Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere
Conditions
Interventions
Intervention1: Suvorexant Tablets 10 mg, 15 mg and 20 mg: Dose: 01 tablet of the prescribed dose should be taken at night within 30 minutes of going to bed (with at least 7 hours remaining prior to pl
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Sun Pharma Laboratories Ltd SPLL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 to 65 years (both inclusive) at the time of informed consent 2. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Insomnia Disorder 3. Patients should have time to sleep onset greater than or equal to 30 minutes and total sleep time of less than 6.5 hours on at least 4 out of 7 nights in last 4 weeks before screening 4. Insomnia severity index score greater than or equal to 15 at Screening and randomization visit 5. Women of childbearing potential must have a negative urine pregnancy test at screening visit and randomization visit and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of study (such contraception may include hormonal birth control e.g. combined oestrogen and progestogen containing [oral, intravaginal or transdermal] or progesterone only [oral, injectable or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence). [Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhoea and be greater than 45 years of age]. 6. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners should be practicing highly effective contraception throughout the study period. Contraception by female partner is not required if she is not a woman of childbearing potential) [No sperm donation is allowed during the study period]
Exclusion criteria
Exclusion criteria: Patient will be excluded if any of the exclusion criteria listed below is met: 1. Patients with Body Mass Index (BMI) greater than 40 kg/m2 2. Patients with history of sleep related breathing disorders such as obstructive sleep apnea, central sleep apnea periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, narcolepsy, cataplexy, parasomnia including nightmare disorder, sleep terror disorder, sleep walking disorder, sleep driving disorder, primary hypersomnia, excessive daytime sleepiness disorder not attributable to primary insomina, periodic limb movement disorder 3. Patient who have difficulty sleeping due to underlying medical condition such as but not limited to cardiac disease, nocturia (greater than 3 times/night), asthma, gastroesophageal reflux disease (GERD), hot flashes, pain due to chronic conditions, migraine etc 4. Patients with major travel (across time zones) in 2 weeks prior to screening or expected to travel during the study 5. Patients with history of working in shifts and/or working in night shifts in 2 weeks prior to screening or will be required to work in a shift and/or night shift during the study. 6. Patients with neurological disorder, such as but not limited to seizures, stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, or clinically significant head trauma 7. Patient who has history of any psychiatric condition such as bipolar disorder, major depression, posttraumatic stress disorder etc. 8. A lifetime history of a suicidal attempt or history of Suicidal behaviour or suicidal ideation within 4 weeks before screening 9. Patients with History of alcohol or substance dependency or abuse in last 2 years 10. Patients with positive result of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening visit 11. Patients with any significant cardiovascular abnormality including acute coronary syndrome, unstable angina, congestive heart failure (NYHA III or IV), cardiogenic syncope, cardiomyopathy, Any symptomatic arrythmia, AV conduction diseases (second- or third-degree AV block), sick sinus syndrome, bradycardia (heart rate at resting less than 45 at screening), or accessory bypass tract (for example, Wolff- Parkinson-White), QTcF greater than 450 ms) at screening. 12. Patients with history of any liver disorder of gastrointestinal disorder or gastrointestinal surgery including gastric bypass or gastric banding surgery. 13. Subject had a history of malignancy 5 years or more prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer 14. Patients who are not willing to avoid alcohol during the study 15. Prior use of orexin receptor antagonist and no adequate response to therapy 16. Hypersensitivity to the study drug or any of the excipients. 17. Patients with history of any clinically significant medical and/or psychological condition or laboratory abnormalities that, in the opinion of the Investigator or Sponsor s Medical Monitor would jeopardize the safety of the patient or affect the validity of the study results 18. Patient with history of participation in another clinical trial in the past 3 months of Screening 19. Employee of the Sponsor or Investigator or study centre with direct involvement in the propo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in latency to sleep onset at week 12Timepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in latency to sleep onset till week 8Timepoint: Week 8;Change from baseline in total sleep time till week 12Timepoint: Week 12;Change from baseline in wakefulness after persistent sleep till week 12Timepoint: Week 12;Change from baseline in number of awakenings at till week 12Timepoint: Week 12;Change from baseline Insomnia Severity Index (ISI) till week 12Timepoint: Week 12 | — |
Countries
India
Contacts
Public ContactDr Rajiv Yadav
Sun Pharma Laboratories Limited
Outcome results
None listed