Amitriptyline vs GON and SON Blocks in Migraine

NCT ID: NCT04750967

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-03

Study Completion Date

2023-07-15

Brief Summary

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Comparison of efficacy and safety of amitriptyline and nerve blocks

Detailed Description

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This study aims to compare the efficacy and safety of amitriptyline and nerve blocks (greater occipital nerve and supraorbital nerve)

Conditions

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Migraine Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Active

Greater occipital nerve and supraorbital nerve block with 1% lidocaine once a week for first four weeks then once a month for 5 months

Group Type EXPERIMENTAL

Lidocaine 1% Injectable Solution

Intervention Type DRUG

Repeated injections of lidocaine to greater occipital nerve and supraorbital nerve once a week for first four weeks then once a month for five months

Control

Amitriptyline 25 mg daily for 6 months

Group Type ACTIVE_COMPARATOR

Amitriptyline

Intervention Type DRUG

Amitriptyline 25 mg daily

Interventions

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Lidocaine 1% Injectable Solution

Repeated injections of lidocaine to greater occipital nerve and supraorbital nerve once a week for first four weeks then once a month for five months

Intervention Type DRUG

Amitriptyline

Amitriptyline 25 mg daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with migraine according to ICHD-3

Exclusion Criteria

* Being over 50 years or under 18 years
* Malignancy and other systemic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Cem Bölük

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cem Bölük

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E-70847213-929-3410

Identifier Type: -

Identifier Source: org_study_id

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