Attention Deficit Hyperactivity DisorderPhase 3NCT00458445
A Study of SPD465 in Young Adult Drivers With Attention-Deficit Hyperactivity Disorder (ADHD) Using Driving Simulators
A Phase 3 study testing SPD465 in people with Attention Deficit Hyperactivity Disorder, run by Shire at 1 site in United States.
Trial summary
The purpose of this study is to determine whether SPD465 is safe and effective in the treatment of ADHD in young adult drivers after a duration of 16 hours. Read more about this study
- Who is it for?
- Ages 19 to 25 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- SPD465
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2007to 15 Jun 2007
- Phase
- Phase 3
- 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 19 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject must have a valid driver's license with a minimum of 3 years of driving experience.
- Subject reports daily driving activity.
- Subject is fluent in English.
- Subject must be male or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.
- Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities
- Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria
Who cannot join
- Subject is significantly underweight or morbidly obese.
- Subject has a controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations that, in the opinion of the examining Physician, will contraindicate SPD465 treatment or confound efficacy or safety assessments.
- Subject with a lifetime history of psychosis or bipolar disorder.
- Subject with any concurrent chronic or acute illness or unstable medical condition, either treated or untreated.
- Subject with a history of mental retardation or a severe learning disability.
- Subject is naïve to ADHD treatment with methylphenidate or amphetamine.
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- Subject has a history of glaucoma or narrow angle glaucoma.
- Subject has a history of seizure (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
- Subject has known cardiac structural abnormalities as well as any other condition that may affect cardiac performance.
- Subject has clinically significant ECG or laboratory abnormalities at Screening or Baseline.
- Subject has a history of hypertension or has a resting sitting systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg10.
- Subject has used any psychoactive prescription medication or over-the-counter (OTC) medication requiring more than a 28-day washout. Hormonal contraceptives are acceptable.
- Subject has a documented allergy, intolerance, or documented history of non-responsivity to amphetamine.
- Subject currently has (or had a history within the last 6 months) a substance use disorder (excluding nicotine).
- Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
- Female subject is pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With SPD465 Compared to Placebo on Simulated Driving Safety and Performance in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
The purpose of this study is to determine whether SPD465 is safe and effective in the treatment of ADHD in young adult drivers after a duration of 16 hours.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- SPD465, Placebo
- Keywords
- Attention-Deficit Hyperactivity Disorder (ADHD)
- 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
PlaceboOther
Placebo is a material that may look similar to SPD465, however, contains no active drug.
| Study group | Role | What they receive |
|---|---|---|
| SPD465 then Placebo | Experimental | Not described Receives: Drug: SPD465; Other: Placebo |
| Placebo then SPD465 | Experimental | Not described Receives: Drug: SPD465; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulated Driver Safety (DS) Score averaged over 3 driving assessments at one interim and one final visit.
Measured: Interim visit = Week 3; Final visit = Week 7.
Secondary outcomes (3)
Interim & final visits: Attention-Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV)
Measured: Interim visit = Week 3; Final visit = Week 7.
Interim & final visits: Clinical Global Impressions of Improvement (CGI-I)
Measured: Interim visit = Week 3; Final visit = Week 7.
Interim & final visits: Self-Rating of Simulated Driver Safety (DS) Performance Questionnaire
Measured: Post DS Testing - Interim visit = Week 3; Post DS Testing - Final visit = Week 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2007 (estimated)
- Study start30 Apr 2007
- Primary completion15 Jun 2007
- Study completion15 Jun 2007
Why it stopped: This study was stopped by the sponsor before enrollment based on a non-safety related corporate decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT00458445
- Sponsor's protocol ID
- SPD465-311
- Status last verified
- Jul 2021
- First submitted
- 2 Apr 2007
- Last updated
- 6 Jul 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With SPD465 Compared to Placebo on Simulated Driving Safety and Performance in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00458445
- Acronym / sponsor ID
- SPD465-311
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention-Deficit Hyperactivity Disorder (ADHD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was stopped by the sponsor before enrollment based on a non-safety related corporate decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2007 (actual)
- Primary completion
- 15 Jun 2007 (actual)
- Study completion
- 15 Jun 2007 (actual)
- First posted
- 10 Apr 2007 (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 this study is to determine whether SPD465 is safe and effective in the treatment of ADHD in young adult drivers after a duration of 16 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPD465 then Placebo | Experimental | Drug: SPD465, Other: Placebo |
| Placebo then SPD465 | Experimental | Drug: SPD465, Other: Placebo |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject must have a valid driver's license with a minimum of 3 years of driving experience.
- Subject reports daily driving activity.
- Subject is fluent in English.
- Subject must be male or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.
- Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities
Key exclusion criteria (16 listed)
- Subject is significantly underweight or morbidly obese.
- Subject has a controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations that, in the opinion of the examining Physician, will contraindicate SPD465 treatment or confound efficacy or safety assessments.
- Subject with a lifetime history of psychosis or bipolar disorder.
- Subject with any concurrent chronic or acute illness or unstable medical condition, either treated or untreated.
- Subject with a history of mental retardation or a severe learning disability.
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 |
|---|---|---|
| SPD465 | Drug | Placebo then SPD465, SPD465 then Placebo |
| PlaceboPlacebo is a material that may look similar to SPD465, however, contains no active drug. | Other | Placebo then SPD465, SPD465 then Placebo |
Primary outcome
Simulated Driver Safety (DS) Score averaged over 3 driving assessments at one interim and one final visit.
Time frame: Interim visit = Week 3; Final visit = Week 7.
3 secondary outcomes
Interim & final visits: Attention-Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV)
Time frame: Interim visit = Week 3; Final visit = Week 7.
Interim & final visits: Clinical Global Impressions of Improvement (CGI-I)
Time frame: Interim visit = Week 3; Final visit = Week 7.
Interim & final visits: Self-Rating of Simulated Driver Safety (DS) Performance Questionnaire
Time frame: Post DS Testing - Interim visit = Week 3; Post DS Testing - Final visit = Week 7.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPD465 in people with Attention Deficit Hyperactivity Disorder, run by Shire at 1 site 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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Simulated Driver Safety (DS) Score averaged over 3 driving assessments at one interim and one final visit. (time frame: Interim visit = Week 3; Final visit = Week 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2021.