Recent Updates
Recently added Catalysts

Amphetamine + SPD503

Phase 2

Attention Deficit Disorder With Hyperactivity | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jun 10, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment75
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00151996Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)PHASE2 COMPLETED 75 — — Aug 16, 2004Dec 27, 2004Jun 10, 2021 - —
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks
Baseline and 6 weeks

Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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.

Secondary Endpoints
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
6 weeks
Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total Score at 6 Weeks
Baseline and 6 weeks
Number of Participants With Improvement on Parent Global Assessment (PGA) Scores
6 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Methylphenidate + SPD503EXPERIMENTAL -
Amphetamine + SPD503EXPERIMENTAL -
Interventions
NameTypeDescription
Methylphenidate + SPD503 (Guanfacine hydrochloride)DRUG -
Amphetamine + SPD503DRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range6 Years — 17 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects with a primary diagnosis of ADHD * Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for at least 1 month, with sub-optimal control in the Investigator's opinion * Male or non-pregnant female subject who agrees to comply with any applica...

Unlock Eligibility Criteria