NCT04750967

Brief Summary

Comparison of efficacy and safety of amitriptyline and nerve blocks

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 3, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

February 8, 2021

Last Update Submit

September 7, 2023

Conditions

MigraineHeadache

Keywords

greater occipital nervesupraorbital nervenerve blocks

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with 50% Reduction of Headache Frequency

    Monthly headache frequency will be followed

    6 months

Secondary Outcomes (1)

  • Side effects

    6 months

Study Arms (2)

Active

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Amitriptyline 25 mg daily for 6 months

Drug: Amitriptyline

Interventions

Lidocaine 1% Injectable SolutionDRUG

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
AmitriptylineDRUG

Amitriptyline 25 mg daily

Control

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with migraine according to ICHD-3

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cem Bölük

Istanbul, Fatih, 34096, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

LidocaineAmitriptyline

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 11, 2021

Study Start

April 3, 2021

Primary Completion

January 1, 2022

Study Completion

July 15, 2023

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations

TU(1)