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Amphetamine+ SPD503

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment75

FDA Designations

No designations recorded

Clinical trial landscape

Amphetamine+ SPD503 · 1 trial · 1 indication

Phase 2 1
NCT00151996Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention Deficit Disorder With Hyperactivity
COMPLETED75 Analytics
PHASE2COMPLETED
Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Attention Deficit Disorder With HyperactivityUnlock trial analytics

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Methylphenidate + SPD503EXPERIMENTAL -
Amphetamine + SPD503EXPERIMENTAL -

Interventions

NameTypeDescription
Methylphenidate + SPD503 (Guanfacine hydrochloride)DRUG -
Amphetamine + SPD503DRUG -
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Eligibility Criteria

Age Range6 Years to 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...

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Frequently asked questions about Amphetamine+ SPD503

What is Amphetamine+ SPD503 used for?

Amphetamine+ SPD503 is an investigational small molecule being studied for attention deficit disorder with hyperactivity (ADHD). It is being developed by Takeda Pharmaceutical Company Limited (TAK) and is currently in Phase 2 clinical development. The drug is intended for use in children and adolescents aged 6 to 17 years.

What does Amphetamine+ SPD503 target?

Amphetamine+ SPD503 is a small molecule that contains amphetamine, a central nervous system stimulant. It is being studied for its effects on attention deficit disorder with hyperactivity (ADHD). The specific molecular target of the drug has not been disclosed in the available information.

Who makes Amphetamine+ SPD503?

Amphetamine+ SPD503 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The drug is currently in Phase 2 clinical development for attention deficit disorder with hyperactivity (ADHD).

What phase is Amphetamine+ SPD503 in?

Amphetamine+ SPD503 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed, and the drug is being studied for attention deficit disorder with hyperactivity (ADHD).

What clinical trials is Amphetamine+ SPD503 in?

Amphetamine+ SPD503 has one completed clinical trial, NCT00151996, which was a Phase 2 study titled 'Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD).' The trial enrolled 75 participants and was controlled but not randomized or double-blind.