Non 24 Hour Sleep Wake DisorderPhase 3NCT01218789
Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder 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 7 sites in France.
Trial summary
The purpose of this study is to evaluate the safety of a one year open-label treatment of tasimelteon in male and female subjects with Non-24-Hour Sleep-Wake Disorder. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 140 participants
- Where
- 7 sitesFrance
- Study dates
- 28 Oct 2010to 5 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and acceptance to provide informed consent;
- No perception of light;
- History (within the last 3 months) of trouble sleeping at night difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire
- Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study;
Who cannot join
- Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the primary cause of the sleep disturbance based on clinical investigator medical judgment;
- Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
- 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;
- Smoke more than 10 cigarettes/day
- Participation in a previous tasimelteon (aka VEC-162 or BMS-214778) trial;
- Use of central nervous system prescription or OTC medications, other than melatonin, that affects the sleep-wake cycle within 3 weeks or 5 half-lives (whichever was longer) of Baseline;
- Use of melatonin or melatonin agonist;
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Study site
Garches
Study site
Lille
Study site
Lyon
Study site
Montpellier
Study site
Paris
Study site
Rennes
Study site
Toulouse
About this study
Official title: Open-Label Safety Study of a 1-Year 20 mg Dose Regimen of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder (N24HSWD) in Blind Individuals With No Light Perception
The purpose of this study is to evaluate the safety of a one year open-label treatment of tasimelteon in male and female subjects with Non-24-Hour Sleep-Wake Disorder.
Read the detailed description
Non-24-Hour Sleep-Wake Disorder (N24HSWD) occurs when individuals, primarily those without light perception, 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 if < 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.
This will be a multicenter, open-label study. The study has two phases: the screening phase and the evaluation phase. The screening phase is comprised of a screening visit where a patient's general health and initial eligibility will be evaluated. The evaluation phase is comprised of a baseline visit and a 52 week segment. Patients that meet all entry criteria for the study at baseline visit will enter the treatment segment where patients will be asked to take 20 mg tasimelteon daily approximately 60 minutes prior to their target bedtime for 52 weeks in an open-label fashion. An optional sub-study extension phase is available to subjects who complete the first year of treatment and consists of continued open-label treatment for up to 3 years additional.
- 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 1 year
| Study group | Role | What they receive |
|---|---|---|
| tasimelteon | Experimental | 20 mg tasimelteon capsules, PO daily for 1 year Receives: Drug: tasimelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs).
The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Measured: Week 4
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs).
The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Measured: Week 8
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs).
The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Measured: Week 12
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs).
The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Measured: Week 16
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs).
The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Measured: Week 26
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs).
The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Measured: Week 34
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs).
The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Measured: Week 42
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs).
The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Measured: Week 52
Secondary outcomes (3)
Patient Global Impression of Change (PGI-C)
A patient rated assessment of reported nighttime sleep
Measured: Weeks 8, 16, 26, 34, 42, 52
Clinical Global Impression of Change (CGI-C)
rate of total improvement due to drug as viewed by the clinician
Measured: Weeks 8, 16, 26, 34, 42, 52
Patient Global Impression of Change (PGI-C)
A patient rated assessment on daytime naps
Measured: Weeks 8, 16, 26, 34, 42, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study start28 Oct 2010
- Primary completion5 Dec 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218789
- Sponsor's protocol ID
- VP-VEC-162-3202
- Status last verified
- Apr 2024
- First submitted
- 28 Sep 2010
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Safety Study of a 1-Year 20 mg Dose Regimen of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder (N24HSWD) in Blind Individuals With No Light Perception
- ClinicalTrials.gov ID
- NCT01218789
- Acronym / sponsor ID
- VP-VEC-162-3202
- 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
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2010 (actual)
- Primary completion
- 5 Dec 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 11 Oct 2010 (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 a one year open-label treatment of tasimelteon in male and female subjects with Non-24-Hour Sleep-Wake Disorder.
Detailed description
Non-24-Hour Sleep-Wake Disorder (N24HSWD) occurs when individuals, primarily those without light perception, 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 if < 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.
This will be a multicenter, open-label study. The study has two phases: the screening phase and the evaluation phase. The screening phase is comprised of a screening visit where a patient's general health and initial eligibility will be evaluated. The evaluation phase is comprised of a baseline visit and a 52 week segment. Patients that meet all entry criteria for the study at baseline visit will enter the treatment segment where patients will be asked to take 20 mg tasimelteon daily approximately 60 minutes prior to their target bedtime for 52 weeks in an open-label fashion. An optional sub-study extension phase is available to subjects who complete the first year of treatment and consists of continued open-label treatment for up to 3 years additional.
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 1 year |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability and acceptance to provide informed consent;
- No perception of light;
- History (within the last 3 months) of trouble sleeping at night difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire
- Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study;
Key exclusion criteria (8 listed)
- Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the primary cause of the sleep disturbance based on clinical investigator medical judgment;
- Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
- 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;
- Smoke more than 10 cigarettes/day
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 1 year | Drug | tasimelteon |
Primary outcome
Safety Evaluations
Time frame: Week 4
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
Time frame: Week 8
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
Time frame: Week 12
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
Time frame: Week 16
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
Time frame: Week 26
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
Time frame: Week 34
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
Time frame: Week 42
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
Time frame: Week 52
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
3 secondary outcomes
Patient Global Impression of Change (PGI-C)
Time frame: Weeks 8, 16, 26, 34, 42, 52
Clinical Global Impression of Change (CGI-C)
Time frame: Weeks 8, 16, 26, 34, 42, 52
Patient Global Impression of Change (PGI-C)
Time frame: Weeks 8, 16, 26, 34, 42, 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 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 7 sites in France.
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 8 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
Results are not available in the source record.
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?
Safety Evaluations (time frame: Week 4). The study lists 8 primary outcomes in all. 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 3 Apr 2024.