Attention Deficit Hyperactivity Disorder (ADHD)Phase 2NCT02402166

Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children With Attention-deficit/Hyperactivity Disorder

A Phase 2 study testing SPD489 in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to gain initial safety, tolerability, pharmacokinetic, and efficacy information on SPD489 in preschool children 4-5 years old who are diagnosed with ADHD. Generating such data will provide data on the use of SPD489 in the preschool ADHD population. Read more about this study

Who is it for?: Ages 4 to 5 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder (ADHD)
What is being tested?: SPD489
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 6 sitesUnited States
Study dates: 15 Apr 2015to 30 Jun 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 4 to 5 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subject is a male or female aged 4-5 years inclusive at the time of consent. Only recruiting male subjects as of December 2015
Subject's parent or LAR must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject in accordance with the ICH GCP Guideline E6 (1996) and applicable regulations, before completing any study-related procedures.
Subject and parent/LAR are willing and able to comply with all of the testing and requirements defined in the protocol, including oversight of morning dosing. Specifically, the same parent/LAR should be available daily to dispense the dose of investigational product for the study duration.
Subject must meet DSM-IV-TR criteria for a primary diagnosis of ADHD (all subtypes) based on a detailed psychiatric evaluation conducted by a sponsor-approved clinician
Subject has an ADHD-RS-IV Preschool Version total score ≥93rd percentile at the Baseline Visit (Visit 0). For boys, this is a score of ≥32. For girls, this is a score of ≥24.
Subject has a CGI-S score ≥4 at the Baseline Visit (Visit 0).

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Subject has a Peabody Picture Vocabulary Test, Fourth Edition standard score of ≥70 at the Screening Visit (Visit -1).
Subject has undergone an adequate course of non-pharmacological treatment based on investigator judgment or the subject has a severe enough condition to consider enrollment without undergoing prior non-pharmacological treatment based on investigator judgment.
Subject has, in the opinion of the investigator, participated in a structured group activity (e.g., preschool, sports, Sunday school) so as to assess symptoms and impairment in a setting outside the home.
Subject has lived with the same parent/LAR for ≥6 months.

Who cannot join

Subject is required to or anticipates the need to take medications that have CNS effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are taking monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary.
Subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the Screening Visit (Visit -1).
Subject is well controlled on his/her current ADHD medication with acceptable tolerability.
Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that, in the investigator's opinion, would prohibit the subject from completing the study or would not be in the best interest of the subject. The additional conditions would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
Subject has failed to fully respond, based on investigator judgment, to a previously administered adequate course of amphetamine therapy.
Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.

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Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
Subject has a blood pressure measurement ≥95th percentile for age, sex, and height at the Screening Visit (Visit -1) or the Baseline Visit (Visit 0).
Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems placing them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
Subject has any clinically significant electrocardiogram at the Screening Visit (Visit -1) or the Baseline Visit (Visit 0) or clinically significant laboratory abnormalities at the Screening Visit (Visit -1) based on investigator judgment.
Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone and thyroxine at the Screening Visit (Visit -1). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
Subject has a current diagnosis of adjustment disorder, autism, psychosis, or bipolar disorder.
Subject is currently considered at risk for suicide in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded, based on the assessment of the investigator.
Subject has a height ≤5th percentile for age and sex at the Screening Visit (Visit -1).
Subject has a weight ≤5th percentile for age and sex at the Screening Visit (Visit -1).
Subject has a history of seizures (other than infantile febrile seizures) or a current diagnosis of Tourette's disorder.
Subject has a chronic or current tic disorder that is judged by the investigator to be exclusionary.
Subject is taking any medication that is excluded.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Kennedy Krieger Institute
Baltimore, Maryland, 21205
University of Cincinnati
Cincinnati, Ohio, 45219
Duke Child and Family Center
Durham, North Carolina, 27710
Houston Clinical Trials, LLC
Houston, Texas, 77098
Center For Psychiatry and Behavioral Medicine In
Las Vegas, Nevada, 89128
AVIDA
Newport Beach, California, 92660

Other trials in United States

About this study

Official title: A Phase 2, Open-label, Multicenter, Exploratory Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Being tested: SPD489
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.

