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Open label safety study of tasimelteon indicated in the treatment of blind individuals with no light perception having problems synchronizing their internal clock with the 24- hour light-dark cycle.
EU CTIS ID: 2024-516721-31-00
What this study is testing
To characterize the effect of tasimelteon on standard measures of patient's safety.
- 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 informed consent.
- Men or women ≥ 18 years.
- Body Mass Index (BMI) of ≥ 18 and ≤ 40 kg/m2 (BMI = weight (kg)/ [height (m)]2).
- Males, non-fecund females, or females of child-bearing potential (defined as less than 1 year post-menopausal or not surgically sterile) must be using an acceptable method of birth control (e.g., oral contraceptives, patch, intrauterine device [IUD], diaphragm or condom with spermicidal jelly or foam or abstinence, or cervical cap) for a period of 35 days before the first dosing and must have a negative pregnancy test at the screening and baseline visits.
- Willing and able to comply with study requirements and restrictions.
- No perception of light.
You likely can't join if
- 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.
- 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.
- Smoke more than 10 cigarettes/day.
- Participation in a previous tasimelteon (aka VEC-162 or BMS-214778) trial.
See the full eligibility criteria
Who can join
- Ability and acceptance to provide informed consent.
- Men or women ≥ 18 years.
- Body Mass Index (BMI) of ≥ 18 and ≤ 40 kg/m2 (BMI = weight (kg)/ [height (m)]2).
- Males, non-fecund females, or females of child-bearing potential (defined as less than 1 year post-menopausal or not surgically sterile) must be using an acceptable method of birth control (e.g., oral contraceptives, patch, intrauterine device [IUD], diaphragm or condom with spermicidal jelly or foam or abstinence, or cervical cap) for a period of 35 days before the first dosing and must have a negative pregnancy test at the screening and baseline visits.
- Willing and able to comply with study requirements and restrictions.
- 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.
- Affiliated with or beneficiary of a social security system.
What rules you out
- 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.
- 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.
- Smoke more than 10 cigarettes/day.
- Participation in a previous tasimelteon (aka VEC-162 or BMS-214778) trial.
- Exposure to any investigational drug, 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
- Current use of melatonin or melatonin agonist.
- Any other sound medical reason as determined by the clinical investigator.
- 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 unless currently controlled and stable.
- 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.
- Patients 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 or baseline as determined by the clinical investigator.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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.