Primary InsomniaPhase 3NCT00368056
Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability
A Phase 3 study testing Eszopiclone in people with Primary Insomnia, run by Sumitomo Pharma America, Inc. at 1 site in United Kingdom.
Trial summary
To assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Eszopiclone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2005to Jun 2006
- Phase
- Phase 3
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 55 years inclusive
- In good health as determined by a medical history, ECG, haematology, blood and urine biochemistry and physical examination by the doctor
- Diagnostic and statistical manual of mental disorders, defined primary insomnia
- A body mass index greater than or equal to 18 and less than or equal to 30
- Registered with a general practitioner (GP)
- Hold a full current driving licence for at least one year, and be regular car drivers
Who cannot join
- The use of any other medication during the study with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol. A 7-day washout period is required for any patient currently receiving prescription or non-prescription sleep medication.
- Diagnosed sleep disorder or confirmed symptoms other than primary insomnia (e.g. restless leg syndrome, sleep apnoea)
- Significant history of mental illness, significant drug allergy, malignancy or chronic drug abuse (including alcohol)
- Any subject with known hypersensitivity to any of the study treatments
- A sleep/wake cycle other than primary insomnia (e.g. shift work) liable to prejudice the results of the study
- Pregnant or lactating females, and females of child bearing potential not using effective contraception
Show all 10Show fewer
- Patients who habitually smoke more than 5 cigarettes per day
- Caffeine consumption of more than 5 cups or glasses per day
- History of alcohol or drug dependence or intake of more than the equivalent of 14 units of alcohol per week for females and 21 units per week for males
- Current participation in another clinical trial, or participation in a clinical trial within the last 90 days
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
HPRU Medical Research Centre, University of Surrey
Guildford, Surrey
About this study
Official title: Effects of a Single Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability and Psychomotor/Memory Function in Patients With Primary Insomnia Compared to Placebo
To assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients.
Read the detailed description
The study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 male and female primary insomnia patients. The medications under investigation are eszopiclone and placebo. Patients will receive the study medications and placebo on the evening of Day 2 of each treatment period. Performance will be assessed on Day 3 of each treatment period. Each treatment period will be separated by at least a 7-day washout period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
- Conditions
- Primary Insomnia
- Being tested
- Eszopiclone, Placebo
- 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.
EszopicloneDrug
Also called S-Zopiclone, Lunesta
eszopiclone 3 mg
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | eszopiclone 3 mg Receives: Drug: Eszopiclone |
| 2 | Placebo comparator | Placebo tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
next day performance in a standardised test of car driving
Measured: 9.5 hours post dose
Secondary outcomes (7)
Compensatory Tracking Task (CTT)
Measured: 9.5 hours post dose
Rapid Visual Information Processing (RVIP)
Measured: 9.5 hours post dose
Sternberg's Short-term Memory Scanning task (STM)
Measured: 9.5 hours post dose
Critical Flicker Fusion (CFF)
Measured: 9.5 hours post dose
Digit Symbol Substitution Test (DSST)
Measured: 9.5 hours post dose
Choice Reaction Time (CRT)
Measured: 9.5 hours post dose
Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales
Measured: 9.5 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startApr 2005
- Primary completionJun 2006
- Study completionJun 2006
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368056
- Sponsor's protocol ID
- 190-060
- Status last verified
- Feb 2012
- First submitted
- 23 Aug 2006
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability and Psychomotor/Memory Function in Patients With Primary Insomnia Compared to Placebo
- ClinicalTrials.gov ID
- NCT00368056
- Acronym / sponsor ID
- 190-060
- Conditions
- Primary Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 24 Aug 2006 (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.
To assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients.
Detailed description
The study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 male and female primary insomnia patients. The medications under investigation are eszopiclone and placebo. Patients will receive the study medications and placebo on the evening of Day 2 of each treatment period. Performance will be assessed on Day 3 of each treatment period. Each treatment period will be separated by at least a 7-day washout period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Eszopicloneeszopiclone 3 mg |
| 2 | Placebo comparator | Drug: PlaceboPlacebo tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 18 and 55 years inclusive
- In good health as determined by a medical history, ECG, haematology, blood and urine biochemistry and physical examination by the doctor
- Diagnostic and statistical manual of mental disorders, defined primary insomnia
- A body mass index greater than or equal to 18 and less than or equal to 30
- Registered with a general practitioner (GP)
Key exclusion criteria (10 listed)
- The use of any other medication during the study with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol. A 7-day washout period is required for any patient currently receiving prescription or non-prescription sleep medication.
- Diagnosed sleep disorder or confirmed symptoms other than primary insomnia (e.g. restless leg syndrome, sleep apnoea)
- Significant history of mental illness, significant drug allergy, malignancy or chronic drug abuse (including alcohol)
- Any subject with known hypersensitivity to any of the study treatments
- A sleep/wake cycle other than primary insomnia (e.g. shift work) liable to prejudice the results of the study
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 |
|---|---|---|
| EszopicloneAlso: S-Zopiclone, Lunestaeszopiclone 3 mg | Drug | 1 |
| PlaceboPlacebo tablet | Drug | 2 |
Primary outcome
next day performance in a standardised test of car driving
Time frame: 9.5 hours post dose
7 secondary outcomes
Compensatory Tracking Task (CTT)
Time frame: 9.5 hours post dose
Rapid Visual Information Processing (RVIP)
Time frame: 9.5 hours post dose
Sternberg's Short-term Memory Scanning task (STM)
Time frame: 9.5 hours post dose
Critical Flicker Fusion (CFF)
Time frame: 9.5 hours post dose
Digit Symbol Substitution Test (DSST)
Time frame: 9.5 hours post dose
Choice Reaction Time (CRT)
Time frame: 9.5 hours post dose
Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales
Time frame: 9.5 hours post dose
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 22 Feb 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eszopiclone in people with Primary Insomnia, run by Sumitomo Pharma America, Inc. at 1 site in United Kingdom.
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 10 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 22 Feb 2012. 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 Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
next day performance in a standardised test of car driving (time frame: 9.5 hours post dose). 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 22 Feb 2012.