Attention Deficit Disorder With HyperactivityPhase 2NCT00202605
Safety and Efficacy of SPD465 in Adults With ADHD
A Phase 2 study testing Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate in people with Attention Deficit Disorder With Hyperactivity, run by Shire at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate
- How many people
- 72 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Sep 2005to 6 Jan 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bayou City Research, Ltd.
Houston, Texas
UCI Child Development Center
Irvine, California
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada
Clinical Study Center
Little Rock, Arkansas
About this study
Official title: A Phase II, Randomized, Double-Blind, Multi-center, Placebo-controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
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.
- Being tested
- Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PERMP (Permanent Product Measure of Performance)
Measured: 0.5 hours pre-dosing
PERMP (Permanent Product Measure of Performance)
Measured: 2 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Measured: 4 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Measured: 8 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Measured: 12 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Measured: 14 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Measured: 16 hours post-dosing
Secondary outcomes (4)
Time Segment Rating System (ADHD-RS[TSRS])
Measured: 5½, 11, and 16½ hours post-dosing
Subject self report (ADHD-SRS) of ADHD
Measured: approximately 5½, 11, and 16½ hours post-dosing
Treatment emergent adverse events
Measured: Throughout the study period of approximately 3.25 months.
Modified Pittsburgh Sleep Quality Index (PSQI)
Measured: Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study start29 Sep 2005
- Primary completion6 Jan 2006
- Study completion6 Jan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 72 participants
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202605
- Sponsor's protocol ID
- SPD465-203
- Status last verified
- Jun 2021
- First submitted
- 12 Sep 2005
- Last updated
- 24 Jun 2021
- Results posted
- No
Publications
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.
PubMed 29087231
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Multi-center, Placebo-controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00202605
- Acronym / sponsor ID
- SPD465-203
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2005 (actual)
- Primary completion
- 6 Jan 2006 (actual)
- Study completion
- 6 Jan 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate | Drug | – |
Primary outcome
PERMP (Permanent Product Measure of Performance)
Time frame: 0.5 hours pre-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 2 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 4 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 8 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 12 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 14 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 16 hours post-dosing
4 secondary outcomes
Time Segment Rating System (ADHD-RS[TSRS])
Time frame: 5½, 11, and 16½ hours post-dosing
Subject self report (ADHD-SRS) of ADHD
Time frame: approximately 5½, 11, and 16½ hours post-dosing
Treatment emergent adverse events
Time frame: Throughout the study period of approximately 3.25 months.
Modified Pittsburgh Sleep Quality Index (PSQI)
Time frame: Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Derived from this study: PubMed 29087231Wigal 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.
Related trials for Attention Deficit Disorder With Hyperactivity
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate in people with Attention Deficit Disorder With Hyperactivity, run by Shire at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PERMP (Permanent Product Measure of Performance) (time frame: 0.5 hours pre-dosing). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00202605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.