| CTRI Number |
CTRI/2024/11/076750 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating retrospective data of Nerivio Device in
Chronic and Episodic Migraine |
|
Scientific Title of Study
|
Evaluating the Effectiveness and Safety of Nerivio Device in Chronic and Episodic Migraine A Retrospective Observational Real World Evidence Analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DRL-IND-GGI-077-NERI/2024 Ver 1.0 date 21 Oct 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mayank Dhore |
| Designation |
Principal Investigator |
| Affiliation |
Dr Reddys Laboratories limited |
| Address |
Dr Reddys Laboratories Ltd
Second floor of B Wing
Art Guild House Phoenix Market City LBS Marg Kurla (W) Mumbai 400070
Mumbai
MAHARASHTRA
400070
India |
| Phone |
8860530669 |
| Fax |
|
| Email |
mayankdhore@drreddys.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Dhore |
| Designation |
Principal Investigator |
| Affiliation |
Dr Reddys Laboratories limited |
| Address |
Dr Reddys Laboratories Ltd
Second floor of B Wing
Art Guild House Phoenix Market City LBS Marg Kurla (W) Mumbai 400070
Mumbai
MAHARASHTRA
400070
India |
| Phone |
8860530669 |
| Fax |
|
| Email |
mayankdhore@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Katare |
| Designation |
Head Clinical Research |
| Affiliation |
Dr Reddys Laboratories limited |
| Address |
Dr Reddys Laboratories Ltd
Second floor of B Wing
Art Guild House Phoenix Market City LBS Marg Kurla (W) Mumbai 400070
Mumbai
MAHARASHTRA
400070
India |
| Phone |
9223772427 |
| Fax |
|
| Email |
sagarkatare@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr Reddys Laboratories Limited |
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories Ltd |
| Address |
Dr Reddys Laboratories Ltd
Second floor of B Wing Art Guild House Phoenix Market City LBS Marg Kurla (W) Mumbai – 400070
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mayank Dhore |
Dr Reddys Laboratories Ltd |
Dr Reddys Laboratories Ltd
Second floor of B Wing
Art Guild House Phoenix Market City LBS Marg Kurla (W) Mumbai 400070
Mumbai
MAHARASHTRA |
8860530669
mayankdhore@drreddys.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksha Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G437||Chronic migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Adults diagnosed with migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria
Patients who have been prescribed and have used REN devices within the past 12 months
|
|
| ExclusionCriteria |
| Details |
Patients with incomplete medical records
Patients with other significant chronic pain disorders
Pregnant or breastfeeding women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Demographic information of the study population
Categorize and assess the types of migraines duration of migraine history and patient profiles
Proportion of patients showing improvement in clinical signs and symptoms of migraine after using Nerivio
Reduction in migraine medication regimen
|
baseline to end of 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of Adverse Event following the use of Nerivio |
Baseline to 12 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
study is a retrospective, observational database study intended to analyze data
collected from Aug 2023 to Jul 2024 from a medical patient support program
conducted for Nerivio Device users. The REN device (Nerivio) is a wearable
which provides pain relief from migraine. The study duration will be of 6 months. The objective of this study is to evaluate the data and understand effectiveness of Nerivio devise in Migraine management |