HypersomniaPhase 2NCT01146600
Clarithromycin for the Treatment of Hypersomnia
A Phase 2 study of Hypersomnia and Idiopathic Hypersomnia, run by Lynn Marie Trotti at 1 site in United States.
Trial summary
The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness and sleeping long periods of time (more than 10 hours per night). Sometimes, hypersomnia is caused by a problem with the quality of sleep occurring at night, for instance when nighttime sleep is disrupted by frequent breathing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersomnia, Idiopathic Hypersomnia, Narcolepsy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Sep 2012
- Phase
- Phase 2
- 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
- Hypersomnia (meeting clinical criteria for Idiopathic hypersomnia with or without long sleep time, narcolepsy lacking cataplexy, or symptomatic hypersomnia not meeting ICSD criteria)
- evidence for GABA-related abnormality, as demonstrated by in-house, in vitro assay
- age > 18
- high performance liquid chromatography/liquid chromatography tandem mass spectrometry verification of the absence of exogenous benzodiazepines
Who cannot join
- Contraindications to use of clarithromycin (pregnancy, severe renal impairment, history of QT prolongation, hypomagnesemia, hypokalemia, bradycardia, history of myocardial infarction or cardiomyopathy, myasthenia gravis, age > 70)
- Current use of cisapride, pimozide, astemizole, terfenadine, colchicines, and ergotamine or dihydroergotamine
- Current use of benzodiazepines or benzodiazepine-receptor agonists
- moderate or severe sleep apnea (RDI > 15/hr), severe periodic limb movement disorder (PLMI > 30/hr)
- diagnosis of narcolepsy with cataplexy, as determined by cerebrospinal hypocretin levels
- metabolic disorders such as anemia, severe iron deficiency, B12 deficiency, or hypothyroidism that may explain symptoms of hypersomnia
Trial locations and contacts
1 site in 1 country.
About this study
The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness and sleeping long periods of time (more than 10 hours per night). Sometimes, hypersomnia is caused by a problem with the quality of sleep occurring at night, for instance when nighttime sleep is disrupted by frequent breathing pauses. In other cases, however, hypersomnia occurs even when nighttime sleep is of good quality. These cases of hypersomnia are presumed to be a symptom of brain dysfunction, and so are referred to as hypersomnias of central (i.e., brain) origin.
The causes of most of these central hypersomnias are not known. However, our group has recently identified a problem with the major brain chemical responsible for sedation, known as GABA. In a subset of our hypersomnia patients, there is a naturally-occurring substance that causes the GABA receptor to be hyperactive. In essence, it is as though these patients are chronically medicated with Valium (or Xanax or alcohol, all substances that act through the GABA system), even though they do not take these medications.
Read more
Current treatment of central hypersomnias is limited. For the fraction of cases with narcolepsy, there are FDA-approved, available treatments. However, for the remainder of patients, there are no treatments approved by the FDA. They are usually treated with medications approved for narcolepsy, but sleep experts agree that these medications are often not effective for this group of patients.
Based on our understanding of the GABA abnormality in these patients, we evaluated whether clarithromycin (an antibiotic approved by the FDA for the treatment of infections) would reverse the GABA abnormality. In a test tube model of this disease, clarithromycin does in fact return the function of the GABA system to normal. The investigators have treated a few patients with clarithromycin and most have felt that their hypersomnia symptoms improved with this treatment.
To determine whether clarithromycin is truly beneficial for central hypersomnia, this study will compare clarithromycin to an inactive pill (the placebo). All subjects will receive both clarithromycin and the placebo at different times, and their reaction times and symptoms will be compared on these two treatments to determine if one is superior. If this study shows that clarithromycin is more effective than placebo in the treatment of hypersomnia, it will identify a potential new therapy for this difficult-to-treat disorder.
