search
Back to results

Amitriptyline vs GON and SON Blocks in Migraine

Primary Purpose

Migraine, Headache

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lidocaine 1% Injectable Solution
Amitriptyline
Sponsored by
Dr. Lutfi Kirdar Kartal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine focused on measuring greater occipital nerve, supraorbital nerve, nerve blocks

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Cem Bölük

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active

Control

Arm Description

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

Amitriptyline 25 mg daily for 6 months

Outcomes

Primary Outcome Measures

Number of Participants with 50% Reduction of Headache Frequency
Monthly headache frequency will be followed

Secondary Outcome Measures

Side effects
Major and minor side effects will be followed

Full Information

First Posted
February 8, 2021
Last Updated
September 7, 2023
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04750967
Brief Title
Amitriptyline vs GON and SON Blocks in Migraine
Official Title
Comparison of Amitriptyline and Nerve Blocks (GON and SON) in Patients With Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 3, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
July 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparison of efficacy and safety of amitriptyline and nerve blocks
Detailed Description
This study aims to compare the efficacy and safety of amitriptyline and nerve blocks (greater occipital nerve and supraorbital nerve)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Headache
Keywords
greater occipital nerve, supraorbital nerve, nerve blocks

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Greater occipital nerve and supraorbital nerve block with 1% lidocaine once a week for first four weeks then once a month for 5 months
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Amitriptyline 25 mg daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Lidocaine 1% Injectable Solution
Intervention Description
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
Intervention Name(s)
Amitriptyline
Intervention Description
Amitriptyline 25 mg daily
Primary Outcome Measure Information:
Title
Number of Participants with 50% Reduction of Headache Frequency
Description
Monthly headache frequency will be followed
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Side effects
Description
Major and minor side effects will be followed
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with migraine according to ICHD-3 Exclusion Criteria: Being over 50 years or under 18 years Malignancy and other systemic diseases
Facility Information:
Facility Name
Cem Bölük
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34096
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Amitriptyline vs GON and SON Blocks in Migraine

We'll reach out to this number within 24 hrs