Therapeutic Efficacy of Botulinum Toxin Type A in Patients with Vestibular Migraine

BOTOX for treatment of vestibular migraine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0006974

Enrollment

Registered

2022-02-03

Start date

2020-11-16

Completion date

Unknown

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patients were treated with BTX-A (BOTOX®, Allergan, Inc., Irvine, CA, USA) injections based on the PREEMPT (Phase 3 Research Evaluating Migraine Prophylaxis Therapy) injection paradigm of fixed

a total of 155U was injected (5U each into 31 designated sites corresponding to 7 muscles of the head and neck areas

The anatomic injection sites follow distributions and areas innervated by the trigeminal nerve complex. Anterior injection on corrugator, proceus, and frontalis. Lateral injection on temporalis. Poste

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients at a dizziness clinic of Jeonbuk National University Hospital, Korea, who were diagnosed with vestibular migraine(VM) using the criteria of the Headache Classification Committee of the International Headache Society (ICHD-3, appendix) and the Committee for the International Classification of Vestibular Disorders of the Bárány Society were considered for inclusion in the current study between May 2020 and January 2021. Twenty right-handed VM patients were included who suffered from moderate-to-severe vertigo attacks with migraine headache, with moderate impairment in daily life, despite treatment with several preventive drugs for at least 5 months. The use of migraine prophylactics was permitted if no changes in medications or dosages were made within the two months of study participation.

Exclusion criteria

Exclusion criteria: Those who have a disease that can affect neuromuscular function, such as myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or motor neuron disease are not suitable for Botox treatment, or have been diagnosed with another primary or secondary headache disease, and patients judged unsuitable for participation in this study by the investigators were excluded.

Design outcomes

Primary

Measure	Time frame
Migraine disability assessment, Visual analog scale, Vertigo symptom scale	—

Secondary

Measure	Time frame
Headache impact test-6, Migraine specific quality of life, Dizziness handicap inventory, Beck Depression Inventory, Beck's Anxiety Inventory	—

Countries

Korea, Republic of

Contacts

Public ContactJin-Ju Kang

Jeonbuk National University Hospital

jinj_k@naver.com+82-63-250-1590

Outcome results