Sleep DisorderPhase 1NCT01124851
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
A Phase 1 study testing ABT-652 in people with Sleep Disorder, run by Abbott at 5 sites in United States.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652 given once daily to people with excessive daytime sleepiness. Subjects will be randomized to either ABT-652 or placebo in three sequential dosing groups for a 1-week treatment period. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- ABT-652
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2010to Apr 2011
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has current diagnosis of an excessive daytime sleepiness disorder, including narcolepsy, idiopathic hypersomnia, and obstructive sleep apnea
- Age 18 to 60 years Exclusion Criteria
- Has significant suicidal ideation
- Has a history of substance abuse
- Has a history of a certain significant medical conditions, including uncontrolled psychiatric diseases or disorders
- Use of certain medications
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Site Reference ID/Investigator# 38122
Durham, North Carolina, 27710
Site Reference ID/Investigator# 38092
Glendale, California, 91206
Site Reference ID/Investigator# 40402
New York, New York, 10019
Site Reference ID/Investigator# 43241
Phoenix, Arizona, 85006
Site Reference ID/Investigator# 43264
San Diego, California, 92103
About this study
Official title: A Multiple Dose Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ABT-652 Administered Once Daily to Subjects With an Excessive Daytime Sleepiness Disorder
The main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652 given once daily to people with excessive daytime sleepiness. Subjects will be randomized to either ABT-652 or placebo in three sequential dosing groups for a 1-week treatment period.
- Conditions
- Sleep Disorder
- Being tested
- ABT-652, Placebo
- Keywords
- Sleep disorder
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-652Drug
See arm description for details
PlaceboDrug
See arm description for details
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | ABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days Receives: Drug: ABT-652; Drug: Placebo |
| Arm 2 | Experimental | ABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days Receives: Drug: ABT-652; Drug: Placebo |
| Arm 3 | Experimental | ABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days Receives: Drug: ABT-652; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory Tests
Measured: Baseline period to end of 1-week treatment period.
ECG
Measured: Baseline period to end of 1-week treatment period.
Adverse Events
Measured: Baseline period till 30 days after the last dose.
Vital Signs
Measured: Baseline period to end of 1-week treatment period.
Secondary outcomes (1)
Maintenance Wakefulness Test
Measured: Baseline period to end of 1-week treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124851
- Sponsor's protocol ID
- M11-685
- Status last verified
- Jun 2011
- First submitted
- 26 Apr 2010
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ABT-652 Administered Once Daily to Subjects With an Excessive Daytime Sleepiness Disorder
- ClinicalTrials.gov ID
- NCT01124851
- Acronym / sponsor ID
- M11-685
- Conditions
- Sleep Disorder
- Keywords
- Sleep disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 17 May 2010 (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 main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652 given once daily to people with excessive daytime sleepiness. Subjects will be randomized to either ABT-652 or placebo in three sequential dosing groups for a 1-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: ABT-652, Drug: PlaceboABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days |
| Arm 2 | Experimental | Drug: ABT-652, Drug: PlaceboABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days |
| Arm 3 | Experimental | Drug: ABT-652, Drug: PlaceboABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Has current diagnosis of an excessive daytime sleepiness disorder, including narcolepsy, idiopathic hypersomnia, and obstructive sleep apnea
- Age 18 to 60 years Exclusion Criteria
- Has significant suicidal ideation
- Has a history of substance abuse
- Has a history of a certain significant medical conditions, including uncontrolled psychiatric diseases or disorders
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ABT-652See arm description for details | Drug | Arm 1, Arm 2, Arm 3 |
| PlaceboSee arm description for details | Drug | Arm 1, Arm 2, Arm 3 |
Primary outcome
Laboratory Tests
Time frame: Baseline period to end of 1-week treatment period.
ECG
Time frame: Baseline period to end of 1-week treatment period.
Adverse Events
Time frame: Baseline period till 30 days after the last dose.
Vital Signs
Time frame: Baseline period to end of 1-week treatment period.
1 secondary outcome
Maintenance Wakefulness Test
Time frame: Baseline period to end of 1-week treatment period.
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 4 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-652 in people with Sleep Disorder, run by Abbott at 5 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 6 inclusion and 0 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 4 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Laboratory Tests (time frame: Baseline period to end of 1-week treatment period.). The study lists 4 primary outcomes in all. 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 4 Jul 2011.