Non-24-Hour Sleep-Wake DisorderPhase 3NCT01429116
Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception
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 safety of tasimelteon in male and female patients who suffer from Non-24-Hour Sleep-Wake Disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 22 sitesUnited States
- Study dates
- Oct 2011to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and acceptance to provide informed consent;
- Men or women at least 18 years of age or older who meet one of the following:
- Has enrolled in VP-VEC-162-3201 (with sponsor approval)
- Has completed VP-VEC-162-3203
- Was deemed a non-responder in VP-VEC-162-3203
- Has enrolled in VP-VEC-162-3203 (with sponsor approval)
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- Has a previous diagnosis of N24HSWD
- The subject is totally blind and meets the following Diagnostic and Statistical Manual of Mental Disorders 5 diagnostic criteria
- A persistent or recurrent pattern of sleep disruption that is primarily due to an alteration of the circadian system or to a misalignment between the endogenous circadian rhythm and the sleep-wake schedule required by an individual's physical environment or social or professional schedule.
- The sleep disruption leads to excessive sleepiness or insomnia, or both.
- The sleep disturbance causes clinically significant distress or impairment in social, occupational, and other important areas of functioning.
- Specifically: A pattern of sleep-wake cycles that is not synchronized to the 24-hour environment, with a consistent daily drift (usually to later and later times) of sleep onset and wake times.
- For US participants only: 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 during the study and for one month following the last dose 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.
- Diagnosis of N24HSWD in a previous tasimelteon study;
- Willing and able to comply with study requirements and restrictions;
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 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 (> 40g/day);
- Patients having any current suicidal ideation of type 4 or 5 on the C-SSRS at Screening or Baseline;
- Patient 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;
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- Clinically significant deviation from normal in vital signs measurements, or physical examination findings at screening or baseline as determined by the clinical investigator;
- Pregnant or lactating females;
- Smoke more than 10 cigarettes/day;
- Exposure to any investigational drug other than tasimelteon, including placebo, within 30 days, 5 half-lives, or the exclusion period given by a previous study in which the patient has participated in, whichever of the three scenarios is longer.
- Unwilling or unable to discontinue usage of medication listed in Section 8.2.1;
- Any other sound medical reason as determined by the clinical investigator.
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 (Chicago Metropolitan Area)
Elk Grove Village, Illinois, 60007
Todd J. Swick, M.D., P.A.
Houston, Texas, 77063
Kendall South Medical Center, Inc.
Miami, Florida, 33185
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
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174
VA Palo Alto Health Care System/PAIRE (San Fransisco Bay Area)
Palo Alto, California, 94304
Center for Sleep Medicine at Chestnut Hill Hospital
Philadelphia, Pennsylvania, 19118
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: An Extension Open-Label Safety Study of a 24-month 20 mg Dose Regimen of Tasimelteon for the Treatment of Non-24-Hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception Who Have Enrolled in Other Tasimelteon Clinical Trials
The purpose of this study is to evaluate the safety of tasimelteon in male and female patients who suffer 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.
The study is comprised of one 24-month treatment phase, as all subjects enrolled in the trial have already been diagnosed with N24HSWD. Frequency of study visits will depend on the subject's prior length of exposure to tasimelteon; accordingly, subjects will be assigned to one of two groups upon enrollment into the study. The short-term exposure group will consist of subjects for which it is possible at screening that they have been exposed to tasimelteon for less than 6 months. The long-term exposure group will consist of subjects who have more than 6 months of exposure to tasimelteon.
After completion of the 24-month treatment phase, subjects have the option to enroll into the optional open-label extension sub-study for an additional 52 weeks. Frequency of visits will be identical regardless of previous exposure (short term/long term).
- Conditions
- Non-24-Hour Sleep-Wake Disorder
- Being tested
- tasimelteon
- 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, PO daily for 24 months + 12 month optional extension
| Study group | Role | What they receive |
|---|---|---|
| tasimelteon | Experimental | 20 mg tasimelteon capsules, PO daily for 24 months + 12 month optional extension Receives: Drug: tasimelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment-Emergent Adverse Events (AEs)
Treatment-emergent adverse events will be summarized by presenting the number and percentage of patients having any treatment-emergent AE, having an AE in each body system, and having each individual AE.
