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Neutral salts of dextroamphetamine, USP, amphetamine, USP, d-amphetamine saccharate, d, I-amphetamine aspartate

Phase 3

Attention Deficit Disorder With Hyperactivity | Small molecule | Psychiatry |Takeda Pharmaceutical Company Limited|Last Updated: Aug 23, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment1,229

FDA Designations

No designations recorded

Clinical trial landscape

Neutral salts of dextroamphetamine, USP, amphetamine, USP, d-amphetamine saccharate, d, I-amphetamine aspartate · 4 trials · 1 indication

Phase 3 3Phase 2 1
NCT00152022Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.Attention Deficit Disorder With Hyperactivity
COMPLETED412 Analytics
NCT00152035Safety of SPD465 in Treating Adults With ADHD.Attention Deficit Disorder With Hyperactivity
COMPLETED505 Analytics
NCT00150579Efficacy and Safety of SPD465 in Adults With ADHDAttention Deficit Disorder With Hyperactivity
COMPLETED240 Analytics
PHASE3COMPLETED
Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.
Attention Deficit Disorder With Hyperactivity
NCT00152022412
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PHASE3COMPLETED
Safety of SPD465 in Treating Adults With ADHD.
Attention Deficit Disorder With Hyperactivity
NCT00152035505
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PHASE3COMPLETED
Efficacy and Safety of SPD465 in Adults With ADHD
Attention Deficit Disorder With Hyperactivity
NCT00150579240
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Study Endpoints

Primary Endpoints

The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
Baseline (following ADHD medication washout of 7-28 days)

The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.

The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.
Throughout the study period of approximately 20 months
Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment.
Baseline, and the Endpoint (average of weeks 5, 6, 7).

The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.

PERMP (Permanent Product Measure of Performance)
0.5 hours pre-dosing

Secondary Endpoints

Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET)
Weeks 1, 2, 3, 4, 5, & 6
Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits
Baseline visit and weeks 1, 2, 3, 4, 5, & 6
Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits.
Baseline visit and weeks 1, 2, 3, 4, 5, & 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.DRUG -
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.DRUG -
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrateDRUG -
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrateDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Primary diagnosis of ADHD * Baseline ADHD-RS-IV score \>= 32 * Non-pregnant females of childbearing potential must comply with contraceptive restrictions. Exclusion Criteria: * Significantly underweight or morbidly obese * Comorbid psychiatric diagnosis with significant symp...

Countries:United States
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