Non-24-Hour Sleep-Wake DisorderPhase 3NCT01430754
Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder
A Phase 3 study testing tasimelteon in people with Non-24-Hour Sleep-Wake Disorder, run by Vanda Pharmaceuticals at 22 sites in United States.
Trial summary
The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-24-Hour Sleep-Wake Disorder
- What is being tested?
- tasimelteon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 22 sitesUnited States
- Study dates
- Sep 2011to Dec 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ability and acceptance to provide informed consent;
- Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without menses for 6 months before screening), or females of child-bearing potential using an acceptable method of birth control for a period of 35 days before the first dosing and must have a negative pregnancy test at the screening and baseline visits; Note: Women using hormonal methods of birth control must use an additional method of birth control during the study and for one month after the last dose.
- Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study;
- Diagnosis of N24HSWD in a previous clinical trial as measured by a tau value of > 24.1 and the lower bound of the 95% CI is > 24.
Who cannot join
- History (within the 12 months prior to screening) of psychiatric disorders including Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder, that is not being successfully treated or has not been resolved and that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures;
- History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;
- History of drug or alcohol abuse as defined in DSM-IV, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening and/or regular consumption of alcoholic drinks (> 2 drinks/day or > 14 drinks/week);
- Note: A standard drink is equal to 13.7 grams (0.6 ounces) of pure alcohol or
- 12-ounces of beer
- 8-ounces of malt liquor
Show all 21Show fewer
- 5-ounces of wine
- 1.5-ounces or a "shot" of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey);
- Subject is at risk of suicide, in the opinion of the Investigator. Evidence of suicide risk could include any suicide attempt within the past year or any other suicidal behavior within the past year;
- Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
- Subjects who have estimated creatinine clearance (CLcr; based on the Cockcroft-Gault equation) ≤ to 55 mL/min;
- Clinically significant deviation from normal in clinical laboratory results, vital signs measurements, or physical examination findings at screening as determined by the clinical investigator;
- Indication of impaired liver function (values for AST, ALT or bilirubin > 2 times Upper Limit of Normal);
- Pregnant or lactating females;
- A positive test for drugs of abuse at the screening visit; Note: A positive drug screen at Visit 1 needs to be discussed with the medical monitor and will be evaluated on a case-by-case basis.
- Smoke more than 10 cigarettes/day;
- Worked night, rotating, or split (period of work, followed by break, and then return to work) shift work within 1 month of the screening visit or plan to work these shifts during the study;
- Unwilling or unable to follow the medication restrictions described in Section 8.2., or unwilling or unable to sufficiently wash-out from use of a restricted medication
- Unable to perform calls to the study IVR system to report questionnaire results;
- Any other sound medical reason as determined by the clinical investigator;
- Legal incompetence or limited legal competence, detainment in an institution for official or legal reasons.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Michigan Head-Pain Neurological Institute
Ann Arbor, Michigan, 48104
Sleep Disorders Center Of Georgia
Atlanta, Georgia, 30342
Brigham and Women's Hospital
Boston, Massachusetts, 02115
PAB Clinical Research Inc.
Brandon, Florida, 33511
St. Luke's Sleep Medicine and Research Center (St. Louis Metropolitan Area)
Chesterfield, Missouri, 63017
The Center for Sleep and Wake Disorders (Washington, D.C. Metropolitan Area)
Chevy Chase, Maryland, 20815
SleepMed, Inc. - Columbia
Columbia, South Carolina, 29201
Radiant Research - Denver
Denver, Colorado, 80239
Ohio Sleep Medicine Institute (Columbus Metropolitan Area)
Dublin, Ohio, 43017
Suburban Lung Associates SC
Elk Grove Village, Illinois, 60007
Todd J. Swick, M.D., P.A.
Houston, Texas, 77063
Mercy Fitzgerald Hospital - Sleep Disorders Center (Philadelphia Metropolitan Area)
Lafayette Hill, Pennsylvania, 19444
Kendall South Medical Center, Inc.
