NarcolepsyPhase 3NCT00066170
Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
A Phase 3 study testing Xyrem and Modafinil at established dose in people with Narcolepsy, run by Jazz Pharmaceuticals at 40 sites in 4 countries.
Trial summary
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy
- What is being tested?
- Xyrem and Modafinil at established dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 40 sitesin 4 countries
- Study dates
- Apr 2003to Nov 2004
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be included in the trial if they:
- Have signed and dated an informed consent prior to beginning protocol required procedures.
- Are willing and able to complete the entire trial as described in the protocol.
- Are 18 years of age or older.
- Fulfill the International Classification of Sleep Disorders criteria for the diagnosis of narcolepsy.
- Are taking stable doses of modafinil (200 to 600 mg/day) for the treatment of daytime sleepiness for a period of three months or greater and the modafinil dose has been stable for at least 1 month prior to entering this trial
- Females may be included who are surgically sterile, two years post-menopausal, or if of child-bearing potential, using a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the trial.
- In the opinion of the investigator have adequate support for the duration of the trial to include transportation to and from the trial site. In addition, if in the investigator's assessment it is clinically indicated, the patient is willing to not operate a car or heavy machinery for the duration of the trial or for as long as the investigator deems clinically indicated.
Who cannot join
- Patients will be excluded from the trial if they:
- Have received gamma-hydroxybutyrate in the last 30 days.
- Have taken any investigational therapy within the 30-day period prior to the initial screening visit (Visit 1) for this trial.
- Have sleep apnea syndrome, defined as an Apnea Index > 10 per hour or an AHI (Apnea Hypopnea Index) greater than 15 per hour, or have any other cause of daytime sleepiness, and have any other disorder(s) that can be considered a primary cause of excessive daytime sleepiness (e.g., severe periodic leg movement syndrome as determined by the investigator, sleep apnea, sleep deprivation).
- Are taking hypnotics, tranquilizers, antihistamines (except for non-sedating antihistamines), benzodiazepines or clonidine at the start of the baseline period. Patients taking anticonvulsants are not eligible to participate event if they are willing to washout anticonvulsants for the trial.
- Are experiencing any major illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological (other than narcolepsy/cataplexy), pulmonary, and/or renal disease which would place the patient at risk during the trial or compromise the objectives outlined in the protocol.
Show all 11Show fewer
- Have psychiatric disorders, major affective or psychotic disorders, or other problems that, in the investigator's opinion, would preclude the patient's participation and completion of this trial or compromise reliable representation of subjective symptoms.
- Have a current or recent (within one year) history of a substance use disorder including alcohol abuse as defined by the DSM-IV.
- Have a serum creatinine greater than 2.0 mg/dL, abnormal liver function tests (SGOT [AST] or SGPT [ALT] more than twice the upper limit of normal), or elevated serum bilirubin (more than 1.5 times the upper limit of normal), or pre-trial ECG results demonstrating clinically significant arrhythmias, greater than a first degree AV block or a history of myocardial infarction within the last six months.
- Have an occupation that requires variable shift work or routine night shift.
- Have a clinically significant history of seizure disorder either past or present, a history of clinically significant head trauma (i.e., concussion resulting in clinically significant loss of consciousness) or past invasive intracranial surgery, and are taking anticonvulsant medications.
Trial locations and contacts
40 sites in 4 countries.
40 sites in 4 countries
United States36 sites
Lehigh Valley Hospital Sleep Disorders Center
Allentown, Pennsylvania, 18105
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101
Capital Region Sleep Disorder Center
Carlisle, Pennsylvania, 17013
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina, 29406-7108
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815
Cincinnati Clinic & Sleep Management Institute
Cincinnati, Ohio, 45219
Community Research Management Associates,Inc.
Cincinnati, Ohio, 45219
SleepMed of South Carolina
Columbia, South Carolina, 29220
Community Research & Sleep Management Institute
Crestview Hills, Kentucky, 41017
The Center for Sleep and Wake Disorders/Midwest Neurology
Danville, Indiana, 46122
Henry Ford Hospital
Detroit, Michigan, 48202
New Jersey Neuroscience Institute at JFK Medical Center
Edison, New Jersey, 08818
Sleep Disorders Center -- Union Hospital of Cecil County
Elkton, Maryland, 21921
Vermont Medical Sleep Disorders Center, Inc.
Essex Junction, Vermont, 05452
St. Jude Medical Center -- Sleep Disorders Institute
Fullerton, California, 92835
CSC Research -- Grove City Sleep Diagnostic Center
Grove City, Ohio, 43123
Center for Sleep Medicine
Lafayette Hill, Pennsylvania, 19444
Pacific Sleep Medicine Services, Inc.
Los Angeles, California, 90048
Chest Medicine Associates DBA -- Sleep Medicine Specialists
Louisville, Kentucky, 40217
Bhupesh Dihenia, MD
Lubbock, Texas, 79410
Neuro-Therapeutics, Inc.
Pasadena, California, 91105
Peoria Pulmonary Associates, Ltd
Peoria, Illinois, 61603
Pulmonary Associates, PA
Phoenix, Arizona, 85006
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
Sleep Disorders Center of Rochester
Rochester, New York, 14618
Strong Sleep Disorders Center
Rochester, New York, 14618
SLEEP WALKER -- Sleep Disorders Center & Neurodiagnostics--Lung Diagnostics, Ltd.
San Antonio, Texas, 78229
Pacific Sleep Medicine Services, Inc.
San Diego, California, 92121
SDHRF Clinical Research Center
Sioux Falls, South Dakota, 57104
Sioux Valley Clinic -- Pulmonary
Sioux Falls, South Dakota, 57105
Sleep Disorders Center
Sioux Falls, South Dakota, 57105
Washington University Sleep Center
St Louis, Missouri, 63108
Clinical Research Group of St. Petersburg, Inc.
St. Petersburg, Florida, 33707
Stanford Sleep Disorders Clinic
Stanford, California, 94305
Sleep Medicine Associates of Maryland
Towson, Maryland, 21204
ALL-TRIALS Clinical Research, LLC -- Summit Sleep Disorder
Winston-Salem, North Carolina, 27103
France2 sites
Centre du sommeil -- Hopital Gui de Chauliac
Montpellier, Cedex 5, 34295
Hopital Pitie Salpetriere -- Federation des Pathologies du sommeil
Paris, Cedex 13, 75651
Switzerland1 site
Neurologische Poliklinik -- Universitats Spital Zurich
Zurich, CH-8091
About this study
Official title: Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) and Modafinil With Placebo in Treatment of Daytime Sleepiness in Narcolepsy
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.
- Conditions
- Narcolepsy
- Being tested
- Xyrem, Xyrem Placebo, Modafinil at established dose, Modafinil (Placebo)
- Keywords
- Narcolepsy, Daytime Sleepiness, Daytime sleepiness in narcolepsy
- Medical subject headings
- Narcolepsy, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XyremDrug
Also called Sodium Oxybate
Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
Xyrem PlaceboDrug
Also called Sodium Oxybate Placebo
Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
Modafinil at established doseDrug
Also called Provigil
Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
Modafinil (Placebo)Drug
Also called Provigil Placebo
Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1. | Experimental | Xyrem + Modafinil Placebo Receives: Drug: Xyrem; Drug: Modafinil (Placebo) |
| Group 2: | Placebo comparator | Xyrem Placebo + Modafinil Placebo Receives: Drug: Xyrem Placebo; Drug: Modafinil (Placebo) |
| Group 3 | Active comparator | Xyrem Placebo + Modafinil at established dose Receives: Drug: Xyrem Placebo; Drug: Modafinil at established dose |
| Group 4: | Experimental | Xyrem + Modafinil at established dose Receives: Drug: Xyrem; Drug: Modafinil at established dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)
The Maintenance of Wakefulness Test consisted of four 20 minute tests of the patient's ability to remain awake in soporific conditions. The Mean change from baseline to week 8 in the average MWT number of minutes until sleep onset was the primary endpoint.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2003 (estimated)
- Study startApr 2003
- Primary completionJul 2004
- Study completionNov 2004
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.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yanping Zheng, MD, Study director, Jazz Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066170
- Sponsor's protocol ID
- OMC-SXB-22
- Status last verified
- Dec 2011
- First submitted
- 4 Aug 2003
- Last updated
- 29 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.
PubMed 11833860Scrima L, Hartman PG, Johnson FH Jr, Thomas EE, Hiller FC. The effects of gamma-hydroxybutyrate on the sleep of narcolepsy patients: a double-blind study. Sleep. 1990 Dec;13(6):479-90. doi: 10.1093/sleep/13.6.479.
PubMed 2281247Lammers GJ, Arends J, Declerck AC, Ferrari MD, Schouwink G, Troost J. Gammahydroxybutyrate and narcolepsy: a double-blind placebo-controlled study. Sleep. 1993 Apr;16(3):216-20. doi: 10.1093/sleep/16.3.216.
PubMed 8506453A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.
PubMed 12627729Black J, Houghton WC. Sodium oxybate improves excessive daytime sleepiness in narcolepsy. Sleep. 2006 Jul;29(7):939-46. doi: 10.1093/sleep/29.7.939.
PubMed 16895262Black J, Pardi D, Hornfeldt CS, Inhaber N. The nightly use of sodium oxybate is associated with a reduction in nocturnal sleep disruption: a double-blind, placebo-controlled study in patients with narcolepsy. J Clin Sleep Med. 2010 Dec 15;6(6):596-602.
PubMed 21206549Husain AM, Bujanover S, Ryan R, Scheckner B, Black J, Profant J. Incidence and duration of common, early-onset adverse events occurring during 2 randomized, placebo-controlled, phase 3 studies of sodium oxybate in participants with narcolepsy. J Clin Sleep Med. 2020 Sep 15;16(9):1469-1474. doi: 10.5664/jcsm.8530.
PubMed 32356515Dauvilliers Y, Roth T, Guinta D, Alvarez-Horine S, Dynin E, Black J. Effect of sodium oxybate, modafinil, and their combination on disrupted nighttime sleep in narcolepsy. Sleep Med. 2017 Dec;40:53-57. doi: 10.1016/j.sleep.2017.07.030. Epub 2017 Oct 7.
PubMed 29221779
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) and Modafinil With Placebo in Treatment of Daytime Sleepiness in Narcolepsy
- ClinicalTrials.gov ID
- NCT00066170
- Acronym / sponsor ID
- OMC-SXB-22
- Conditions
- Narcolepsy
- Keywords
- Narcolepsy, Daytime Sleepiness, Daytime sleepiness in narcolepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 6 Aug 2003 (estimated)
- Results
- Posted 30 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1. | Experimental | Drug: Xyrem, Drug: Modafinil (Placebo)Xyrem + Modafinil Placebo |
| Group 2: | Placebo comparator | Drug: Xyrem Placebo, Drug: Modafinil (Placebo)Xyrem Placebo + Modafinil Placebo |
| Group 3 | Active comparator | Drug: Xyrem Placebo, Drug: Modafinil at established doseXyrem Placebo + Modafinil at established dose |
| Group 4: | Experimental | Drug: Xyrem, Drug: Modafinil at established doseXyrem + Modafinil at established dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have signed and dated an informed consent prior to beginning protocol required procedures.
- Are willing and able to complete the entire trial as described in the protocol.
- Are 18 years of age or older.
- Fulfill the International Classification of Sleep Disorders criteria for the diagnosis of narcolepsy.
- Are taking stable doses of modafinil (200 to 600 mg/day) for the treatment of daytime sleepiness for a period of three months or greater and the modafinil dose has been stable for at least 1 month prior to entering this trial
Key exclusion criteria (11 listed)
- Have received gamma-hydroxybutyrate in the last 30 days.
- Have taken any investigational therapy within the 30-day period prior to the initial screening visit (Visit 1) for this trial.
- Have sleep apnea syndrome, defined as an Apnea Index > 10 per hour or an AHI (Apnea Hypopnea Index) greater than 15 per hour, or have any other cause of daytime sleepiness, and have any other disorder(s) that can be considered a primary cause of excessive daytime sleepiness (e.g., severe periodic leg movement syndrome as determined by the investigator, sleep apnea, sleep deprivation).
- Are taking hypnotics, tranquilizers, antihistamines (except for non-sedating antihistamines), benzodiazepines or clonidine at the start of the baseline period. Patients taking anticonvulsants are not eligible to participate event if they are willing to washout anticonvulsants for the trial.
