| CTRI Number |
CTRI/2022/10/046474 [Registered on: 13/10/2022] Trial Registered Prospectively |
| Last Modified On: |
11/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Investigator Initiated Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To determine the effect of prochlorperazine in vestibular migraine patients |
|
Scientific Title of Study
|
To study the effectiveness and safety of prochlorperazine in patients suffering from vestibular
migraine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PROC-D22-0208 July 15, 2022,Version: 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Ilambarathi |
| Designation |
Principal Investigator |
| Affiliation |
ENT Surgeon, IGENT Clinic |
| Address |
IGENT CLINIC, 1 floor Velan building 4th main road Nanganallur chennai 61.
Chennai
TAMIL NADU
600061
India |
| Phone |
9884076599 |
| Fax |
|
| Email |
drbarathi54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Ilambarathi |
| Designation |
Principal Investigator |
| Affiliation |
ENT Surgeon, IGENT Clinic |
| Address |
IGENT CLINIC, 1 floor Velan building 4th main road Nanganallur chennai 61.
Chennai
TAMIL NADU
600061
India |
| Phone |
9884076599 |
| Fax |
|
| Email |
drbarathi54@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Ilambarathi |
| Designation |
Principal Investigator |
| Affiliation |
ENT Surgeon, IGENT Clinic |
| Address |
IGENT CLINIC, 1 floor Velan building 4th main road Nanganallur chennai 61.
Chennai
TAMIL NADU
600061
India |
| Phone |
9884076599 |
| Fax |
|
| Email |
drbarathi54@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Pvt. Ltd. Floor 16, Godrej BKC,
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E)
Mumbai – 400 051 |
|
|
Primary Sponsor
|
| Name |
Abbott Healthcare Pvt Ltd |
| Address |
Floor 16, Godrej BKC,
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E)
Mumbai – 400 051
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhrubo Roy |
Amri Hospital |
Amri hospital, Jadavpur 230, Barakhola, Jadhavpur Kolkata, West Bengal-700099-India
Kolkata
WEST BENGAL |
9831214266
dhrubogiri@gmail.com |
| Dr M Ilambarathi |
IGENT Clinic |
IGNET CLINIC, 1st Floor Velan Building, 4th Main Nanganallur Chennai 61, Tamilnadu
Chennai
TAMIL NADU |
9884076599
drbarathi54@gmail.com |
| Dr Savyasachi Saxena |
Neo Clinic |
Neo Clinic
117 A, Gyan Khand IV
Indirapuram, Ghaziabad, 201010
Ghaziabad
UTTAR PRADESH |
9990137717
ent.neoclinic@gmail.com |
| Dr Suresh Kumar |
Sree Krishna ENT Care Center |
Sree Krishna ENT Care Center
MM Towers, Axis Bank Complex
Ambattur OT, Chennai 600053
Chennai
TAMIL NADU |
9840682538
drsuresh_k@hotmail.com |
| Dr Aditya Yeolekar |
Yashwantrao Chavan Memorial Hospital, Pimpri |
Yashwantrao Chavan Memorial Hospital, Pimpri. Sant Tukaram Nagar, Near D.Y.Patil Medical College Vallabhnagar, Near Fire Brigade Station, Pimpri Pune Maharashtra - 411018
Pune
MAHARASHTRA |
9823334892
adidoc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| AMRI Hospital Mukundapur Ethics Committee |
Approved |
| Good Society for Ethical Research |
Approved |
| Institutional Ethics Committee, Yashwantrao Chavan Memorial Hospital Pimpri |
Approved |
| Ripon Ethics committee |
Approved |
| Ripon Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Single Arm Study, Not Applicable |
| Intervention |
Prochlorperazine |
Dose 15 mg per day (divided into 3 dose, 5 mg each)
Frequency: Three Times a day Route of administration: Oral
Total duration: 5 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients in the age group of 18-65 years
2. Patients diagnosed of vestibular migraine based on to ICHD-3 criteria9
3. Patient who has read the informed consent form, has understood the relevant aspects of the clinical study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the clinical study and the performance of any procedure
|
|
| ExclusionCriteria |
| Details |
1. Patients on prochlorperazine or any other anti-vertigo therapy drugs in the past 30 days
2. Patients with history of psychiatric illness in the past 6 months
3. Patients on anti-psychotic or anti-depressant medication in the past 6 months
4. Patients with history of cardiovascular, kidney or liver disorder
5. Patients with suspected or established subcortical brain damage, with or without hypothalamic damage
6. Females who are pregnant/planning to become pregnant/not ready to use contraceptive measures or are lactating
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Number and proportion of MAV patients achieving improvement in Clinical Response, described as worsening (increased by 1 level), no change, or by using a 4-point Likert scale ranging from moderate (reduced by 1 level) to excellent (reduced by 4 levels), as graded using SVVSLCRE, from baseline (day 0) to day 6, day 15, and day 30.
Clinical Response will be assessed using SVVSLRE reading. Clinical response is described as worsening, no change, or by using a 4-point Likert scale ranging from moderate (reduced by 1 level) to excellent (reduced by 4 levels). [Moderate, Good, Very Good, Excellent] |
Baseline (day 0) to day 6, day 15, and day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number and proportion of patients with improvement in symptoms assessed using scale of vestibular vertigo severity level from baseline to end of treatment period. Symptom severity is graded on the SVVSLCRE (Level I [0–2] absent vestibular vertigo Level V [8-10], very severe vestibular vertigo). The severity of vertigo-associated symptoms (faintness headache, hearing loss, nausea, vomiting, and tinnitus) will be assessed, and symptom severity will be graded based on SVVSLCRE |
Baseline (day 0) to day 6, day 15, and day 30. |
|
|
Target Sample Size
|
Total Sample Size="259"
Sample Size from India="259"
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)
|
14/10/2022 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
NA |