To determine the effect of prochlorperazine in vestibular migraine patients

Not Applicable

Conditions: Health Condition 1: G439- Migraine, unspecified

Registration Number: CTRI/2022/10/046474

Lead Sponsor: Abbott Healthcare Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•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. <br/ ><br>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]Timepoint: Baseline (day 0) to day 6, day 15, and day 30.

Secondary Outcome Measures

Name	Time	Method
umber 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 SVVSLCRETimepoint: Baseline (day 0) to day 6, day 15, and day 30.