- Are experiencing any major illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological (other than narcolepsy/cataplexy), pulmonary, and/or renal disease which would place the patient at risk during the trial or compromise the objectives outlined in the protocol.
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 |
|---|---|---|
| XyremAlso: Sodium OxybateXyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks. | Drug | Group 1., Group 4: |
| Xyrem PlaceboAlso: Sodium Oxybate PlaceboXyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks. | Drug | Group 2:, Group 3 |
| Modafinil at established doseAlso: ProvigilModafinil oral capsules at 200 to 600 mg per day for 8 weeks. | Drug | Group 3, Group 4: |
| Modafinil (Placebo)Also: Provigil PlaceboModafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks. | Drug | Group 1., Group 2: |
Primary outcome
Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)
Time frame: Baseline to Week 8
The Maintenance of Wakefulness Test consisted of four 20 minute tests of the patient's ability to remain awake in soporific conditions. The Mean change from baseline to week 8 in the average MWT number of minutes until sleep onset was the primary endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11833860A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.
- Background: PubMed 2281247Scrima L, Hartman PG, Johnson FH Jr, Thomas EE, Hiller FC. The effects of gamma-hydroxybutyrate on the sleep of narcolepsy patients: a double-blind study. Sleep. 1990 Dec;13(6):479-90. doi: 10.1093/sleep/13.6.479.
- Background: PubMed 8506453Lammers GJ, Arends J, Declerck AC, Ferrari MD, Schouwink G, Troost J. Gammahydroxybutyrate and narcolepsy: a double-blind placebo-controlled study. Sleep. 1993 Apr;16(3):216-20. doi: 10.1093/sleep/16.3.216.
- Background: PubMed 12627729A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.
- Results publication: PubMed 16895262Black J, Houghton WC. Sodium oxybate improves excessive daytime sleepiness in narcolepsy. Sleep. 2006 Jul;29(7):939-46. doi: 10.1093/sleep/29.7.939.
- Results publication: PubMed 21206549Black J, Pardi D, Hornfeldt CS, Inhaber N. The nightly use of sodium oxybate is associated with a reduction in nocturnal sleep disruption: a double-blind, placebo-controlled study in patients with narcolepsy. J Clin Sleep Med. 2010 Dec 15;6(6):596-602.
- Derived from this study: PubMed 32356515Husain AM, Bujanover S, Ryan R, Scheckner B, Black J, Profant J. Incidence and duration of common, early-onset adverse events occurring during 2 randomized, placebo-controlled, phase 3 studies of sodium oxybate in participants with narcolepsy. J Clin Sleep Med. 2020 Sep 15;16(9):1469-1474. doi: 10.5664/jcsm.8530.
- Derived from this study: PubMed 29221779Dauvilliers Y, Roth T, Guinta D, Alvarez-Horine S, Dynin E, Black J. Effect of sodium oxybate, modafinil, and their combination on disrupted nighttime sleep in narcolepsy. Sleep Med. 2017 Dec;40:53-57. doi: 10.1016/j.sleep.2017.07.030. Epub 2017 Oct 7.
- Xyrem Informational website with the package insertLink provided by the sponsor.
Related trials for Narcolepsy
RecruitingPhase 2/3
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Idiopathic Hypersomnia, Narcolepsy Type 1
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingObservational study
Epidemiology of Narcolepsy Type 1 and Type 2 in Spain
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingPhase 3
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
Not yet recruitingObservational study
A Study About Treatment Use in Adults With Narcolepsy Type 1 (NT1) in Europe and Canada
Narcolepsy Type 1
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.
Yanping Zheng, MD study director
Jazz Pharmaceuticals, Inc
40 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xyrem and Modafinil at established dose in people with Narcolepsy, run by Jazz Pharmaceuticals at 40 sites in 4 countries.
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 8 inclusion and 11 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 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, France, Germany, Switzerland. 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?
Yes. Results are posted in the registry (first posted 30 Nov 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?
Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT) (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00066170, which also lists 8 linked publications.
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 29 Dec 2011; AzTrials last refreshed its copy on 8 Nov 2026.