SPD489Drug
Also called Lisdexmfetamine dimesylate
All subjects will begin with 5mg of SPD489 daily and will be titrated until optimal dose is reached (5, 10, 15, 20, and 30mg)

Study groups in NCT02402166
Study group	Role	What they receive
Single Arm	Experimental	There are 4 periods in this study: 1)screening and washout; 2) Dose Optimization; 3) Dose Maintenance; 4) Safety Follow-up. SPD489 will be used to treat all subjects. Receives: Drug: SPD489

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) at the Specified Dose Level
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment-emergent if it had a start date on or after, or had a start date before but increased in severity after the first dose of investigational product.
Measured: From start of study treatment up to safety follow-up (Week 9)
Change in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire at Week 8 / End of Treatment (ET)
Children's Sleep Habits Questionnaire is a tool designed to screen the most common sleep problems in children, and consists of 33 items for scoring. The instrument evaluates the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night walkings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, daytime sleepiness: 8 to 24, and total disturbance (items from all scales): 33 to 99.
Measured: Baseline, Week 8/ET
Number of Participants With Suicide Related Behavior Assessed by Columbia-Suicide Severity Rating Scale Questionnaire (C-SSRS)
The C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was "yes," the clinician asked questions 3-5. Active suicidal ideation included any participant who answered "yes" to questions 2-5. If the answers to ideation questions 1 and 2 were "No," then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide.
Measured: Baseline, Week 8/ET

Secondary outcomes (3)

Change From Baseline in Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Preschool Version Total Score at FoTA (Final on Treatment Assessment)
The ADHD-RS-IV Preschool Version is an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV-TR) criteria. Each item is scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Data presented here was analysed at Final on-Treatment Assessment (FoTA).
Measured: Baseline, FoTA
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)
CGI-I was performed to rate the severity of a participant's condition on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse). Data presented here was analysed at Final on-Treatment Assessment (FoTA). Improved is defined as a score of "very much improved" or "much improved".
Measured: FoTA
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-last) of SPD489 in Plasma
AUC 0-last is the area under the concentration-time curve from time zero to the time of the last quantifiable concentration of SPD489 in plasma. Pharmacokinetic (PK) parameters were compared against the study NRP104-201 (NCT00557011) to observe and compare the effects of SPD489.
Measured: Visit 7 [Dose Maintenance Phase] at pre-dose, and 1, 2, 3, 4, 6, and 8 h post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 201530 Jun 2016

First posted30 Mar 2015 (estimated)
Study start15 Apr 2015
Primary completion30 Jun 2016
Study completion30 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02402166
Sponsor's protocol ID: SPD489-211
Status last verified: May 2021
First submitted: 19 Mar 2015
Last updated: 8 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

Childress AC, Findling RL, Wu J, Kollins SH, Wang Y, Martin P, Robertson B. Lisdexamfetamine Dimesylate for Preschool Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2020 Apr;30(3):128-136. doi: 10.1089/cap.2019.0117. Epub 2020 Feb 11.
PubMed 32233956

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Conduct Disorder
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All Attention Deficit Hyperactivity Disorder (ADHD) trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Open-label, Multicenter, Exploratory Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder
ClinicalTrials.gov ID: NCT02402166
Acronym / sponsor ID: SPD489-211
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 15 Apr 2015 (actual)
Primary completion: 30 Jun 2016 (actual)
Study completion: 30 Jun 2016 (actual)
First posted: 30 Mar 2015 (estimated)
Results: Posted 25 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Experimental	Drug: SPD489There are 4 periods in this study: 1)screening and washout; 2) Dose Optimization; 3) Dose Maintenance; 4) Safety Follow-up. SPD489 will be used to treat all subjects.

Who may qualify

Ages: 4 to 5 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

Subject is a male or female aged 4-5 years inclusive at the time of consent. Only recruiting male subjects as of December 2015
Subject's parent or LAR must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject in accordance with the ICH GCP Guideline E6 (1996) and applicable regulations, before completing any study-related procedures.
Subject and parent/LAR are willing and able to comply with all of the testing and requirements defined in the protocol, including oversight of morning dosing. Specifically, the same parent/LAR should be available daily to dispense the dose of investigational product for the study duration.
Subject must meet DSM-IV-TR criteria for a primary diagnosis of ADHD (all subtypes) based on a detailed psychiatric evaluation conducted by a sponsor-approved clinician
Subject has an ADHD-RS-IV Preschool Version total score ≥93rd percentile at the Baseline Visit (Visit 0). For boys, this is a score of ≥32. For girls, this is a score of ≥24.

Key exclusion criteria (18 listed)

Subject is required to or anticipates the need to take medications that have CNS effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are taking monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary.
Subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the Screening Visit (Visit -1).
Subject is well controlled on his/her current ADHD medication with acceptable tolerability.
Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that, in the investigator's opinion, would prohibit the subject from completing the study or would not be in the best interest of the subject. The additional conditions would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
Subject has failed to fully respond, based on investigator judgment, to a previously administered adequate course of amphetamine therapy.

