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Mixed salts of a single-entity amphetamine

Phase 3

ADHD | Small molecule | Psychiatry |Takeda Pharmaceutical Company Limited|Trials Updated: Jun 8, 2021

Mixed salts of a single-entity amphetamine development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Nov 2007

Mixed salts of a single-entity amphetamine target and mechanism

ModalitySmall molecule

Also known as Mixed salts of a single-entity amphetamine (ADDERALL XR), ADDERALL XR

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment365

FDA Designations

No designations recorded

Mixed salts of a single-entity amphetamine clinical trials

Mixed salts of a single-entity amphetamine · 2 trials · 2 indications

Phase 3 2
NCT00557960ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHDAttention Deficit Disorder With Hyperactivity
COMPLETED36 Analytics
NCT00507065Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)ADHD
COMPLETED329 Analytics
PHASE3COMPLETED
ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD
Attention Deficit Disorder With HyperactivityUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)
ADHDUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Driving Safety Score derived by the driving simulator
Weeks 3 & 6
Change from baseline to final visit of the double-blind phase of the study in the ADHD-RS-IV score in the cohort weighing less than or equal to 75 kg.
approximately 4 weeks

Secondary Endpoints

Driving Safety Scores at individual time points
2, 7, and 12 hours post-dose at Weeks 3 & 6
Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire
Weeks 3 & 6
AEs, laboratory screens, PE, vital signs, ECG
6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Adderall XR (10 mg)EXPERIMENTAL -
Adderall XR (20 mg)EXPERIMENTAL -
Adderall XR (30 mg)EXPERIMENTAL -
Adderall XR (40 mg)EXPERIMENTAL -
placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Mixed salts of a single-entity amphetamineDRUG -
Atomoxetine hydrochlorideDRUG -
Mixed salts of a single-entity amphetamine (ADDERALL XR)DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range19 Years to 25 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * primary diagnosis of ADHD * not naive to pharmacologic ADHD treatment * valid driver's license with a minimum of 3 years driving experience Exclusion Criteria: * recent history of drug dependence or substance use disorder * any specific cardiac condition that would, in the o...

Countries:United States
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Competitive Landscape -ADHD 10 trials

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Frequently asked questions about Mixed salts of a single-entity amphetamine

What is ADDERALL XR used for?

ADDERALL XR is used to treat Attention Deficit Hyperactivity Disorder (ADHD), including Attention Deficit Disorder With Hyperactivity. It is a small molecule treatment studied in adolescents aged 13 to 17 and in adults with ADHD. It is developed by Takeda Pharmaceutical Company Limited.

Who makes ADDERALL XR?

ADDERALL XR is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the company associated with the clinical development program for this mixed salts of a single-entity amphetamine product in ADHD.

What phase is ADDERALL XR in?

ADDERALL XR has been studied in Phase 3 clinical development for ADHD. Its trials are listed as completed, and no active trials are currently recorded. The program includes a completed Phase 3 study in adolescents aged 13 to 17 and a completed Phase 3 simulated driving study in adults.

What clinical trials is ADDERALL XR in?

ADDERALL XR has been evaluated in completed Phase 3 trials, including NCT00507065, which studied safety and efficacy in adolescents aged 13 to 17 with ADHD and enrolled 329 participants, and NCT00557960, which compared ADDERALL XR and atomoxetine to placebo on simulated driving safety and cognitive functioning in adults with ADHD.

Is ADDERALL XR the same as mixed salts of a single-entity amphetamine?

Yes, ADDERALL XR is the brand name for mixed salts of a single-entity amphetamine. The two names refer to the same product, so searches for either term describe the same ADHD treatment developed by Takeda Pharmaceutical Company Limited.

How was ADDERALL XR studied in clinical trials?

ADDERALL XR trials were randomized, double-blind, and placebo-controlled. The adolescent Phase 3 study NCT00507065 enrolled 329 participants aged 13 and older with ADHD, while NCT00557960 enrolled 36 adults and assessed simulated driving safety, performance, and cognitive functioning.