Miami, Florida, 33175
New York Eye and Ear Infirmary
New York, New York, 10003
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
SDS Clinical Trials Inc.
Orange, California, 92868
Ocean Sleep Disorders Center - Ormond Beach
Ormond Beach, Florida, 32174
VA Palo Alto Health Care System/PAIRE (San Fransisco Bay Area)
Palo Alto, California, 94304
Pulmonary Associates, PA
Phoenix, Arizona, 85006
Consolidated Clinical trials
Pittsburgh, Pennsylvania, 15221
Columbia Research Group Inc.
Portland, Oregon, 97239
St. Johns Sleep Disorder Center - St. Johns Medical Plaza
Santa Monica, California, 90404
About this study
Official title: A Randomized Withdrawal Study to Demonstrate the Maintenance of Effect of 20 mg Tasimelteon in the Treatment of N24HSWD
The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.
Read the detailed description
Non-24-Hour Sleep-Wake Disorder (N24HSWD) occurs when individuals are unable to synchronize their endogenous circadian pacemaker to the 24-hour light-dark cycle, and the timing of their circadian rhythm instead reflects the intrinsic period of their endogenous circadian pacemaker. As a result, the circadian rhythm of sleep-wake propensity in these individuals moves gradually later and later each day if there circadian period is > 24 hours and earlier and earlier is < 24 hours. These individuals will be able to sleep well at night when their sleep-wake propensity rhythm is approximately aligned with the 24-hour light-dark and social cycle. However, after a short time, the endogenous sleep-wake propensity rhythm and the 24-hour light-dark cycle will move out of synchrony with each other, and they may have difficulty falling asleep until well into the night. In addition to problems sleeping at the desired time, the subjects experience daytime sleepiness and daytime napping. As time progresses, the endogenous circadian rhythm of sleep-wake propensity in these individuals moves further and further away from the 24-hour light-dark cycle and gradually, these individuals are unable to sleep at night and as a result experience extreme sleepiness during the daytime hours and more frequent naps with a longer duration. Eventually, the sleep-wake time moves back into alignment with the social time for sleep and the individuals sleep well at night and have decreased daytime napping. The alignment between their endogenous circadian rhythms and the 24-hour day is temporary as they are continually drifting later and later each day.
This will be a multicenter, randomized withdrawal, double-masked, placebo-controlled, parallel study. The study has three phases: the tasimelteon run-in phase, the tau estimation phase, and the randomized withdrawal phase. Subjects who have participated in study VP-VEC-162-3201 that meet the entry criteria for this study will be eligible for the run-in phase The run-in phase comprises a screening visit where subject's initial eligibility will be evaluated. Subjects that meet the inclusion/exclusion criteria at screening will enter the run-in phase and will be dosed with 20 mg of tasimelteon daily for 6 weeks. The tau estimation phase (48 hour urine collection samples to evaluate response to tasimelteon) will follow the run-in phase and will last approximately 6 weeks long. The randomized withdrawal phase comprises approximately eight weeks of treatment with either placebo or tasimelteon 20 mg taken approximately 1 hour prior to their target bedtime in a double-masked fashion.
- Conditions
- Non-24-Hour Sleep-Wake Disorder
- Being tested
- tasimelteon, Placebo
- Keywords
- Blindness, Eye Diseases, Nap Disorders, Circadian Rhythm Disorders, Sleep Disorders, Circadian Rhythm Sleep Disorders, Dyssomnias, Nervous System Diseases
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Blindness, Eye Diseases, Chronobiology Disorders, Sleep Wake Disorders, Dyssomnias, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tasimelteonDrug
Also called VEC-162
20 mg tasimelteon capsules, daily
PlaceboDrug
Placebo capsules, daily
| Study group | Role | What they receive |
|---|---|---|
| tasimelteon | Experimental | 20 mg tasimelteon capsules Receives: Drug: tasimelteon |
| Placebo | Placebo comparator | Placebo capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.
Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI >24.0.
Measured: Approximately 12 weeks
Secondary outcomes (5)
Maintenance of Entrainment (Cortisol) in Subjects With N24HSWD
Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary cortisol collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI >24.0.
