Amitriptyline vs GON and SON Blocks in Migraine

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04750967

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of efficacy and safety of amitriptyline and nerve blocks

Condition or Disease	Intervention/Treatment	Phase
Migraine Headache	Drug: Lidocaine 1% Injectable Solution Drug: Amitriptyline	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Comparison of Amitriptyline and Nerve Blocks (GON and SON) in Patients With Migraine

Actual Study Start Date :

Apr 3, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: 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
Active Comparator: Control Amitriptyline 25 mg daily for 6 months	Drug: Amitriptyline Amitriptyline 25 mg daily

Arm

Intervention/Treatment

Experimental: 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

Drug: 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

Active Comparator: Control

Amitriptyline 25 mg daily for 6 months

Drug: Amitriptyline

Amitriptyline 25 mg daily

Outcome Measures

Primary Outcome Measures

Number of Participants with 50% Reduction of Headache Frequency [6 months]
Monthly headache frequency will be followed

Secondary Outcome Measures

Side effects [6 months]
Major and minor side effects will be followed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with migraine according to ICHD-3

Exclusion Criteria:

Being over 50 years or under 18 years
Malignancy and other systemic diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cem Bölük	Istanbul	Fatih	Turkey	34096

Sponsors and Collaborators

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cem Bölük, Principal Investigator, Dr. Lutfi Kirdar Kartal Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04750967

Other Study ID Numbers:

E-70847213-929-3410

First Posted:

Feb 11, 2021

Last Update Posted:

Mar 22, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cem Bölük, Principal Investigator, Dr. Lutfi Kirdar Kartal Training and Research Hospital

greater occipital nerve

supraorbital nerve

nerve blocks

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2022