InsomniaPhase 2NCT00452179
Safety and Efficacy Study of APD125 in Patient With Insomnia
A Phase 2 study testing APD125 in people with Insomnia, run by Arena Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia
- What is being tested?
- APD125
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2007
- 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 64 years
- All sexes
- Adult
Who may be able to join
- Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by PSG
- PSQI >/= to 5
- Qualifying screening PSG parameters
- Generally good health
Who cannot join
- History of any sleep disorder, other than primary insomnia (e.g., restless leg syndrome, narcolepsy, sleep apnea, and disorders of REM/NREM sleep)
- Any clinically significant medical condition, laboratory finding, or ECG finding
- Pregnant and/or lactating females
- History of substance abuse within 2 years or positive urine drug screen
- Positive Hepatitis B/C results or HIV markers
- Apnea-Hypopnea Index (AHI) or a Periodic Limb Movement Arousal Index (PLMAI) > 10 as determined by screening PSG
- History of treatment with an investigational drug within the last month
- Recent travel involving crossing more than 3 time zones or plans to travel to another time zone (> 3 time zones) during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Effects of APD125 in Patients With Chronic Primary Insomnia
The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia.
- Conditions
- Insomnia
- Being tested
- APD125
- Keywords
- Sleep maintenance, Insomnia, Sleep Consolidation, Sleep, Insomnia, primarily sleep maintenance
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APD125Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Conventional PSG parameters
Secondary outcomes (1)
Patient reported subjective sleep parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2007 (estimated)
- Study startFeb 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arena Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Warren A Prosser, Study director, Arena Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452179
- Sponsor's protocol ID
- APD125-004
- Status last verified
- Sep 2007
- First submitted
- 23 Mar 2007
- Last updated
- 10 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Effects of APD125 in Patients With Chronic Primary Insomnia
- ClinicalTrials.gov ID
- NCT00452179
- Acronym / sponsor ID
- APD125-004
- Conditions
- Insomnia
- Keywords
- Sleep maintenance, Insomnia, Sleep Consolidation, Sleep, Insomnia, primarily sleep maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Arena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 27 Mar 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 the effects of APD125 in patients with sleep maintenance insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by PSG
- PSQI >/= to 5
- Qualifying screening PSG parameters
- Generally good health
Key exclusion criteria (8 listed)
- History of any sleep disorder, other than primary insomnia (e.g., restless leg syndrome, narcolepsy, sleep apnea, and disorders of REM/NREM sleep)
- Any clinically significant medical condition, laboratory finding, or ECG finding
- Pregnant and/or lactating females
- History of substance abuse within 2 years or positive urine drug screen
- Positive Hepatitis B/C results or HIV markers
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 |
|---|---|---|
| APD125 | Drug | – |
Primary outcome
Conventional PSG parameters
1 secondary outcome
Patient reported subjective sleep parameters
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 10 Sep 2007.
- Arena Pharmaceuticals Home PageLink provided by the sponsor.
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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.
Warren A Prosser study director
Arena Pharmaceuticals
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 APD125 in people with Insomnia, run by Arena Pharmaceuticals 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 8 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 10 Sep 2007. 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 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?
Conventional PSG parameters. 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 10 Sep 2007.