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Table 1 Placebo controlled randomized clinical trials of flunarizine. trial characteristics

From: European Headache Federation (EHF) critical re-appraisal and meta-analysis of oral drugs in migraine prevention—part 2: flunarizine

Study name

Study design

Funding

Country

Sample size

Age, median (range)

% Male

Types of migraine

Drug dosage (daily)

Active Tx period (weeks)

Outcome measures

Tolerability

dLouis 1981 [21]

PCS

NR

Belgium

58

(29 in each arm)

29

(20–47)

50

Common migraine (31%)

or

Classical migraine (69%)a

10 mg

12

Reduction in:

• Monthly migraine attacks

(at least one attack at 3rd mo: 17.2% vs 55.2%, p = 0.006)

• Duration and severity of migraine attacks, did not differ between two interventions

Mild day-time sedation in 2 patients on flunarizine

(without withdrawal)

Dry mouth; in 2 controls

(without withdrawal)

dSørensen 1986 [24]

PCS, Cross-over

NR

Denmark

29e

40

(19–63)

20.7

Common migraineb

10 mg

16

Reduction in:

• Monthly migraine attacks

(reduction in number of attacks at 4th mo: 50% vs 15%, p = 0.02)

• Duration and severity of migraine attacks (p = NS, for both)

Mild day-time sedation in 3 patients on flunarizine

(1 withdrawal)

dFreitag 1991 [25]

PCS

NR

US

101

(50 in flunarizine arm)

NR

25.7

MwA (32.7%)

or

MwoA (67.3%)c

10 mg

16

Reduction in:

• Number of migraine attacks from baseline to the end

(50% vs 39.9%, p = 0.018)

• Duration and severity of migraine attacks (reduced in flunarizine arm, but p = NS for both)

5 withdrawals among patients on flunarizine††

3 withdrawals among controls

Frenken 1984 [22]

PCS

NR

Netherlands

35

(17 in flunarizine arm)

NR

17.1

Common migraine (60%)

or

Classical migraine (40%)a

10 mg

12

Reduction in:

• Monthly migraine attacks

(significant reduction in flunarizine arm; p = 0.029 at 1st mo)

• Duration of migraine attacks (p value is not reported)

• Severity of migraine attacks (p = NS)

Day-time sedation in 7, weight gain in 3 and other AEs in 2 patients on flunarizine

Day-time sedation in 3, stomach complaints in 4, and other AEs in 1 of controls

Mendenopoulos 1985 [23]

PCS

NR

Greece

20

(9 in flunarizine arm)

20–65

20

Classical migraine a

10 mg

12–16

Reduction in:

• Monthly Migraine attacks

(50% reduction in attacks after 3 mo; p = 0.033)

• Duration and severity of migraine attacks

(significant reduction in flunarizine arm; p = 0.037 and p = 0.006, respectively, after 3rd month)

No AEs

  1. AEs Adverse events, FU Follow-up, MwA Migraine with aura, MwA Migraine without aura, NR Not reported, NS not significant, PCS Prospective cohort study, Tx Treatment
  2. adefined according to the Ad Hoc Committee on Classification of Headache of the NIH [25]
  3. bdefined according to the modified criteria of the Ad Hoc Committee on the Classification of Headache by Olesen et al. [26]
  4. cdefined according to the first edition of the International Headache Classification [27]
  5. dStudies included in the meta-analysis
  6. eOne patient withdrew on placebo because of increasing number of migraine attacks
  7. fDetails of the adverse events leading to withrawal were not given in the article
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The Journal of Headache and Pain

ISSN: 1129-2377

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