Read the detailed description
Central hypersomnias are characterized by severe excessive daytime sleepiness despite long sleep periods (>10 hours/night) and the absence of nocturnal sleep pathology. They preferentially affect young adults, may result in loss of employment, and can lead to motor vehicle accidents (1). Despite these health, safety, and quality of life consequences, there are no FDA-approved therapies for several forms of central hypersomnia, including idiopathic hypersomnia (IH). Currently, IH is treated using therapies approved for narcolepsy, despite a lack of clinical trial data and a consensus that treatment response is poor (2). Treatments include traditional psychostimulants (e.g., amphetamine derivatives) as well as wake-promoting agents with unknown mechanisms of action such as modafinil and sodium oxybate. In addition to side effects including high abuse potential, tachycardia, and altered mental status, treatments are often ineffective and substantial residual sleepiness frequently persists despite poly-therapy.
The investigators hypothesize that pathology in the GABA neurotransmitter system, the brain's major inhibitory system, underlies these central hypersomnias. Currently, there are no hypersomnia therapies that are GABA-antagonists. However, the macrolide antibiotic clarithromycin has been shown to have GABA-modulating properties, resulting in the development of insomnia or mania in a subset of patients. Clarithromycin is therefore a potentially viable, promising therapeutic agent for hypersomnia related to positive modulation of the GABAA receptor. Open-label use of clarithromycin in six hypersomnia patients with known (n = 4) or suspected (n = 2) excess GABAA potentiation resulted in marked improvements in vigilance, as measured on the psychomotor vigilance task (PVT) (unpublished data). The investigators therefore propose a pilot, crossover trial comparing clarithromycin to placebo for the treatment of hypersomnia in patients with excess GABAA potentiation. The primary endpoint will be a decrease in PVT reaction time. Secondary endpoints will include a decrease in PVT lapses and changes in Epworth, Stanford, and FOSQ sleep scales. Successful results from this trial would provide early evidence for a more rational and efficacious treatment for hypersomnia that could avoid the potential abuse, toxicities, and treatment failures associated with traditional treatments.
This will be a pilot crossover trial of clarithromycin and placebo to treat central hypersomnia. Subjects who are untreated for hypersomnia or who experience persistent symptoms despite traditional therapies will be eligible. Subjects who are on medication for hypersomnia at the beginning of the study will be asked to maintain stable doses of these medications for one month before and throughout the study period. Twenty subjects will be assessed at baseline and one and two weeks after being on each study drug (clarithromycin 500 mg bid and matched placebo bid). After two weeks on study drug, they will undergo a one week washout period, then change to the other study drug for an additional two weeks. Patients will be randomized to order of presentation of study drugs such that ten subjects will be randomized to each group. Random sequence generation will be performed our pharmacy. All study investigators and subjects will remain blinded to group assignment.
- Conditions
- Hypersomnia, Idiopathic Hypersomnia, Narcolepsy
- Being tested
- Clarithromycin followed by placebo, Placebo then Clarithromycin
- Keywords
- Primary hypersomnia, CNS hypersomnia, hypersomnia, idiopathic hypersomnia, clarithromycin, Narcolepsy without Cataplexy
- Medical subject headings
- Disorders of Excessive Somnolence, Idiopathic Hypersomnia, Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarithromycin followed by placeboDrug
Also called Biaxin
Clarithromycin 500 mg po bid for two weeks, then one week with no medication, then matched placebo po bid for two weeks.
Placebo then ClarithromycinDrug
Also called Biaxin
Matched placebo po bid for two weeks, then one week with no intervention, then clarithromycin 500 mg po bid for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Random Group A | Experimental | Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups. Receives: Drug: Clarithromycin followed by placebo |
| Random Group B | Experimental | Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups. Receives: Drug: Placebo then Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor Vigilance Task (PVT) Reaction Time
Median reaction time on the PVT at the end of the second week of treatment. Lower values reflect faster reaction times (I.e., greater vigilance).
Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 2, placebo week 2)
Measured: week 2 of each intervention
Secondary outcomes (6)
PVT Median Reaction Time at Week 1
median reaction time on the PVT at week 1 of each intervention. Lower values reflect faster reaction times (i.e., better vigilance)
Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 1, placebo week 1)
Measured: week 1
PVT Number of Lapses
Number of lapses (no response for > 500 msec) on the PVT, averaged by subject across all administrations for a given drug condition (i.e. administered twice at baseline, four times on clarithromycin (twice during week 1 and twice during week 2), and four times on placebo (twice during week 1 and twice during week 2)). Higher numbers indicate worse vigilance.
Measured: baseline, then after 1 week and 2 weeks on each study drug
Epworth Sleepiness Scale
Scores on the Epworth Sleepiness Scale (ESS) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).
ESS scores can range from 0 to 24. Higher scores indicate higher levels of sleepiness.
Measured: baseline, then after 1 week and 2 weeks on each study drug
FOSQ
Scores on the Functional Outcomes of Sleep Questionnaire (FOSQ) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).
Scores on the FOSQ can range from 5 to 20. Higher FOSQ scores indicate less impairment due to sleepiness.
Measured: baseline, then after 1 week and 2 weeks on each study drug
SF-36, Vitality Subscale
The SF-36 is a health outcome scale with multiple subsections. Subjects were administered the entire SF-36; this analysis is of the vitality subscore provided by this scale. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered once at baseline, twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).
The vitality subscore is calculated using four questions from the SF-36, and can range from 0 to 100. Higher scores reflect more vitality.
Measured: baseline, then after 1 week and 2 weeks on each study drug
PSQI
Scores on the Pittsburgh Sleep Quality Index (PSQI), a questionnaire based assessment of sleep quality. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).
Scores on the PSQI can range from 0 to 21. Higher scores indicate poorer sleep quality.
Measured: baseline, then after 1 week and 2 weeks on each study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2012
- Study completionSep 2012
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 (2)Papers the sponsor has linked to this study.
- Other trials for HypersomniaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lynn Marie Trotti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lynn Marie Trotti, Emory University
- Investigators
- Lynn Marie Trotti, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146600
- Sponsor's protocol ID
- IRB00044170
- Status last verified
- Oct 2017
- First submitted
- 15 Jun 2010
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Trotti LM, Becker LA, Friederich Murray C, Hoque R. Medications for daytime sleepiness in individuals with idiopathic hypersomnia. Cochrane Database Syst Rev. 2021 May 25;5(5):CD012714. doi: 10.1002/14651858.CD012714.pub2.
PubMed 34031871Trotti LM, Saini P, Bliwise DL, Freeman AA, Jenkins A, Rye DB. Clarithromycin in gamma-aminobutyric acid-Related hypersomnolence: A randomized, crossover trial. Ann Neurol. 2015 Sep;78(3):454-65. doi: 10.1002/ana.24459. Epub 2015 Jun 30.
PubMed 26094838
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clarithromycin for the Treatment of Hypersomnia
- ClinicalTrials.gov ID
- NCT01146600
- Acronym / sponsor ID
- IRB00044170
- Conditions
- Hypersomnia, Idiopathic Hypersomnia, Narcolepsy
- Keywords
- Primary hypersomnia, CNS hypersomnia, hypersomnia, idiopathic hypersomnia, clarithromycin, Narcolepsy without Cataplexy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Lynn Marie TrottiUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Posted 12 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness and sleeping long periods of time (more than 10 hours per night). Sometimes, hypersomnia is caused by a problem with the quality of sleep occurring at night, for instance when nighttime sleep is disrupted by frequent breathing pauses. In other cases, however, hypersomnia occurs even when nighttime sleep is of good quality. These cases of hypersomnia are presumed to be a symptom of brain dysfunction, and so are referred to as hypersomnias of central (i.e., brain) origin.
