EUCTR2011-000281-35-DE进行中（未招募）不适用
A Multicenter, Randomized, Double-Mask, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of 20 mg Tasimelteon versus Placebo in Totally Blind Subjects with N24HSWD followed by an OLE Phase
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Ability and acceptance to provide informed consent;
- •2. Men or women between 18 – 75 years, inclusive;
- •3. Body Mass Index (BMI) of = 18 and = 33 kg/m2 (BMI = weight (kg)/ [height (m)]2);
- •4. Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without menses for 1 year before screening), or females of child-bearing potential using 2 independent barrier methods of birth control (i.e., condoms, diaphragm, spermicidal agents, cervical cap) for a period of 35 days before the first dosing, during the study and for one month after the last dose and must have a negative at the screening and baseline visits;
- •Note: Hormonal contraception is not considered a reliable method of birth control in this study.
- •Note: For patients over 55 years of age at the screening visit absence of menses for 1 year before screening is sufficient to establish the postmenopausal status. The postmenopausal status of a patient under 55 years of age at the screening visit will be confirmed by measuring the following hormones:
- •Follicle-stimulating hormone (FSH) =40 mIU/mL
- •Estradiol = 30 pg/mL (110.1 pmol/L)
- •5. Willing to comply with study requirements and restrictions including commitment to a fixed 9-hour sleep opportunity during the study;
- •6. Fluent in English or German respectively;
- •7. No perception of light by the subject’s own report;
- •8. Tau length of = 24.25 and the lower bound of 95% CI > 24.0 and the upper bound of 95% CI < 24.9 based on urinary aMT6s rhythms;
- •9. Diagnosis of N24HSWD as determined by:
- •a. 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 and
- •b. Urinary aMT6s demonstrates a progressive delay of the aMT6 acrophase time.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •1. 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;
- •2. 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;
- •3. Subjects who take NSAIDs daily and would not interrupt their use for the 48-hour urine collections and the 24 hours preceding them;
- •4. History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;
- •5. 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 (> 2 drinks/day or > 14 drinks/week);
- •a. Note: A standard drink is equal to 13.7 grams (0.6 ounces) of pure alcohol or
- •o 12-ounces of beer
- •o 8-ounces of malt liquor
- •o 5-ounces of wine
- •o 1.5-ounces or a shot” of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey);
- •6. Subjects having any suicidal ideation of type 4 or 5 on the C-SSRS at Screening or Baseline;
- •7. Subject 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;
- •8. Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
- •9. Subjects who have estimated creatinine clearance (CLcr; based on the Cockcroft-Gault equation) = to 55 mL/min;
- •10. 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;
- •11. Indication of impaired liver function (values for AST, ALT or bilirubin > 2 times Upper Limit of Normal);
- •12. Pregnant or lactating females;
- •13. A positive test for drugs of abuse at the screening visit;
- •Note: A positive drug screen at Visit 1 needs to be discussed with the medical monitor and will be evaluated on a case-by-case basis.
- •14. Smoke more than 10 cigarettes/day;
- •15. Worked night, rotating, or split (period of work, followed by break, and then return to work) shift work within 1 month of the screening visit or plan to work these shifts during the study;
- •16. Participation in a previous tasimelteon (aka VEC-162 or BMS-214778) trial;
- •17. Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening;
- •18. Unwilling or unable to follow the medication restrictions described in Section 8.2., or unwilling or unable to sufficiently wash-out from use of a restricted medication
- •19. Use of melatonin or melatonin agonist within 1 week of the tau identification segment;
- •20. Unable to perform calls to the study IVR system to report questionnaire results;
- •21. Any other sound medical reason as determined by the clinical investigator.
- •22. Legal incompetence or limited legal competence, detainment in an institution for official or legal reasons.
研究者
相似试验
进行中（未招募）
1 期
A clinical trial to evaluate the Safety and Efficacy of Pro-ocular™ topical gel in two different concentration, 0.5% and 1%, when administered in the forehead twice a day for 12 weeks in Patients diagnosed with Dry Eye Syndrome.Dry Eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film and accompanied by ocular symptoms, in which tear film instability, hyperosmolarity, ocular surface inflammation and damage, neurosensory abnormalities play an etiological role. Patient-reported symptoms for DE include dryness, grittiness, itching, redness, fluctuating visual disturbances and ocular fatigue.MedDRA version: 21.1Level: LLTClassification code 10013777Term: Dry eye syndromeSystem Organ Class: 100000004853EUCTR2019-000747-27-ITSOCIETÀ INDUSTRIA FARMACEUTICA ITALIANA (SIFI) SPA105
已完成
3 期
Efficacy and Safety of Bibrocathol 2% Eye Ointment (Posiformin 2%) in the treatment of Chronic Blepharoconjuctivitis, of atleast medium severity.CTRI/2022/08/044716rsapharm India Pvt Ltd196
Unknown
3 期
A clinical trial to study the effects of Mesalamine Delayed-Release Tablets (800 mg) in comparison with Asacol® HD (mesalamine) Delayed-Release Tablets (800 mg) in patients with moderately active ulcerative colitis.CTRI/2010/091/000551Watson Laboratories Inc420
进行中（未招募）
不适用
A Double-Masked, Placebo-Controlled, Multi-Centre, Dose-Ranging Study to Assess the Efficacy and Safety of LX211 as Therapy in Subjects with Active Sight Threatening, Non-Infectious Uveitis.Subjects with active sight-threatening, non-infectious anterior, anterior and intermediate- or panuveitis who require systemic immunosuppression for the control of their disease.MedDRA version: 8.1Level: LLTClassification code 10046851Term: UveitisEUCTR2006-006545-13-DEux Biosciences GmbH100
进行中（未招募）
1 期
A Double-Masked, Placebo-Controlled, Multi-Centre, Parallel Group, Dose-Ranging Study to Assess the Efficacy and Safety of LX211 as Therapy in Subjects with Clinically Quiescent Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis.Subjects with clinically quiescent sight threatening, non-infectious, intermediate-, anterior and intermediate-, posterior- or pan-uveitis.MedDRA version: 8.1Level: LLTClassification code 10046851Term: UveitisEUCTR2006-006544-66-FRux Biosciences GmbH350