Measured: Approximately 12 weeks
Change From Run-In in Subjective Nighttime Total Sleep Time in Lower Quartile of Days (LQ-nTST) During the Randomized Phase
LQ-nTST measures the average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) from run-in and randomized phase. The higher number indicates improvement.
Measured: Approximately 12 weeks
Change From Run-In in Total Daytime Sleep Duration in Lower Quartile of Days (UQ-dTSD) During the Randomized Phase
UQ-dTSD measures the average daytime sleep during the patient's worst 25% of days (longest total daytime sleep) from run-in and randomized phase. Lower number indicates improvement.
Measured: Approximately 12 weeks
Change From Run-In in Midpoint of Sleep (MoST) During the Randomized Phase
Midpoint of Sleep Timing (MoST) is the measurement of the average timing of sleep relative to bedtime. The average MoST value will trend to 0 as an individual's sleep becomes more fragmented. Improvement is defined as an increase in the average.
Measured: Approximately 12 weeks
Change From Run-In in Circadian Time to Relapse During the Randomized Phase
Time to relapse is defined as a 45 minute or greater decrement in the weekly average of subjective nighttime total sleep time (nTST) compared to the Run-in Phase.
Measured: Approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionDec 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 (1)Papers the sponsor has linked to this study.
- Other trials for Non-24-Hour Sleep-Wake DisorderStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vanda Pharmaceuticals, Study director, Vanda Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430754
- Sponsor's protocol ID
- VP-VEC-162-3203
- Status last verified
- Oct 2014
- First submitted
- 30 Aug 2011
- Last updated
- 10 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lockley SW, Dressman MA, Licamele L, Xiao C, Fisher DM, Flynn-Evans EE, Hull JT, Torres R, Lavedan C, Polymeropoulos MH. Tasimelteon for non-24-hour sleep-wake disorder in totally blind people (SET and RESET): two multicentre, randomised, double-masked, placebo-controlled phase 3 trials. Lancet. 2015 Oct 31;386(10005):1754-64. doi: 10.1016/S0140-6736(15)60031-9. Epub 2015 Aug 4.
PubMed 26466871
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Withdrawal Study to Demonstrate the Maintenance of Effect of 20 mg Tasimelteon in the Treatment of N24HSWD
- ClinicalTrials.gov ID
- NCT01430754
- Acronym / sponsor ID
- VP-VEC-162-3203
- Conditions
- Non-24-Hour Sleep-Wake Disorder
- Keywords
- Blindness, Eye Diseases, Nap Disorders, Circadian Rhythm Disorders, Sleep Disorders, Circadian Rhythm Sleep Disorders, Dyssomnias, Nervous System Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Posted 10 Oct 2014
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 evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.
Detailed description
Non-24-Hour Sleep-Wake Disorder (N24HSWD) occurs when individuals are unable to synchronize their endogenous circadian pacemaker to the 24-hour light-dark cycle, and the timing of their circadian rhythm instead reflects the intrinsic period of their endogenous circadian pacemaker. As a result, the circadian rhythm of sleep-wake propensity in these individuals moves gradually later and later each day if there circadian period is > 24 hours and earlier and earlier is < 24 hours. These individuals will be able to sleep well at night when their sleep-wake propensity rhythm is approximately aligned with the 24-hour light-dark and social cycle. However, after a short time, the endogenous sleep-wake propensity rhythm and the 24-hour light-dark cycle will move out of synchrony with each other, and they may have difficulty falling asleep until well into the night. In addition to problems sleeping at the desired time, the subjects experience daytime sleepiness and daytime napping. As time progresses, the endogenous circadian rhythm of sleep-wake propensity in these individuals moves further and further away from the 24-hour light-dark cycle and gradually, these individuals are unable to sleep at night and as a result experience extreme sleepiness during the daytime hours and more frequent naps with a longer duration. Eventually, the sleep-wake time moves back into alignment with the social time for sleep and the individuals sleep well at night and have decreased daytime napping. The alignment between their endogenous circadian rhythms and the 24-hour day is temporary as they are continually drifting later and later each day.