The causes of most of these central hypersomnias are not known. However, our group has recently identified a problem with the major brain chemical responsible for sedation, known as GABA. In a subset of our hypersomnia patients, there is a naturally-occurring substance that causes the GABA receptor to be hyperactive. In essence, it is as though these patients are chronically medicated with Valium (or Xanax or alcohol, all substances that act through the GABA system), even though they do not take these medications.
Current treatment of central hypersomnias is limited. For the fraction of cases with narcolepsy, there are FDA-approved, available treatments. However, for the remainder of patients, there are no treatments approved by the FDA. They are usually treated with medications approved for narcolepsy, but sleep experts agree that these medications are often not effective for this group of patients.
Based on our understanding of the GABA abnormality in these patients, we evaluated whether clarithromycin (an antibiotic approved by the FDA for the treatment of infections) would reverse the GABA abnormality. In a test tube model of this disease, clarithromycin does in fact return the function of the GABA system to normal. The investigators have treated a few patients with clarithromycin and most have felt that their hypersomnia symptoms improved with this treatment.
To determine whether clarithromycin is truly beneficial for central hypersomnia, this study will compare clarithromycin to an inactive pill (the placebo). All subjects will receive both clarithromycin and the placebo at different times, and their reaction times and symptoms will be compared on these two treatments to determine if one is superior. If this study shows that clarithromycin is more effective than placebo in the treatment of hypersomnia, it will identify a potential new therapy for this difficult-to-treat disorder.
Detailed description
Central hypersomnias are characterized by severe excessive daytime sleepiness despite long sleep periods (>10 hours/night) and the absence of nocturnal sleep pathology. They preferentially affect young adults, may result in loss of employment, and can lead to motor vehicle accidents (1). Despite these health, safety, and quality of life consequences, there are no FDA-approved therapies for several forms of central hypersomnia, including idiopathic hypersomnia (IH). Currently, IH is treated using therapies approved for narcolepsy, despite a lack of clinical trial data and a consensus that treatment response is poor (2). Treatments include traditional psychostimulants (e.g., amphetamine derivatives) as well as wake-promoting agents with unknown mechanisms of action such as modafinil and sodium oxybate. In addition to side effects including high abuse potential, tachycardia, and altered mental status, treatments are often ineffective and substantial residual sleepiness frequently persists despite poly-therapy.
The investigators hypothesize that pathology in the GABA neurotransmitter system, the brain's major inhibitory system, underlies these central hypersomnias. Currently, there are no hypersomnia therapies that are GABA-antagonists. However, the macrolide antibiotic clarithromycin has been shown to have GABA-modulating properties, resulting in the development of insomnia or mania in a subset of patients. Clarithromycin is therefore a potentially viable, promising therapeutic agent for hypersomnia related to positive modulation of the GABAA receptor. Open-label use of clarithromycin in six hypersomnia patients with known (n = 4) or suspected (n = 2) excess GABAA potentiation resulted in marked improvements in vigilance, as measured on the psychomotor vigilance task (PVT) (unpublished data). The investigators therefore propose a pilot, crossover trial comparing clarithromycin to placebo for the treatment of hypersomnia in patients with excess GABAA potentiation. The primary endpoint will be a decrease in PVT reaction time. Secondary endpoints will include a decrease in PVT lapses and changes in Epworth, Stanford, and FOSQ sleep scales. Successful results from this trial would provide early evidence for a more rational and efficacious treatment for hypersomnia that could avoid the potential abuse, toxicities, and treatment failures associated with traditional treatments.
