BridgeMD
A multicenter, double-blind, randomized study to evaluate the effects of tasimelteon vs. placebo in participants with Delayed Sleep-Wake Phase Disorder (DSWPD)
EU CTIS ID: 2024-516962-13-00
What this study is testing
To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to placebo on Sleep Onset (change from baseline) in participants over a 28-day period, as measured by sleep diary.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ability and acceptance to provide written informed consent.
- Must have a reported sleep onset of 00:00 or later by daily sleep diary, on at least 5 of the 7 days per screening week.
- Must have 80% compliance for daily sleep diary completion, throughout screening.
- Must maintain an actual bedtime ± 15 minutes from the desired bedtime by daily sleep diary, on at least 5 of the 7 days during the run-in.
- Must have a reported sleep onset of ≥ 2 hours from the desired bedtime by daily sleep diary, on at least 5 of the 7 days during the run-in.
- A confirmed clinical diagnosis of DSWPD, as per International Classification of Sleep Disorders-3 (ICSD-3).
You likely can't join if
- Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal, or metabolic dysfunction unless currently controlled and stable.
- Recent history of pulmonary embolism/deep vein thrombosis (DVT) or short-term blood thinner treatment as an outpatient (i.e., Coumadin, Lovenox, Heparin), one year prior to the screening visit.
- Recent history or family history of thrombosis or hypercoagulable state (i.e., Factor V Leiden, Factor VIII deficiency, Protein C & S deficiency), one year prior to the screening visit.
- Pregnancy, recent pregnancy (within 6 weeks of the screening visit), or females who are breastfeeding.
- History of restless leg syndrome, sleep apnea, or periodic limb movement disorder and/or have current diagnosis as confirmed by the screening visit.
- History or evidence of sleep apnea as determined by a high-risk score in any two of the three categories in The Berlin Questionnaire (TBQ), unless ruled out by a recent sleep study for sleep apnea.
See the full eligibility criteria
Who can join
- Ability and acceptance to provide written informed consent.
- Must have a reported sleep onset of 00:00 or later by daily sleep diary, on at least 5 of the 7 days per screening week.
- Must have 80% compliance for daily sleep diary completion, throughout screening.
- Must maintain an actual bedtime ± 15 minutes from the desired bedtime by daily sleep diary, on at least 5 of the 7 days during the run-in.
- Must have a reported sleep onset of ≥ 2 hours from the desired bedtime by daily sleep diary, on at least 5 of the 7 days during the run-in.
- A confirmed clinical diagnosis of DSWPD, as per International Classification of Sleep Disorders-3 (ICSD-3).
- Males or females between 18 – 75 years, inclusive.
- Body Mass Index (BMI) of ≥ 18 and ≤ 35 kg/m2 (BMI = weight (kg)/[height (m)]2).
- Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or participant is postmenopausal for at least 2 years), or females of childbearing potential using an acceptable method of birth control (abstinence, the use of 2 independent barrier methods, hormonal contraception plus 1 barrier method, or surgically sterilized partner) for a period of 35 days before the first dosing, and agree to continue using these methods during the study, and for one month after the last dose. Women of Childbearing Potential (WOCBP) must also have a negative pregnancy test at V1, V2, and V3.
- In good health as determined by a medical history, physical examination, electrocardiogram (ECG), serum chemistry and hematology, and urinalysis.
- Willing to comply with study procedures and restrictions with fixed sleep time during the study and to attend regularly scheduled clinic visits as specified in the protocol.
- Must have a desired bedtime at least 2 hours earlier than the habitual sleep onset (determined by the DSPD Screening Questionnaire). There must be at least a 2 hour difference between the reported sleep onset, by daily sleep diary, and the desired bedtime (determined by the DSPD Screening Questionnaire), on at least 5 of the 7 days per screening week.
- Must have a sleep onset of 00:00 or later (determined by the DSPD Screening Questionnaire).
What rules you out
- Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal, or metabolic dysfunction unless currently controlled and stable.
- Recent history of pulmonary embolism/deep vein thrombosis (DVT) or short-term blood thinner treatment as an outpatient (i.e., Coumadin, Lovenox, Heparin), one year prior to the screening visit.
- Recent history or family history of thrombosis or hypercoagulable state (i.e., Factor V Leiden, Factor VIII deficiency, Protein C & S deficiency), one year prior to the screening visit.
- Pregnancy, recent pregnancy (within 6 weeks of the screening visit), or females who are breastfeeding.
- History of restless leg syndrome, sleep apnea, or periodic limb movement disorder and/or have current diagnosis as confirmed by the screening visit.
- History or evidence of sleep apnea as determined by a high-risk score in any two of the three categories in The Berlin Questionnaire (TBQ), unless ruled out by a recent sleep study for sleep apnea.
- History of drug or alcohol abuse as defined in DSM-V, 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).
- A positive test for substances of abuse at the screening visit, V2, or V3.
- Traveled more than 3 time zones 2 weeks prior to the screening visit.
- Traveled outside the origination time zone within 1 week before the screening period and until the end of the treatment period.
- Worked regular night shifts in the 2 months leading up to the screening visit.
- Acute exacerbation of an existing psychiatric comorbid condition that requires change in treatment or intervention in the 3 months prior to the screening visit.
- Randomization in a previous tasimelteon (VEC-162 or BMS-214778) trial.
- Use of any investigational drug, including placebo, any central nervous system medication (unless on a chronic, stable dose of the medication), or any other prescription or over-the-counter (OTC) medication that affects the sleep-wake cycle within 3 weeks or 5 half-lives (whichever is longer) of the screening visit.
- Participant is at risk of suicide, in the opinion of the Investigator. Evidence of suicide risk could include any suicide attempt or any other suicidal behavior within 12 months of the screening visit or any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at V1, V2, or V3.
- Unwilling or unable to follow the medication restrictions, or unwilling or unable to sufficiently washout from use of a restricted medication.
- Use of melatonin or melatonin agonist within 3 weeks of the screening visit.
- Have a reported change of ≥ 2 hours from the average reported sleep onset from screening by daily sleep diary, during the run-in.
- Any other sound medical reason as determined by the Investigator.
- History of intolerance and/or hypersensitivity to melatonin or melatonin agonists.
- Indication of impaired liver function (values for enzymes aspartate transaminase (AST) and alanine transaminase (ALT) or bilirubin > 2 times the Upper Limit of Normal).
- Clinically significant deviation from normal in clinical laboratory results, vital sign measurements, or physical examination findings as determined by the Investigator.
- Major surgery, trauma (including broken pelvis/legs), illness (i.e., sepsis, stroke), general anesthesia, or immobility for 3 or more days within 30 days of the screening visit.
- Current tobacco user or quit using tobacco within 30 days of the screening visit.
- Active cancer or cancer treatment within 6 months of the screening visit.
- Central venous catheter in place or within 30 days of the screening visit.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.