NCT00202605

Brief Summary

The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of clinical benefit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
9 days until next milestone

Study Start

First participant enrolled

September 29, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2006

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

September 12, 2005

Last Update Submit

June 21, 2021

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (7)

  • PERMP (Permanent Product Measure of Performance)

    0.5 hours pre-dosing

  • PERMP (Permanent Product Measure of Performance)

    2 hours post-dosing

  • PERMP (Permanent Product Measure of Performance)

    4 hours post-dosing

  • PERMP (Permanent Product Measure of Performance)

    8 hours post-dosing

  • PERMP (Permanent Product Measure of Performance)

    12 hours post-dosing

  • PERMP (Permanent Product Measure of Performance)

    14 hours post-dosing

  • PERMP (Permanent Product Measure of Performance)

    16 hours post-dosing

Secondary Outcomes (4)

  • Time Segment Rating System (ADHD-RS[TSRS])

    5½, 11, and 16½ hours post-dosing

  • Subject self report (ADHD-SRS) of ADHD

    approximately 5½, 11, and 16½ hours post-dosing

  • Treatment emergent adverse events

    Throughout the study period of approximately 3.25 months.

  • Modified Pittsburgh Sleep Quality Index (PSQI)

    Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit

Interventions

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

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primary diagnosis of ADHD using DSM-IV-TR criteria (at least 6 of the 9 subtype criteria met)
  • Baseline ADHD-RS-IV score =\>24
  • IQ score of =\> 80 (using Kaufman Brief Intelligence Test)

You may not qualify if:

  • BMI \< 18.5 or \> 30 kg/m2
  • Diagnosis of Post Traumatic Stress Disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
  • History of seizure disorder or a lifetime history of any seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
  • History of uncontrolled hypertension or currently hypertensive
  • Subjects who have taken atomoxetine (STRATTERA) within 30 days prior to screening
  • Current (or history within the last 12 months) of drug dependence or substance abuse disorder according to DSM-IV-TR criteria (excluding nicotine)
  • Female subject is pregnant or lactating, less than 3 months post partum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinical Study Center

Little Rock, Arkansas, United States

Location

UCI Child Development Center

Irvine, California, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, United States

Location

Bayou City Research, Ltd.

Houston, Texas, United States

Location

Related Publications (1)

  • Wigal T, Childress A, Frick G, Yan B, Wigal S, Madhoo M. Effects of SHP465 mixed amphetamine salts in adults with ADHD in a simulated adult workplace environment. Postgrad Med. 2018 Jan;130(1):111-121. doi: 10.1080/00325481.2018.1389227. Epub 2017 Oct 31.

    PMID: 29087231DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Amphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

September 29, 2005

Primary Completion

January 6, 2006

Study Completion

January 6, 2006

Last Updated

June 24, 2021

Record last verified: 2021-06

Locations

US(4)