Prophylactic treatment of vestibular migraine with metoprolol

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2009
INTERVENTION: The trial comprises of two arms: 1. Therapy with metoprolol 95 mg per day 2. Placebo The total treatment time will be six months with a three month follow‐up. The trial is estimated to last four years (first patient in to last patient out). CONDITION: Vestibular migraine ; Nervous System Diseases ; Migraine PRIMARY OUTCOME: The number of vertigo attacks and number of migraine attacks during the last 3 months of the 6‐month treatment period SECONDARY OUTCOME: 1. Number of vertigo attacks during the last 3 months of the total follow‐up period of 9 months; 2. Median duration and severity of vertigo attacks during the last 3 months of the 6‐month treatment period and the last 3 months of the total follow‐up period; 3. Number of headache days per month during the last 3 months of the 6‐month treatment period and the last 3 months of the total follow‐up period; 4. Change of peripheral vestibular function and handicap/impairment due to vertigo between baseline, 6‐month visit and 9‐month visit INCLUSION CRITERIA: 1. Diagnosis of definite vestibular migraine according to the criteria of Neuhauser et al. 2001: 1.1. Episodic vestibular symptoms of at least moderate severity (rotational vertigo, other illusory self or object motion, positional vertigo, head motion intolerance, i.e., sensation of imbalance or illusory self or object motion that is provoked by head motion) 1.2. Migraine according to the International Headache Society (IHS) criteria 1.3. At least one of the following migrainous symptoms during at least two vertiginous attacks: migrainous headache, photophobia, phonophobia, visual or other auras 1.4. Other causes ruled out by appropriate investigations 2. At least two attacks per month for at least 3 subsequent months 3. Aged 18 to 80 years, either sex 4. Written informed consent, signed and dated by the patient (or patient's authorised representative) and by the person obtaining the consent, indicating agreement to comply with all protocol‐spec
Epistemonikos ID: 2f5fa0956653ffa4c7e22bb04ca427cc7b4a3f56
First added on: Aug 21, 2024