Attention-Deficit/Hyperactivity DisorderPhase 2NCT00928148
The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 2 study testing SPD465 and Immediate Release Amphetamine Salt in people with Attention-Deficit/Hyperactivity Disorder, run by Shire.
Trial summary
This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg) compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults with ADHD. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- SPD465 and Immediate Release Amphetamine Salt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 14 Jun 2004to 20 Nov 2004
- 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
- Adult men and non-pregnant women between the ages of 18 and 55
- Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- Baseline ADHD score of at least 24
Who cannot join
- Weight less than 100 pounds or greater than 250 pounds
- Psychiatric diagnosis such as a severe comorbid Axis II or Axis I disorder
- Pregnancy or breastfeeding
- History of seizures
- Positive urine drug screen
About this study
Official title: A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo- and Active-Controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder
This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg) compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults with ADHD. The controlled environment used in this study is an analog classroom setting adapted for a 16-hour adult day.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- SPD465, Immediate Release Amphetamine Salt, Placebo
- 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.
SPD465Drug
50 or 75 mg once daily for 7 days
Immediate Release Amphetamine SaltDrug
25 mg once daily for 7 days
PlaceboDrug
Once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| SPD465 (50 or 75 mg) | Experimental | Not described Receives: Drug: SPD465 |
| Immediate Release Amphetamine salt (25 mg) | Active comparator | Not described Receives: Drug: Immediate Release Amphetamine Salt |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the duration of efficacy of SPD465 compared to placebo and immediate release amphetamine formulation in adults with ADHD using the Permanent Product Measure of Performance (PERMP) math test
Measured: -0.5, 2, 4, 8, 12, 14 and 18 hours post-dose
Secondary outcomes (4)
To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the ADHD-rating scale (ADHD-RS)
Measured: 5, 10 and 15 hours post-dose
To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the Swanson, Kotkin, Agler, M. Flynn, and Pelham (SKAMP) scale
Measured: 5, 10, and 15 hours post-dose
To assess the impact of SPD465 compared with placebo and immediate release amphetamine on sleep as measured by the modified Pittsburgh Sleep Quality Index (PSQI)
Measured: 21 days
To evaluate the safety of SPD465 based on occurrence of treatment-emergent adverse events (TEAEs), blood pressure (BP), heart rate, electrocardiogram (ECG), and clinical laboratory findings
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study start14 Jun 2004
- Primary completion20 Nov 2004
- Study completion20 Nov 2004
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/Hyperactivity DisorderStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
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
- NCT00928148
- Sponsor's protocol ID
- SPD465-201
- Status last verified
- May 2021
- First submitted
- 23 Jun 2009
- Last updated
- 3 Jun 2021
- Results posted
- No
Publications
Wigal T, Brams M, Frick G, Yan B, Madhoo M. A randomized, double-blind study of SHP465 mixed amphetamine salts extended-release in adults with ADHD using a simulated adult workplace design. Postgrad Med. 2018 Jun;130(5):481-493. doi: 10.1080/00325481.2018.1481712. Epub 2018 Jun 18.
PubMed 29809075
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo- and Active-Controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00928148
- Acronym / sponsor ID
- SPD465-201
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2004 (actual)
- Primary completion
- 20 Nov 2004 (actual)
- Study completion
- 20 Nov 2004 (actual)
- First posted
- 25 Jun 2009 (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.
This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg) compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults with ADHD. The controlled environment used in this study is an analog classroom setting adapted for a 16-hour adult day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SPD465 (50 or 75 mg) | Experimental | Drug: SPD465 |
| Immediate Release Amphetamine salt (25 mg) | Active comparator | Drug: Immediate Release Amphetamine Salt |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult men and non-pregnant women between the ages of 18 and 55
- Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- Baseline ADHD score of at least 24
Key exclusion criteria (5 listed)
- Weight less than 100 pounds or greater than 250 pounds
- Psychiatric diagnosis such as a severe comorbid Axis II or Axis I disorder
- Pregnancy or breastfeeding
- History of seizures
- Positive urine drug screen
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 |
|---|---|---|
| SPD46550 or 75 mg once daily for 7 days | Drug | SPD465 (50 or 75 mg) |
| Immediate Release Amphetamine Salt25 mg once daily for 7 days | Drug | Immediate Release Amphetamine salt (25 mg) |
| PlaceboOnce daily for 7 days | Drug | Placebo |
Primary outcome
To assess the duration of efficacy of SPD465 compared to placebo and immediate release amphetamine formulation in adults with ADHD using the Permanent Product Measure of Performance (PERMP) math test
Time frame: -0.5, 2, 4, 8, 12, 14 and 18 hours post-dose
4 secondary outcomes
To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the ADHD-rating scale (ADHD-RS)
Time frame: 5, 10 and 15 hours post-dose
To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the Swanson, Kotkin, Agler, M. Flynn, and Pelham (SKAMP) scale
Time frame: 5, 10, and 15 hours post-dose
To assess the impact of SPD465 compared with placebo and immediate release amphetamine on sleep as measured by the modified Pittsburgh Sleep Quality Index (PSQI)
Time frame: 21 days
To evaluate the safety of SPD465 based on occurrence of treatment-emergent adverse events (TEAEs), blood pressure (BP), heart rate, electrocardiogram (ECG), and clinical laboratory findings
Time frame: 21 days
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 3 Jun 2021.
- Derived from this study: PubMed 29809075Wigal T, Brams M, Frick G, Yan B, Madhoo M. A randomized, double-blind study of SHP465 mixed amphetamine salts extended-release in adults with ADHD using a simulated adult workplace design. Postgrad Med. 2018 Jun;130(5):481-493. doi: 10.1080/00325481.2018.1481712. Epub 2018 Jun 18.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPD465 and Immediate Release Amphetamine Salt in people with Attention-Deficit/Hyperactivity Disorder, run by Shire.
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 5 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 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
To assess the duration of efficacy of SPD465 compared to placebo and immediate release amphetamine formulation in adults with ADHD using the Permanent Product Measure of Performance (PERMP) math test (time frame: -0.5, 2, 4, 8, 12, 14 and 18 hours post-dose). 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 NCT00928148, 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 3 Jun 2021.