Primary InsomniaPhase 2NCT00664664
Subjective Study to Assess the Efficacy of APD125 in Patients With Sleep Maintenance Insomnia
A Phase 2 study testing APD125 in people with Primary Insomnia, run by Arena Pharmaceuticals at 1 site in United States.
Trial summary
This study is designed to compare 2 doses of APD125 (20 mg and 40 mg) with placebo in otherwise healthy adults with primary insomnia primarily with complaints of maintaining sleep. Participants will be required to maintain a daily sleep dairy for up to 3 weeks while on study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- APD125
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 744 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Nov 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, ages 18 to 65 years
- Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by patient reported sleep diaries
- 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
- 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.
United States1 site
Arena Pharmaceuticals, Inc
San Diego, California, 92121
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Subjective Study to Assess the Efficacy of APD125 in Patients With Primary Insomnia Characterized by Difficulty Maintaining Sleep
This study is designed to compare 2 doses of APD125 (20 mg and 40 mg) with placebo in otherwise healthy adults with primary insomnia primarily with complaints of maintaining sleep. Participants will be required to maintain a daily sleep dairy for up to 3 weeks while on study.
- Conditions
- Primary Insomnia
- Being tested
- APD125, Placebo
- Keywords
- insomnia, sleep maintenance insomnia, sleep quality, non-restorative sleep, multiple awakenings
- 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
soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks
APD125Drug
soft gelatin capsule, 40 mg, daily dosing for up to 3 weeks
PlaceboDrug
soft gelatin capsule, daily dosing for up to 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | APD125 20 mg Receives: Drug: APD125 |
| 2 | Experimental | APD125 40 mg Receives: Drug: APD125 |
| 3 | Placebo comparator | Matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in subjective number of awakenings after sleep onset (sNAASO)
Measured: During and after 2 weeks of study drug
Secondary outcomes (4)
Change from baseline in subjective total sleep time (sTST)
Measured: During and after 2 weeks on study drug
Change from baseline in subjective wake time after sleep onset (sWASO)
Measured: During and after 2 weeks on study drug
Change in subjective latency to sleep onset (sSLO)
Measured: During and after 2 weeks on study drug
Safety and tolerability as assessed by changes from baseline in adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical laboratory values.
Measured: During and after 2 weeks on study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 744 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arena Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arena CT.gov Administrator, Study director, Arena Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664664
- Sponsor's protocol ID
- APD125-007
- Status last verified
- Dec 2020
- First submitted
- 21 Apr 2008
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Subjective Study to Assess the Efficacy of APD125 in Patients With Primary Insomnia Characterized by Difficulty Maintaining Sleep
- ClinicalTrials.gov ID
- NCT00664664
- Acronym / sponsor ID
- APD125-007
- Conditions
- Primary Insomnia
- Keywords
- insomnia, sleep maintenance insomnia, sleep quality, non-restorative sleep, multiple awakenings
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- Arena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 23 Apr 2008 (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.
This study is designed to compare 2 doses of APD125 (20 mg and 40 mg) with placebo in otherwise healthy adults with primary insomnia primarily with complaints of maintaining sleep. Participants will be required to maintain a daily sleep dairy for up to 3 weeks while on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: APD125APD125 20 mg |
| 2 | Experimental | Drug: APD125APD125 40 mg |
| 3 | Placebo comparator | Drug: PlaceboMatching Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women, ages 18 to 65 years
- Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by patient reported sleep diaries
- Generally good health
Key exclusion criteria (7 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 |
|---|---|---|
| APD125soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks | Drug | 1 |
| APD125soft gelatin capsule, 40 mg, daily dosing for up to 3 weeks | Drug | 2 |
| Placebosoft gelatin capsule, daily dosing for up to 3 weeks | Drug | 3 |
Primary outcome
Change from baseline in subjective number of awakenings after sleep onset (sNAASO)
Time frame: During and after 2 weeks of study drug
4 secondary outcomes
Change from baseline in subjective total sleep time (sTST)
Time frame: During and after 2 weeks on study drug
Change from baseline in subjective wake time after sleep onset (sWASO)
Time frame: During and after 2 weeks on study drug
Change in subjective latency to sleep onset (sSLO)
Time frame: During and after 2 weeks on study drug
Safety and tolerability as assessed by changes from baseline in adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical laboratory values.
Time frame: During and after 2 weeks on study drug
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 24 Dec 2020.
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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.
Arena CT.gov Administrator 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 Primary 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 3 inclusion and 7 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 24 Dec 2020. 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?
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?
Change from baseline in subjective number of awakenings after sleep onset (sNAASO) (time frame: During and after 2 weeks of study drug). 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 24 Dec 2020.