This will be a multicenter, randomized withdrawal, double-masked, placebo-controlled, parallel study. The study has three phases: the tasimelteon run-in phase, the tau estimation phase, and the randomized withdrawal phase. Subjects who have participated in study VP-VEC-162-3201 that meet the entry criteria for this study will be eligible for the run-in phase The run-in phase comprises a screening visit where subject's initial eligibility will be evaluated. Subjects that meet the inclusion/exclusion criteria at screening will enter the run-in phase and will be dosed with 20 mg of tasimelteon daily for 6 weeks. The tau estimation phase (48 hour urine collection samples to evaluate response to tasimelteon) will follow the run-in phase and will last approximately 6 weeks long. The randomized withdrawal phase comprises approximately eight weeks of treatment with either placebo or tasimelteon 20 mg taken approximately 1 hour prior to their target bedtime in a double-masked fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tasimelteon | Experimental | Drug: tasimelteon20 mg tasimelteon capsules |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Ability and acceptance to provide informed consent;
- Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without menses for 6 months before screening), or females of child-bearing potential using an acceptable method of birth control for a period of 35 days before the first dosing and must have a negative pregnancy test at the screening and baseline visits; Note: Women using hormonal methods of birth control must use an additional method of birth control during the study and for one month after the last dose.
- Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study;
- Diagnosis of N24HSWD in a previous clinical trial as measured by a tau value of > 24.1 and the lower bound of the 95% CI is > 24.
Key exclusion criteria (21 listed)
- History (within the 12 months prior to screening) of psychiatric disorders including Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder, that is not being successfully treated or has not been resolved and that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures;
- History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;
- History of drug or alcohol abuse as defined in DSM-IV, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening and/or regular consumption of alcoholic drinks (> 2 drinks/day or > 14 drinks/week);
- Subject is at risk of suicide, in the opinion of the Investigator. Evidence of suicide risk could include any suicide attempt within the past year or any other suicidal behavior within the past year;
- Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
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 |
|---|---|---|
| tasimelteonAlso: VEC-16220 mg tasimelteon capsules, daily | Drug | tasimelteon |
| PlaceboPlacebo capsules, daily | Drug | Placebo |
Primary outcome
Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.
Time frame: Approximately 12 weeks
Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI >24.0.
5 secondary outcomes
Maintenance of Entrainment (Cortisol) in Subjects With N24HSWD
Time frame: Approximately 12 weeks
Change From Run-In in Subjective Nighttime Total Sleep Time in Lower Quartile of Days (LQ-nTST) During the Randomized Phase
Time frame: Approximately 12 weeks
Change From Run-In in Total Daytime Sleep Duration in Lower Quartile of Days (UQ-dTSD) During the Randomized Phase
Time frame: Approximately 12 weeks
Change From Run-In in Midpoint of Sleep (MoST) During the Randomized Phase
Time frame: Approximately 12 weeks
Change From Run-In in Circadian Time to Relapse During the Randomized Phase
Time frame: Approximately 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26466871Lockley SW, Dressman MA, Licamele L, Xiao C, Fisher DM, Flynn-Evans EE, Hull JT, Torres R, Lavedan C, Polymeropoulos MH. Tasimelteon for non-24-hour sleep-wake disorder in totally blind people (SET and RESET): two multicentre, randomised, double-masked, placebo-controlled phase 3 trials. Lancet. 2015 Oct 31;386(10005):1754-64. doi: 10.1016/S0140-6736(15)60031-9. Epub 2015 Aug 4.
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.
Vanda Pharmaceuticals study director
Vanda Pharmaceuticals
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tasimelteon in people with Non-24-Hour Sleep-Wake Disorder, run by Vanda Pharmaceuticals at 22 sites 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 21 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 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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 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 10 Oct 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?
Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD. (time frame: Approximately 12 weeks). 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 NCT01430754, which also lists 1 linked publication.
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 Oct 2014.