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CTRI Number  CTRI/2022/08/045113 [Registered on: 31/08/2022] Trial Registered Prospectively
Last Modified On: 05/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   An open phase IV study for Indian patients (in between 18-65 years) suffering from Insomnia. 
Scientific Title of Study   An Open Label, Prospective, Multicenter, Postmarketing Surveillance (Phase IV) Study to Evaluate the Safety, Tolerability, and Efficacy of Lemborexant in Adult Subjects (Age 18-65 Years) With Insomnia in India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
E2006-M091-503 Protocol V2 (Amendment V1) Dated 03-Feb-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Dr Balaji Patil 
Designation  General Manager and Head Medical Affairs 
Affiliation  Eisai Pharmaceuticals India Pvt. Ltd. 
Address  Eisai Pharmaceuticals India Pvt. Ltd., 6th Floor, A Wing, Marwah Centre, Krishanlal Marwah Marg, Andheri (East), Mumbai - 400072, Maharashtra, India

Mumbai (Suburban)
MAHARASHTRA
400072
India 
Phone  9004831103  
Fax    
Email  b-patil@eisaiindia.com  
 
Details of Contact Person
Public Query
 
Name  Dr Balaji Patil 
Designation  General Manager and Head Medical Affairs 
Affiliation  Eisai Pharmaceuticals India Pvt. Ltd. 
Address  Eisai Pharmaceuticals India Pvt. Ltd., 6th Floor, A Wing, Marwah Centre, Krishanlal Marwah Marg, Andheri (East), Mumbai - 400072, Maharashtra, India

Mumbai (Suburban)
MAHARASHTRA
400072
India 
Phone  9004831103  
Fax    
Email  b-patil@eisaiindia.com  
 
Source of Monetary or Material Support  
Eisai Pharmaceuticals India Private Limited, Plot Nos: 96, 97, 98, 124 & 126, RamkyPharmacity (SEZ), Parawada, Visakhapatnam District, Andhra Pradesh (India) - 531019  
 
Primary Sponsor  
Name  Eisai Pharmaceuticals India Pvt Ltd 
Address  Eisai Pharmaceuticals India Pvt. Ltd., 6th Floor, A Wing, Marwah Centre, Krishanlal Marwah Marg, Andheri (East), Mumbai - 400072, Maharashtra, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable  Not applicable 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjari Tripathi  AIIMS  Department of Neurology Room no. 705, 7th floor, Neurosciences centre, Ansari Nagar, New Delhi – 110029
New Delhi
DELHI 
9868398269

manjari.tripathi@gmail.com 
Dr G Prasad Rao  Asha Hospital  1st Floor, Room no. 116, 8-2-316/12/A, Road No. 14, Banjara hills, Hyderabad, Telangana - 500034 India
Hyderabad
TELANGANA 
9985900005

prasad40@gmail.com 
Dr Pangaonkar Shailesh  Central Institute of Behavioral Sciences  1st floor, Srividyas, Nawab Layout, Tilak Nagar, Nagpur, Maharashtra, 440010
Nagpur
MAHARASHTRA 
9423105228

pangaonkar11@gmail.com 
Dr Yeole Amit Bhalachandra  Chopda Medicare & Research Centre Pvt Ltd, Magnum Heart Institute  Dept. of Neurology, 3/5, Patil Lane No. 1, Laxmi Nagar, Near KBH Vidyalaya, Canada Corner, Nashik- 422005, Maharashtra
Nashik
MAHARASHTRA 
9819651753

amit_yeole37@rediffmail.com 
Dr Nilesh Bhagwandas Shah  Lokmanya Tilak Municipal General Hospital  Dr. Babasaheb Ambedakar road, Department of Psychiatry, OPD 21, 2nd floor New OPD building, Sion East, Mumbai -400022, Maharashtra
Mumbai
MAHARASHTRA 
9821788658

drnilshah@hotmail.com 
Dr Anshu Rohatgi  Sir Gangaram Hospital  Department of Neurology Room No. 1412, 4th Floor Old Building, Admission Block Sir Gangaram Hospital Marg, Rajinder Nagar New Delhi – 110060
New Delhi
DELHI 
9810159046

rohatgianshu@yahoo.com 
Dr Thomas Mathew  St. Johns Hospital  Department of Neurology IIIrd Floor, Sarjapur Road Koramangala, Bengaluru - 560034
Bangalore
KARNATAKA 
9880247582

chakkuthom@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Ethics Committee Asha Hospital, 8-2-316/12/A, Road No. 14, Banjara Hills, Hyderabad, Telangana - 500034 India.  Approved 
IEC Rughwani Child Care Centre & Hospital, 22, Sindhu Nagar, Mohanlal Rughwani Marg, Jaripatka, Nagpur, Maharashtra - 440014, India  Approved 
Institute Ethics Committee All India Institute of Medical Sciences, Old OT block, Room No.: 102, AIIMS Hospital, Ansari Nagar, New Delhi-110029  Approved 
Institutional Ethics Committee –Human Research - Lokmanya Tilak Municipal Medical College  Approved 
Institutional Ethics Committee, St.Johns Medical College Hospital Sarjapur Road, Koramangala, Bengaluru, Urban Karnataka-560034 India.  Approved 
Magna-Care Ethics Committee, Chopda Medicare & Research Centre Pvt. Ltd, Magnum Heart Institute Canada Corner, Nashik-422005, Maharashtra India  Approved 
Sir Gangaram Hospital Ethics Committee, Sir Gangaram Hospital, Old Rajinder nagar, New Delhi-110060.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G470||Insomnia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lemborexant  Competitive antagonist of both orexin receptors, OX1R and OX2R. A) Dose: Lemborexant film coated tablets 5mg and Lemborexant film coated tablets 10mg. B) Frequency: Administered orally once daily immediately before bedtime. C) Route of administration: Oral. D) Total duration of intervention: 6 months of Study drug intervention as per protocol. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female aged 18 -65 years old (both inclusive) at the time of informed consent.
2. 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. 
 
ExclusionCriteria 
Details  1. Currently enrolled in another clinical study
2. Previously discontinued lemborexant treatment for any reason
3. Previously participated in this study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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,
Month 1,
Month 3,
Month 6 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)
Modification(s)  
23/09/2022 
Date of Study Completion (India) 27/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

The initial visit (screening) will be followed by 3 study visits at approximately 1 month, 3 months, and 6 months postbaseline, in accordance with routine clinical practice (see schedule of procedures and assessments).  At each clinic visit, lemborexant dose adjustments and reasons, concomitant medications, and adverse events (AEs) will be collected. Abnormal results from any clinical investigations, eg, ECG (if available), laboratory samples (if available) or vital signs will be reported as AEs. At each clinic visit, the PGI‑I questionnaire will be answered by the subject.  Data from visits at other times will be recorded and analyzed (if available and data permitting). 

Subjects will be considered to have completed the study if they discontinue lemborexant and have at least one post-discontinuation assessment, or if they complete the Visit 4 (Month 6) assessments, whichever is sooner. Subjects who are lost to follow-up and are unable to fulfill these conditions will be considered not to have completed the study. The maximum estimated duration for each subject on study is anticipated to be approximately 6 months.

The collected observational data will be recorded from the start of lemborexant treatment to 6 months (Visit 4). All observational data will be recorded by the investigator as part of routine clinical practice.

The end of the study will be the date of the last study visit for the last subject in the study.

 
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