This will be a pilot crossover trial of clarithromycin and placebo to treat central hypersomnia. Subjects who are untreated for hypersomnia or who experience persistent symptoms despite traditional therapies will be eligible. Subjects who are on medication for hypersomnia at the beginning of the study will be asked to maintain stable doses of these medications for one month before and throughout the study period. Twenty subjects will be assessed at baseline and one and two weeks after being on each study drug (clarithromycin 500 mg bid and matched placebo bid). After two weeks on study drug, they will undergo a one week washout period, then change to the other study drug for an additional two weeks. Patients will be randomized to order of presentation of study drugs such that ten subjects will be randomized to each group. Random sequence generation will be performed our pharmacy. All study investigators and subjects will remain blinded to group assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Random Group A | Experimental | Drug: Clarithromycin followed by placeboSubjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups. |
| Random Group B | Experimental | Drug: Placebo then ClarithromycinSubjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypersomnia (meeting clinical criteria for Idiopathic hypersomnia with or without long sleep time, narcolepsy lacking cataplexy, or symptomatic hypersomnia not meeting ICSD criteria)
- evidence for GABA-related abnormality, as demonstrated by in-house, in vitro assay
- age > 18
- high performance liquid chromatography/liquid chromatography tandem mass spectrometry verification of the absence of exogenous benzodiazepines
Key exclusion criteria (6 listed)
- Contraindications to use of clarithromycin (pregnancy, severe renal impairment, history of QT prolongation, hypomagnesemia, hypokalemia, bradycardia, history of myocardial infarction or cardiomyopathy, myasthenia gravis, age > 70)
- Current use of cisapride, pimozide, astemizole, terfenadine, colchicines, and ergotamine or dihydroergotamine
- Current use of benzodiazepines or benzodiazepine-receptor agonists
- moderate or severe sleep apnea (RDI > 15/hr), severe periodic limb movement disorder (PLMI > 30/hr)
- diagnosis of narcolepsy with cataplexy, as determined by cerebrospinal hypocretin levels
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 |
|---|---|---|
| Clarithromycin followed by placeboAlso: BiaxinClarithromycin 500 mg po bid for two weeks, then one week with no medication, then matched placebo po bid for two weeks. | Drug | Random Group A |
| Placebo then ClarithromycinAlso: BiaxinMatched placebo po bid for two weeks, then one week with no intervention, then clarithromycin 500 mg po bid for two weeks | Drug | Random Group B |
Primary outcome
Psychomotor Vigilance Task (PVT) Reaction Time
Time frame: week 2 of each intervention
Median reaction time on the PVT at the end of the second week of treatment. Lower values reflect faster reaction times (I.e., greater vigilance). Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 2, placebo week 2)
6 secondary outcomes
PVT Median Reaction Time at Week 1
Time frame: week 1
PVT Number of Lapses
Time frame: baseline, then after 1 week and 2 weeks on each study drug
Epworth Sleepiness Scale
Time frame: baseline, then after 1 week and 2 weeks on each study drug
FOSQ
Time frame: baseline, then after 1 week and 2 weeks on each study drug
SF-36, Vitality Subscale
Time frame: baseline, then after 1 week and 2 weeks on each study drug
PSQI
Time frame: baseline, then after 1 week and 2 weeks on each study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34031871Trotti LM, Becker LA, Friederich Murray C, Hoque R. Medications for daytime sleepiness in individuals with idiopathic hypersomnia. Cochrane Database Syst Rev. 2021 May 25;5(5):CD012714. doi: 10.1002/14651858.CD012714.pub2.
- Derived from this study: PubMed 26094838Trotti LM, Saini P, Bliwise DL, Freeman AA, Jenkins A, Rye DB. Clarithromycin in gamma-aminobutyric acid-Related hypersomnolence: A randomized, crossover trial. Ann Neurol. 2015 Sep;78(3):454-65. doi: 10.1002/ana.24459. Epub 2015 Jun 30.
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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.
Lynn Marie Trotti, MD principal investigator
Emory University
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 of Hypersomnia and Idiopathic Hypersomnia, run by Lynn Marie Trotti 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 6 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 6 Nov 2017. 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?
Yes. Results are posted in the registry (first posted 12 Jun 2014). 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?
Psychomotor Vigilance Task (PVT) Reaction Time (time frame: week 2 of each intervention). 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 NCT01146600, which also lists 2 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 6 Nov 2017.