TASIMELTEON for Non-24-Hour Sleep-Wake Disorder

Inclusion criteria

• {"criterion_text":"- Ability and acceptance to provide informed consent."}
• {"criterion_text":"- Men or women ≥ 18 years."}
• {"criterion_text":"- Body Mass Index (BMI) of ≥ 18 and ≤ 40 kg/m2 (BMI = weight (kg)/ [height (m)]2)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Willing and able to comply with study requirements and restrictions."}
• {"criterion_text":"- No perception of light."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Affiliated with or beneficiary of a social security system."}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Indication of impaired liver function (values for AST, ALT or bilirubin > 2 times Upper Limit of Normal)."}
• {"criterion_text":"- Pregnant or lactating females."}
• {"criterion_text":"- A positive test for drugs of abuse at the screening visit."}
• {"criterion_text":"- Smoke more than 10 cigarettes/day."}
• {"criterion_text":"- Participation in a previous tasimelteon (aka VEC-162 or BMS-214778) trial."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Unwilling or unable to discontinue usage of medication listed in Section 8.2.1"}
• {"criterion_text":"- Current use of melatonin or melatonin agonist."}
• {"criterion_text":"- Any other sound medical reason as determined by the clinical investigator."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- History of intolerance and/or hypersensitivity to melatonin or melatonin agonists."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Patients having any current suicidal ideation of type 4 or 5 on the C-SSRS at Screening or Baseline."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable."}
• {"criterion_text":"- Patients who have estimated creatinine clearance (CLcr; based on the Cockcroft-Gault equation) ≤ to 55 mL/min."}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Adverse events (AEs) including suicidal ideation or behavior, changes in vital signs, clinical laboratory evaluations, electrocardiograms (ECGs) and physical exam findings during treatment.","definition_or_measurement_approach":"AEs and safety signals collected during treatment period: recording of adverse events including suicidal ideation/behavior, monitoring of vital signs, clinical laboratory evaluations, ECGs and physical examination findings."}

Secondary endpoints

• {"endpoint_text":"- Patient Global Impression-Change (PGI-C) for nighttime sleep.","definition_or_measurement_approach":"Measured using the Patient Global Impression of Change (PGI-C) instrument for nighttime sleep as reported by the patient."}
• {"endpoint_text":"- Patient Global Impression-Change (PGI-C) for daytime naps.","definition_or_measurement_approach":"Measured using the Patient Global Impression of Change (PGI-C) instrument for daytime naps as reported by the patient."}
• {"endpoint_text":"- Clinical Global Impression-Change (CGI-C).","definition_or_measurement_approach":"Measured using the Clinical Global Impression of Change (CGI-C) instrument."}

France

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

452

Number Of Sites

2

Number Of Participants

140

Primary sponsor

Full Name

Vanda Pharmaceuticals Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Medpace Finland Oy

Responsibilities

sponsorDuties codes: 1,10,11,12,13,15; Clinical Trial Management, IDMC, Imaging

Name

United BioSource (Suisse) S.A.

Responsibilities

sponsorDuties codes: 8

Third parties

• {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"United BioSource (Suisse) S.A.","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
• {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,15; value: Clinical Trial Management, IDMC, Imaging","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}