Sleep DeprivationPhase 2NCT01096680
Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss
A Phase 2 study testing SPD489 20 mg, SPD489 50 mg and SPD489 70 mg in people with Sleep Deprivation, run by Shire at 1 site in United States.
Trial summary
This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- SPD489 20 mg, SPD489 50 mg and SPD489 70 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2010to 18 Jul 2010
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects between the ages of 18-40 years.
- The subject is in good health and must have a satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history, physical examination, electrocardiogram (ECG), clinical laboratory evaluation (hematology, biochemistry, and urinalysis).
- Subject has a history of regular sleep-wake habits, routinely spending 6.5-8 hours in bed nightly, and does not oversleep by more than 3 hours on weekends.
- Subject has the ability to provide written, signed, and dated (personally) informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practice Guideline E6 and applicable regulations, before completing any study-related procedures.
Who cannot join
- Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make this subject unlikely to fully complete the study, or any condition that presents undue risk from SPD489 or armodafinil or procedures. Comorbid psychiatric diagnosis will be established by a psychiatric evaluation that includes the Mini International Neuropsychiatric Interview (MINI)-Plus.
- Subject is currently considered a suicide risk, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating suicidal ideation.
- Subject has a known or suspected sleep disorder, or another disorder associated with excessive daytime sleepiness, or any other diagnosis that would interfere with assessing sleepiness in subjects with study related induced sleepiness or abnormal findings on the initial PSG conducted on Day -1 such as, but not limited to, Apnea-Hypopnea Index (AHI) or Periodic Limb Movement Arousal Index (PLMAI) >10.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Double-Blind, Single Center, Parallel Group, Placebo and Active Comparator, Controlled Study to Evaluate the Pharmacodynamic Profile of Single Doses of SPD489 in Healthy Adult Male Subjects Undergoing a Nocturnal Period of Acute Sleep Loss
This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.
- Conditions
- Sleep Deprivation
- Being tested
- SPD489 20 mg, SPD489 50 mg, SPD489 70 mg, Armodafinil, Placebo
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPD489 20 mgDrug
Also called Vyvanse
Single oral dose of 20 mg
SPD489 50 mgDrug
Also called Vyvanse
Single oral dose of 50 mg
SPD489 70 mgDrug
Also called Vyvanse
Single oral dose of 70 mg
ArmodafinilDrug
Single oral dose of 250 mg
PlaceboDrug
Single oral dose
| Study group | Role | What they receive |
|---|---|---|
| SPD489 20 mg | Experimental | Not described Receives: Drug: SPD489 20 mg |
| SPD489 50 mg | Experimental | Not described Receives: Drug: SPD489 50 mg |
| SPD489 70 mg | Experimental | Not described Receives: Drug: SPD489 70 mg |
| Armodafinil | Active comparator | Not described Receives: Drug: Armodafinil |
| 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.
Maintenance of Wakefulness Test (MWT)
The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to "stay awake as long as possible" during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better.
Measured: Over a period of 8 hours
Secondary outcomes (4)
Karolinska Sleepiness Scale (KSS) Scores
The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.
Measured: Over a period of 15 hours
KSS Scores by Timepoint
The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.
Measured: Over a period of 15 hours
Psychomotor Vigilance Task (PVT) Scores
PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.
Measured: Over a period of 12 hours
PVT Scores by Timepoint
PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.
Measured: Over a period of 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study start5 Apr 2010
- Primary completion18 Jul 2010
- Study completion18 Jul 2010
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.
- Other trials for Sleep DeprivationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 135 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
- NCT01096680
- Sponsor's protocol ID
- SPD489-207
- Status last verified
- Jun 2021
- First submitted
- 30 Mar 2010
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Single Center, Parallel Group, Placebo and Active Comparator, Controlled Study to Evaluate the Pharmacodynamic Profile of Single Doses of SPD489 in Healthy Adult Male Subjects Undergoing a Nocturnal Period of Acute Sleep Loss
- ClinicalTrials.gov ID
- NCT01096680
- Acronym / sponsor ID
- SPD489-207
- Conditions
- Sleep Deprivation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2010 (actual)
- Primary completion
- 18 Jul 2010 (actual)
- Study completion
- 18 Jul 2010 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Posted 23 Jun 2011
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 double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SPD489 20 mg | Experimental | Drug: SPD489 20 mg |
| SPD489 50 mg | Experimental | Drug: SPD489 50 mg |
| SPD489 70 mg | Experimental | Drug: SPD489 70 mg |
| Armodafinil | Active comparator | Drug: Armodafinil |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male subjects between the ages of 18-40 years.
- The subject is in good health and must have a satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history, physical examination, electrocardiogram (ECG), clinical laboratory evaluation (hematology, biochemistry, and urinalysis).
- Subject has a history of regular sleep-wake habits, routinely spending 6.5-8 hours in bed nightly, and does not oversleep by more than 3 hours on weekends.
- Subject has the ability to provide written, signed, and dated (personally) informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practice Guideline E6 and applicable regulations, before completing any study-related procedures.
Key exclusion criteria (3 listed)
- Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make this subject unlikely to fully complete the study, or any condition that presents undue risk from SPD489 or armodafinil or procedures. Comorbid psychiatric diagnosis will be established by a psychiatric evaluation that includes the Mini International Neuropsychiatric Interview (MINI)-Plus.
- Subject is currently considered a suicide risk, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating suicidal ideation.
- Subject has a known or suspected sleep disorder, or another disorder associated with excessive daytime sleepiness, or any other diagnosis that would interfere with assessing sleepiness in subjects with study related induced sleepiness or abnormal findings on the initial PSG conducted on Day -1 such as, but not limited to, Apnea-Hypopnea Index (AHI) or Periodic Limb Movement Arousal Index (PLMAI) >10.
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 |
|---|---|---|
| SPD489 20 mgAlso: VyvanseSingle oral dose of 20 mg | Drug | SPD489 20 mg |
| SPD489 50 mgAlso: VyvanseSingle oral dose of 50 mg | Drug | SPD489 50 mg |
| SPD489 70 mgAlso: VyvanseSingle oral dose of 70 mg | Drug | SPD489 70 mg |
| ArmodafinilSingle oral dose of 250 mg | Drug | Armodafinil |
| PlaceboSingle oral dose | Drug | Placebo |
Primary outcome
Maintenance of Wakefulness Test (MWT)
Time frame: Over a period of 8 hours
The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to "stay awake as long as possible" during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better.
4 secondary outcomes
Karolinska Sleepiness Scale (KSS) Scores
Time frame: Over a period of 15 hours
KSS Scores by Timepoint
Time frame: Over a period of 15 hours
Psychomotor Vigilance Task (PVT) Scores
Time frame: Over a period of 12 hours
PVT Scores by Timepoint
Time frame: Over a period of 12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 2 study testing SPD489 20 mg, SPD489 50 mg and SPD489 70 mg in people with Sleep Deprivation, 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 4 inclusion and 3 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 14 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 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. 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?
Yes. Results are posted in the registry (first posted 23 Jun 2011). 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?
Maintenance of Wakefulness Test (MWT) (time frame: Over a period of 8 hours). 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 14 Jun 2021.