An open phase IV study for Indian patients (in between 18-65 years) suffering from Insomnia.
- Conditions
- Insomnia,
- Registration Number
- CTRI/2022/08/045113
- Lead Sponsor
- Eisai Pharmaceuticals India Pvt Ltd
- Brief Summary
The study is an open-label, prospective, multicenter, postmarketing surveillance (Phase IV) observational study in insomnia subjects in routine clinical practice. Approximately 110 subjects who are to be initiated on lemborexant (commercial supplies labeled not to be sold) per the investigator’s discretion/judgement will be included in the study. The total study duration will be 2.5 years and will comprise data collection for 6 months for each subject
The clinical decision to initiate lemborexant will already have been made before a subject is identified for the study (i.e., the decision to prescribe lemborexant is independent of the decision to enroll the subject in the study).
Investigators will identify suitable subjects based on their information from routine clinical practice when making the clinical decision to prescribe lemborexant. Per guidelines, subjects will receive commercially available lemborexant labeled not to be sold for commercial purpose, being used for clinical trial. Data will be obtained by reviewing the subject’s medical records and records of the physician’s interviews with subjects at clinic visits. A written informed consent will be signed by the subjects prior to screening and enrolling the patient into the study.
Demography, medical history, psychiatric history, and sleep history will be collected at screening visit. Lemborexant will be prescribed according to the approved prescribing information in India and the treating physician’s clinical judgment based on individual subject’s medical condition, clinical response, and tolerability. Actual dosing will be at the discretion of each investigator, including dose escalation.
Theinitial visit (screening) will be followed by 3 study visits at approximately 1month, 3 months, and 6 months postbaseline, in accordance with routine clinicalpractice (see schedule of procedures and assessments). At each clinic visit, lemborexant doseadjustments and reasons, concomitant medications, and adverse events (AEs) willbe collected. Abnormal results from any clinical investigations, eg, ECG (ifavailable), laboratory samples (if available) or vital signs will be reportedas AEs. At each clinic visit, the PGI‑I questionnaire will be answered by thesubject. Data from visits at other timeswill be recorded and analyzed (if available and data permitting).
Subjects will beconsidered to have completed the study if they discontinue lemborexant and haveat least one post-discontinuation assessment, or if they complete the Visit 4(Month 6) assessments, whichever is sooner. Subjects who are lost to follow-upand are unable to fulfill these conditions will be considered not to havecompleted the study. The maximum estimated duration for each subject on studyis anticipated to be approximately 6 months.
The collectedobservational data will be recorded from the start of lemborexant treatment to6 months (Visit 4). All observational data will be recorded by theinvestigator as part of routine clinical practice.
The end of the study will be the date of thelast study visit for the last subject in the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
- Male or female aged 18 -65 years old (both inclusive) at the time of informed consent.
- A clinical diagnosis of insomnia, as determined by the investigator 3.
- The decision to prescribe lemborexant for the patient has been made independently from the study participation.
- Currently enrolled in another clinical study 2.
- Previously discontinued lemborexant treatment for any reason 3.
- Previously participated in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of TEAEs and serious adverse events (SAEs), discontinuations due to AEs, duration of treatment and dosage at time of AE. Screening, | Month 1, | Month 3, | Month 6.
- Secondary Outcome Measures
Name Time Method The score on the PGI I questionnaire at 1, 3, and 6 months after treatment, discontinuations due to lack of efficacy, duration of treatment, and dosage. Screening,
Trial Locations
- Locations (7)
AIIMS
🇮🇳Delhi, DELHI, India
Asha Hospital
🇮🇳Hyderabad, TELANGANA, India
Central Institute of Behavioral Sciences
🇮🇳Nagpur, MAHARASHTRA, India
Chopda Medicare & Research Centre Pvt Ltd, Magnum Heart Institute
🇮🇳Nashik, MAHARASHTRA, India
Lokmanya Tilak Municipal General Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Sir Gangaram Hospital
🇮🇳Delhi, DELHI, India
St. Johns Hospital
🇮🇳Bangalore, KARNATAKA, India
AIIMS🇮🇳Delhi, DELHI, IndiaDr Manjari TripathiPrincipal investigator9868398269manjari.tripathi@gmail.com