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
SPD489Also: Lisdexmfetamine dimesylateAll subjects will begin with 5mg of SPD489 daily and will be titrated until optimal dose is reached (5, 10, 15, 20, and 30mg)	Drug	Single Arm

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (TEAEs) at the Specified Dose Level
Time frame: From start of study treatment up to safety follow-up (Week 9)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment-emergent if it had a start date on or after, or had a start date before but increased in severity after the first dose of investigational product.
Change in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire at Week 8 / End of Treatment (ET)
Time frame: Baseline, Week 8/ET
Children's Sleep Habits Questionnaire is a tool designed to screen the most common sleep problems in children, and consists of 33 items for scoring. The instrument evaluates the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night walkings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, daytime sleepiness: 8 to 24, and total disturbance (items from all scales): 33 to 99.
Number of Participants With Suicide Related Behavior Assessed by Columbia-Suicide Severity Rating Scale Questionnaire (C-SSRS)
Time frame: Baseline, Week 8/ET
The C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was "yes," the clinician asked questions 3-5. Active suicidal ideation included any participant who answered "yes" to questions 2-5. If the answers to ideation questions 1 and 2 were "No," then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide.

3 secondary outcomes

Change From Baseline in Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Preschool Version Total Score at FoTA (Final on Treatment Assessment)
Time frame: Baseline, FoTA
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)
Time frame: FoTA
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-last) of SPD489 in Plasma
Time frame: Visit 7 [Dose Maintenance Phase] at pre-dose, and 1, 2, 3, 4, 6, and 8 h post-dose

Results and safety

Results posted to the registry on 25 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SPD489	24	19

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (TEAEs) at the Specified Dose Level

Time frame: From start of study treatment up to safety follow-up (Week 9). Count of participants. Unit: Participants

Measure	SPD489 5 mg n = 24	SPD489 10 mg n = 23	SPD489 15 mg n = 18	SPD489 20 mg n = 12	SPD489 30 mg n = 10	SPD489 n = 24
Value	10	11	7	6	6	19

Population analysed: Safety analysis set consisted of all participants who had taken at least 1 dose of investigational product. Reporting groups are defined by the dose taken prior to the onset of the TEAE (Treatment Emergent Adverse Event). Number of participants analysed (N) are specific to the reporting group at the specific dose level.

Primary outcome: Change in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire at Week 8 / End of Treatment (ET)

Time frame: Baseline, Week 8/ET. Mean (Standard Deviation). Unit: Units on a Scale

Measure	SPD489 n = 24
Baseline : Bedtime resistance	9.9 (3.58)
Week 8/ End of Treatment (ET) : Bedtime resistance	9.5 (3.26)
Baseline : Sleep-onset delay	1.9 (0.85)
Week 8/ ET : Sleep-onset delay	1.8 (0.92)
Baseline : Sleep duration	4.5 (1.56)
Week 8/ET : Sleep duration	4.0 (1.27)
Baseline : Sleep anxiety	6.6 (2.52)
Week 8/ET : Sleep anxiety	5.5 (1.79)

Population analysed: Safety analysis set consisted of all participants who had taken at least 1 dose of investigational product. Here number of participant analysed for the each sub-scale is specified for this endpoint.

Primary outcome: Number of Participants With Suicide Related Behavior Assessed by Columbia-Suicide Severity Rating Scale Questionnaire (C-SSRS)

Time frame: Baseline, Week 8/ET. Count of participants. Unit: Participants

Measure	SPD489 n = 24
Value	1

Population analysed: Safety analysis set consisted of all participants who had taken at least 1 dose of investigational product.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Start of Treatment up to Safety Follow up (Week 9). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SPD489 5mg	0 of 24 (0%)	6 of 24 (25%)	0 of 24
SPD489 10mg	0 of 23 (0%)	7 of 23 (30.4%)	0 of 23
SPD489 15mg	0 of 18 (0%)	7 of 18 (38.9%)	0 of 18
SPD489 20mg	0 of 12 (0%)	6 of 12 (50%)	0 of 12
SPD489 30mg	0 of 10 (0%)	6 of 10 (60%)	0 of 10
SPD489	0 of 24 (0%)	15 of 24 (62.5%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32233956Childress AC, Findling RL, Wu J, Kollins SH, Wang Y, Martin P, Robertson B. Lisdexamfetamine Dimesylate for Preschool Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2020 Apr;30(3):128-136. doi: 10.1089/cap.2019.0117. Epub 2020 Feb 11.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Related trials for Attention Deficit Hyperactivity Disorder (ADHD)

Enrolling by invitationPhase 3
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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

6 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 SPD489 in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 6 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 10 inclusion and 18 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 8 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 6 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?

Yes. Results are posted in the registry (first posted 25 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) at the Specified Dose Level (time frame: From start of study treatment up to safety follow-up (Week 9)). The study lists 3 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 NCT02402166, 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 8 Jun 2021.