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.
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
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"
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.