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Quillivant

Phase 3

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

Quillivant target and mechanism

ModalitySmall molecule

Also known as Quillivant Oral Suspension XR

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

Quillivant clinical trials

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 used to treat Attention Deficit Hyperactivity Disorder (ADHD). It is an oral suspension formulation developed for this psychiatric condition. The clinical program enrolled patients aged 6 years and older in the United States.

Who makes Quillivant?

Quillivant is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the company behind the Quillivant Oral Suspension XR product.

What phase is Quillivant in?

Quillivant has been studied in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The completed study was a randomized, double-blind, placebo-controlled trial conducted in the United States.

What clinical trials is Quillivant in?

Quillivant was evaluated in the Phase 3 trial NCT00904670, titled Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD). The trial is completed and enrolled 45 participants aged 6 years and older, with both sexes eligible and no healthy volunteers.

Is Quillivant the same as Quillivant Oral Suspension XR?

Yes, Quillivant is also known as Quillivant Oral Suspension XR. Both names refer to the same extended-release oral suspension product developed by Pfizer for the treatment of Attention Deficit Hyperactivity Disorder.

How was the Quillivant Phase 3 trial designed?

The Quillivant Phase 3 trial NCT00904670 was a randomized, double-blind, placebo-controlled study. It enrolled 45 participants with Attention Deficit Hyperactivity Disorder in the United States, included patients aged 6 years and older of all sexes, and did not enroll healthy volunteers.