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Quillivant Oral Suspension XRDRUGOral Suspension 25mg/5mL; 20-60 mg/day
PlaceboDRUGMatching Placebo Oral Suspension 25mg/5mL; 20-60 mg/day
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Eligibility Criteria

Age Range6 Years to 12 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or female from 6 to 12 years of age at the time of screening, inclusive. * Diagnosis of ADHD by a Psychiatrist, Psychologist, Developmental Pediatrician, or a Pediatrician meeting diagnostic criteria for ADHD (DSM-IV). A Schedule for Affective Disorders and Schizophrenia ...

Countries:United States
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Frequently asked questions about Quillivant

What is Quillivant used for?

Quillivant is a small molecule medication used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is being developed by Pfizer, Inc. and is currently in Phase 3 clinical development. Quillivant is an oral suspension formulation intended to manage symptoms of ADHD.

Who makes Quillivant?

Quillivant is being developed by Pfizer, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 3 clinical development for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

What phase is Quillivant in?

Quillivant is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in a completed Phase 3 clinical trial.

What clinical trials is Quillivant in?

Quillivant has one completed Phase 3 clinical trial registered under NCT00904670. This trial, titled 'Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)', was a randomized, double-blind, placebo-controlled study conducted in the United States with 45 participants aged 6 years and older.

Is Quillivant the same as Quillivant XR?

Yes, Quillivant is also known as Quillivant XR. The clinical trial NCT00904670 specifically refers to the drug as 'Quillivant Oral Suspension (Quillivant XR)'. This alternative name is used in the context of the extended-release oral suspension formulation being studied for ADHD.