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Guanfacine

Phase 3

Attention Deficit Hyperactivity Disorder | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jul 2, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment338
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01244490Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)PHASE3 COMPLETED 338 — — Jan 17, 2011May 1, 2013Jul 2, 202166 United States, Austria +11
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Study Endpoints
Primary Endpoints
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF)
Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years

The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.

Secondary Endpoints
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF
Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
Change From Baseline in the WFIRS-P Family Domain Score at Week 10/13 - LOCF
Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Extended-release Guanfacine HydrochlorideEXPERIMENTAL -
Atomoxetine HydrochlorideOTHERActive Reference
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Extended-release Guanfacine HydrochlorideDRUGTablet, once daily, optimised dose (1mg to 7mg based on age and weight), 6-week maintenance duration on optimised dose.
Atomoxetine HydrochlorideDRUGCapsule, once daily, optimised dose (10mg to 100mg based on weight), 8-9-weeks maintenance duration on optimised dose
Placebo ComparatorDRUGPlacebo
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Eligibility Criteria
Age Range6 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites66

Inclusion Criteria: 1. Male or female, aged 6 17 years at the time of consent/assent at Screening (Visit 1). 2. Subject's parent or legally authorised representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating...

Countries:United StatesAustriaCanadaFranceGermanyIrelandItalyPolandRomaniaSpainSwedenUkraineUnited Kingdom
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