Measured: 24 months + 12 month optional extension
Secondary outcomes (4)
Number of participants with changes in Clinical Laboratory Data
Standard Serum Hematology and Chemistry tests will be performed at baseline and through the 24 months of treatment
Measured: 24 months + 12 month optional extension
Number of participants with newly occurring or worsening ECG abnormalities
Measured: 24 months + 12 month optional extension
Number of participants with clinically notable Vital Signs and Body Measurements
Measured: 24 months + 12 month optional extension
Number of participants who report a positive result for the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: 24 months + 12 month optional extension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-24-Hour Sleep-Wake DisorderStudies of the same condition, open and under way.
- More trials run by Vanda 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
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
- NCT01429116
- Sponsor's protocol ID
- VP-VEC-162-3204
- Status last verified
- Apr 2015
- First submitted
- 30 Aug 2011
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Open-Label Safety Study of a 24-month 20 mg Dose Regimen of Tasimelteon for the Treatment of Non-24-Hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception Who Have Enrolled in Other Tasimelteon Clinical Trials
- ClinicalTrials.gov ID
- NCT01429116
- Acronym / sponsor ID
- VP-VEC-162-3204
- 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
- 200 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 5 Sep 2011 (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.
The purpose of this study is to evaluate the safety of tasimelteon in male and female patients who suffer 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.
The study is comprised of one 24-month treatment phase, as all subjects enrolled in the trial have already been diagnosed with N24HSWD. Frequency of study visits will depend on the subject's prior length of exposure to tasimelteon; accordingly, subjects will be assigned to one of two groups upon enrollment into the study. The short-term exposure group will consist of subjects for which it is possible at screening that they have been exposed to tasimelteon for less than 6 months. The long-term exposure group will consist of subjects who have more than 6 months of exposure to tasimelteon.
After completion of the 24-month treatment phase, subjects have the option to enroll into the optional open-label extension sub-study for an additional 52 weeks. Frequency of visits will be identical regardless of previous exposure (short term/long term).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tasimelteon | Experimental | Drug: tasimelteon20 mg tasimelteon capsules, PO daily for 24 months + 12 month optional extension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Ability and acceptance to provide informed consent;
- Men or women at least 18 years of age or older who meet one of the following:
- Specifically: A pattern of sleep-wake cycles that is not synchronized to the 24-hour environment, with a consistent daily drift (usually to later and later times) of sleep onset and wake times.
- For US participants only: 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 during the study and for one month following the last dose 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.
- Diagnosis of N24HSWD in a previous tasimelteon study;
Key exclusion criteria (12 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 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 (> 40g/day);
- Patients having any current suicidal ideation of type 4 or 5 on the C-SSRS at Screening or Baseline;
- Patient 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;
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, PO daily for 24 months + 12 month optional extension | Drug | tasimelteon |
Primary outcome
Number of participants with Treatment-Emergent Adverse Events (AEs)
Time frame: 24 months + 12 month optional extension
Treatment-emergent adverse events will be summarized by presenting the number and percentage of patients having any treatment-emergent AE, having an AE in each body system, and having each individual AE.
4 secondary outcomes
Number of participants with changes in Clinical Laboratory Data
Time frame: 24 months + 12 month optional extension
Number of participants with newly occurring or worsening ECG abnormalities
Time frame: 24 months + 12 month optional extension
Number of participants with clinically notable Vital Signs and Body Measurements
Time frame: 24 months + 12 month optional extension
Number of participants who report a positive result for the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 24 months + 12 month optional extension
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 21 Apr 2015.
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 15 inclusion and 12 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 21 Apr 2015. 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. 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?
Number of participants with Treatment-Emergent Adverse Events (AEs) (time frame: 24 months + 12 month optional extension). 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 21 Apr 2015.