NCT05608642

Brief Summary

Medication overuse headache is the chronicity of headaches, which occurs more than 15 days a month, as a result of frequent use of painkillers, opioids or migraine attack drugs (ergotamine, triptan) in individuals with pre-existing primary headache disease. In the treatment of this headache, two ways can be followed as slow drug discontinuation or sudden drug discontinuation. The most commonly used method is the sudden discontinuation of the overused analgesic agent, the initiation of prophylactic treatment, and then the application of bridge therapy for 6-10 days. Intravenous hydration, steroids, antiemetics, neuroleptic drugs and local anesthetic drugs such as lidocaine can be used in bridge treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 22, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 23, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

October 23, 2022

Last Update Submit

November 2, 2022

Conditions

Medication Overuse Headache

Keywords

lidocaineprednisoloneintravenous hydration

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale (VAS)

    It is a scale that measures the severity of pain. Scored between ''0: no pain'' and ''10: worst pain'' .

    4 weeks

Study Arms (3)

Group given intravenous hydration

ACTIVE COMPARATOR

The first group consists of patients given 500 cc intravenous saline for 1 hour.

Other: Intravenous hydration

Group given intravenous prednisolone

ACTIVE COMPARATOR

Second group; consists of patients who were given 80 mg of intravenous prednisolone for the first 4 days and then given gradually decreasing doses of prednisolone in the following days.

Other: Intravenous prednisolone

Group given intravenous lidocaine

ACTIVE COMPARATOR

Third group; includes patients given 2 mg/kg intravenous lidocaine by 1-hour infusion.

Other: Intravenous lidocaine

Interventions

Intravenous hydrationOTHER

500 cc intravenous serum for 1 hour in the first group service consists of patients who have been given.

Group given intravenous hydration
Intravenous prednisoloneOTHER

The second group consisted of patients who were given 80 mg intravenous prednisolone for the first 4 days and then gradually reduced doses of prednisolone in the following days.

Group given intravenous prednisolone
Intravenous lidocaineOTHER

The third group includes patients in whom 2 mg/kg of intravenous lidocaine is given by 1-hour infusion.

Group given intravenous lidocaine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medication overuse headache
  • Chronic migraine

You may not qualify if:

  • Other headaches will not accompany (tension-type headache, cluster...)
  • Pregnancy
  • Epilepsia
  • Heart disease
  • Bradikardia
  • Hypertension
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazıt Teaching and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache Disorders, Secondary

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ömer Taylan Akkaya

    Diskapi Yildirim Beyazıt Teaching and Research Hospital

    STUDY CHAIR

  • Gevher Rabia Genç Perdecioğlu

    Diskapi Yildirim Beyazıt Teaching and Research Hospital

    STUDY DIRECTOR

  • Hüseyin Alp Alptekin

    Diskapi Yildirim Beyazıt Teaching and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 23, 2022

First Posted

November 8, 2022

Study Start

October 22, 2022

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

November 8, 2022

Record last verified: 2022-11

Locations

TU(1)