NCT03767062

Brief Summary

Purpose: In this study, the investigators compared the effectiveness of peripheral nerve block (greater occipital nerve block with supratrochlear nerve block) versus topiramate as detoxification therapies in chronic migraine patients with medication overuse headache. Methods: At least ninety chronic migraine patients with medication overuse headache are aimed to include in this study. Patients will be divided into the two groups. The first group will receive topiramate (n=45, estimated) and the second group will receive nerve block (n=45, estimated) as detoxification therapy. Patients' records regarding the visual analog scale (VAS) scores and headache frequencies are aimed to be collected before and after the therapy. Comparisons regarding VAS scores, headache frequencies, 50% responder rates and 75% responder rates will be performed in between topiramate and nerve block groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 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

December 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 22, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

December 5, 2018

Results QC Date

November 24, 2019

Last Update Submit

January 17, 2020

Conditions

Medication Overuse HeadacheChronic Migraine, Headache

Keywords

Medication overuse headache; Greater occipital nerve block; supratrochlear nerve block; topiramate.

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale

    Range Pain 0-10, 0: No pain, 10: Worst Pain

    Post treatment (4 weeks later)

  • Attack Frequencies

    Number of headaches patients suffer in a month.

    Post treatment (4 weeks later)

Study Arms (2)

Topiramate

ACTIVE COMPARATOR

Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.

Drug: Topamax

Greater Occipital +Supratrochlear Nerve Block

ACTIVE COMPARATOR

Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼" (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.

Procedure: Greater Occipital Nerve Block + Supratrochlear Nerve Block

Interventions

TopamaxDRUG

An antiepileptic agent used for migraine prophylaxis.

Topiramate
Greater Occipital Nerve Block + Supratrochlear Nerve BlockPROCEDURE

An injection to paralyze the occipital and supratrochlear nerves.

Greater Occipital +Supratrochlear Nerve Block

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic migraine diagnosis according to International Classification of Headache-2 Disorders (ICHD)
  • w/o pregnancy or breastfeeding.
  • w/o acute or chronic psychiatric disorders.
  • w/o nephrolithiasis.
  • w/o medication of anticoagulant and antiaggregant.
  • w/o allergy to topiramate or bupivacaine.
  • w/o prophylaxis within the last three months with any of; propranolol, nebivolol, topiramate, valproate, venlafaxine, duloxetine, amitriptyline, flunarizine.
  • w/o previous history of peripheral nerve block, botulinum toxin or acupuncture.
  • w/o history of multiple sclerosis, movement disorders, epilepsy, stroke, and tumor.
  • J-w/o chronic systemic diseases including hypertension, cardiac insufficiency, diabetes, pulmonary disease, kidney disease, liver disease, and peripheral arterial disease.

You may not qualify if:

  • Lost to follow up within the pretreatment period during the detoxification therapy after the detoxification therapy
  • could not tolerate the peripheral nerve block or topiramate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Ceylan

Erzurum, 25000, Turkey (Türkiye)

Location

Related Publications (4)

  • Zwart JA, Dyb G, Hagen K, Svebak S, Holmen J. Analgesic use: a predictor of chronic pain and medication overuse headache: the Head-HUNT Study. Neurology. 2003 Jul 22;61(2):160-4. doi: 10.1212/01.wnl.0000069924.69078.8d.

    PMID: 12874392BACKGROUND

  • Grazzi L, Andrasik F, D'Amico D, Usai S, Kass S, Bussone G. Disability in chronic migraine patients with medication overuse: treatment effects at 1-year follow-up. Headache. 2004 Jul-Aug;44(7):678-83. doi: 10.1111/j.1526-4610.2004.04127.x.

    PMID: 15209690BACKGROUND

  • Silberstein SD, Lipton RB, Dodick DW, Freitag FG, Ramadan N, Mathew N, Brandes JL, Bigal M, Saper J, Ascher S, Jordan DM, Greenberg SJ, Hulihan J; Topiramate Chronic Migraine Study Group. Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial. Headache. 2007 Feb;47(2):170-80. doi: 10.1111/j.1526-4610.2006.00684.x.

    PMID: 17300356BACKGROUND

  • Tobin JA, Flitman SS. Occipital nerve blocks: effect of symptomatic medication: overuse and headache type on failure rate. Headache. 2009 Nov-Dec;49(10):1479-85. doi: 10.1111/j.1526-4610.2009.01549.x.

    PMID: 19912347BACKGROUND

MeSH Terms

Conditions

Headache Disorders, SecondaryHeadache

Interventions

Topiramate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Results Point of Contact

Title
Mustafa Ceylan
Organization
Ataturk University
drmuson16@hotmail.com
+905062773216

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvastigator

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 6, 2018

Study Start

March 1, 2019

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

January 22, 2020

Results First Posted

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)