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Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03767062
Recruitment Status : Completed
First Posted : December 6, 2018
Results First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Mustafa Ceylan, Ataturk University

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.


Condition or disease Intervention/treatment Phase
Medication Overuse Headache Chronic Migraine, Headache Drug: Topamax Procedure: Greater Occipital Nerve Block + Supratrochlear Nerve Block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Effects of Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches: A Randomised Parallel Group Study
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
Drug Information available for: Topiramate

Arm Intervention/treatment
Active Comparator: Topiramate
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
An antiepileptic agent used for migraine prophylaxis.

Active Comparator: Greater Occipital +Supratrochlear Nerve Block
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
An injection to paralyze the occipital and supratrochlear nerves.




Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: Post treatment (4 weeks later) ]
    Range Pain 0-10, 0: No pain, 10: Worst Pain

  2. Attack Frequencies [ Time Frame: Post treatment (4 weeks later) ]
    Number of headaches patients suffer in a month.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chronic migraine diagnosis according to International Classification of Headache-2 Disorders (ICHD)
  2. w/o pregnancy or breastfeeding.
  3. w/o acute or chronic psychiatric disorders.
  4. w/o nephrolithiasis.
  5. w/o medication of anticoagulant and antiaggregant.
  6. w/o allergy to topiramate or bupivacaine.
  7. w/o prophylaxis within the last three months with any of; propranolol, nebivolol, topiramate, valproate, venlafaxine, duloxetine, amitriptyline, flunarizine.
  8. w/o previous history of peripheral nerve block, botulinum toxin or acupuncture.
  9. 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767062


Locations
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Turkey
Mustafa Ceylan
Erzurum, Turkey, 25000
Sponsors and Collaborators
Ataturk University
  Study Documents (Full-Text)

Documents provided by Mustafa Ceylan, Ataturk University:
Publications:
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Responsible Party: Mustafa Ceylan, Principal İnvastigator, Ataturk University
ClinicalTrials.gov Identifier: NCT03767062    
Other Study ID Numbers: 2018/22-3
First Posted: December 6, 2018    Key Record Dates
Results First Posted: January 22, 2020
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mustafa Ceylan, Ataturk University:
Medication overuse headache; Greater occipital nerve block; supratrochlear nerve block; topiramate.
Additional relevant MeSH terms:
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Headache Disorders, Secondary
Headache
Pain
Neurologic Manifestations
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs