Flunarizine in Prophylaxis of Childhood Migraine: A Double-Blind, Placebo-Controlled, Crossover Study

Sorge, F; Simone, Roberto De; Marano, E; Nolano, Maria; Orefice, G; Carrieri, P

doi:10.1046/j.1468-2982.1988.0801001.x

Cited by 1,654 publications

(88 citation statements)

References 14 publications

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“…The side effect profile in this cohort was more or less similar to that seen in previous adult and paediatric studies. 12,16 In terms of efficacy, 57% of children in the cohort benefited by way of reduction in attack frequency. This is comparable to the outcome data already available from adult and paediatric studies.…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of flunarizine in childhood migraine: 11 years’ experience, with emphasis on its effect in hemiplegic migraine

Mohamed

Goadsby

Prabhakar

2012

Develop Med Child Neuro

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AIM The aim of this study was to report a single-centre experience of flunarizine in childhood migraine with focus on safety and efficacy.METHOD We conducted a retrospective observational audit of 72 individuals (40 male, 32 female; mean age 13y; age range 1y 6mo-17y) at a tertiary paediatric neurology unit between 1998 and 2009. Children were included if they had a diagnosis of migraine and at least one follow-up assessment and a minimum of 3 months' treatment with flunarizine. RESULTSOf 102 individuals identified, 30 were excluded for the following reasons: no outcome data (n=13), non-migraineurs (n=9), missing records (n=4), or inadequate treatment duration (n=4). Of the final cohort (72 individuals), 44 had migraine without aura, 15 had migraine with aura or childhood migraine equivalents, eight had sporadic hemiplegic migraine, and five had familial hemiplegic migraine. The median age was 13 years (1y 6mo-17y) and median duration of migraine was 48 months. Starting dose was 5mg. Other doses used were 2.5mg (three individuals), 7.5mg (one individual), and 10mg (six individuals). Treatment duration was 12 months. Successful prophylaxis, defined as at least a 50% reduction in attack frequency, was observed in 57% (41 ⁄ 72). Response rate was higher among those with hemiplegic migraines (85%) than in those who did not have hemiplegic migraines (51%). Side effects were noted in 15 (21%) individuals (depression, n=6; weight gain ⁄ increased appetite, n=5; tiredness ⁄ sedation, n=2; and worsening headache, n=2), and led to discontinuation of treatment in 13.

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Section: Discussionmentioning

confidence: 99%

Safety and efficacy of flunarizine in childhood migraine: 11 years’ experience, with emphasis on its effect in hemiplegic migraine

Mohamed

Goadsby

Prabhakar

2012

Develop Med Child Neuro

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“…45 Only two of the trials detailed side effects, which included sedation (9.5%) and weight gain (22.2%) but extrapyramidal side effects (e.g., tremor) have been reported in postmarketing trials. 42,43 Conclusions. The calcium channel blocker flunarizine was studied in one class I trial and is probably effective but is unavailable in the United States.…”

Section: Description Of Processmentioning

confidence: 98%

“…A double blind, placebo-controlled, crossover trial (class I) using 5 mg/day doses of flunarizine (n ϭ 63) demonstrated significant reduction in headache frequency (p Ͻ 0.001) and decreased average headache duration (p Ͻ 0.01) compared to the placebo group. 42 The main side effects were drowsiness (9.5%) and weight gain (22.2%). …”

Section: Description Of Processmentioning

confidence: 99%

Practice Parameter: Pharmacological treatment of migraine headache in children and adolescents [RETIRED]

et al. 2004

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Abstract-Objective:To review evidence on the pharmacologic treatment of the child with migraine headache. Methods: The authors reviewed, abstracted, and classified relevant literature. Recommendations were based on a four-tiered scheme of evidence classification. Treatment options were separated into medications for acute headache and preventive medications. Results: The authors identified and reviewed 166 articles. For acute treatment, five agents were reviewed. Sumatriptan nasal spray and ibuprofen are effective and are well tolerated vs placebo. Acetaminophen is probably effective and is well tolerated vs placebo. Rizatriptan and zolmitriptan were safe and well tolerated but were not superior to placebo. For preventive therapy, 12 agents were evaluated. Flunarizine is probably effective. The data concerning cyproheptadine, amitriptyline, divalproex sodium, topiramate, and levetiracetam were insufficient. Conflicting data were found concerning propranolol and trazodone. Pizotifen, nimodipine, and clonidine did not show efficacy. Conclusions: For children (Ͼage 6 years), ibuprofen is effective and acetaminophen is probably effective and either can be considered for the acute treatment of migraine. For adolescents (Ͼ12 years of age), sumatriptan nasal spray is effective and should be considered for the acute treatment of migraine. For preventive therapy, flunarizine is probably effective and can be considered, but is not available in the United States. There are conflicting or insufficient data to make any other recommendations for the preventive therapy of migraine in children and adolescents. For a clinical problem so prevalent in children and adolescents, there is a disappointing lack of evidence from controlled, randomized, and masked trials.

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“…Among the available medications, only flunarizine has been consistently effective in well-designed controlled trials for migraine prevention (49,50). Flunarizine is a calciumchannel blocker with the potential side effects of weight gain and sedation.…”

Section: Medicationsmentioning

confidence: 99%

The evaluation and management of paediatric headaches

Dooley

2009

Paediatrics &Amp; Child Health

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Flunarizine in Prophylaxis of Childhood Migraine: A Double-Blind, Placebo-Controlled, Crossover Study

Cited by 1,654 publications

References 14 publications

Safety and efficacy of flunarizine in childhood migraine: 11 years’ experience, with emphasis on its effect in hemiplegic migraine

Safety and efficacy of flunarizine in childhood migraine: 11 years’ experience, with emphasis on its effect in hemiplegic migraine

Practice Parameter: Pharmacological treatment of migraine headache in children and adolescents [RETIRED]

The evaluation and management of paediatric headaches

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