Study ID |
Treatment |
General |
Nausea ± vomiting |
Local reaction |
Pain/stiffness/ tightness |
Temperature sensation |
Feeling of heaviness |
Dizziness |
Somnolence |
Bahra 2000 |
(1) Zolmitriptan 5 mg oral, n = 114
(2) Zolmitriptan 10 mg oral, n = 111
(3) Placebo, n = 115 |
Detailed list (ITT pop not safety pop) for pts with specific events occurring in > 2%, and all chest symptoms |
(1) 6/114
(2) 4/111
(3) 2/115 |
Paresthesia (NB oral route):
(1) 3/114
(2) 11/111
(3) 7/115
Most common AE |
Pain:
(1) 2/114
(2) 6/111
(3) 4/115
Tightness:
(1) 3/114
(2) 4/111
(3) 2/115 |
Sweating:
(1) 0/114
(2) 4/111
(3) 0/115 |
(1) 3/114
(2) 6/111
(3) 0/115 |
(1) 4/114
(2) 4/111
(3) 1/115 |
(1) 4/114
(2) 3/111
(3) 2/115 |
Cittadini 2006 |
(1) Zolmitriptan 5 mg IN, n = 65
(2) Zolmitriptan 10 mg IN, n = 63
(3) Placebo, n = 61 |
No details of specific AEs |
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Ekbom 1991 |
(1) Sumatriptan 6 mg SC, n = 39
(2) Placebo, n = 39
Not self‐administered (phys/nurse) |
Primarily two types:
1. injection site reactions (pain, swelling, burning, erythema, tingling) 11/39, 7/39
2. neurologic symptoms(dizziness, tiredness, numbness of hands, tingling, paraesthesia, feeling of paralysis of face, cold and hot sensations) 12/39, 8/39 |
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Ekbom 1993 |
(1) Sumatriptan 6 mg SC, n = 92
(2) Sumatriptan 12 mg SC, n = 88
(3) Placebo, n = 88
Not self‐administered (phys/nurse) |
14 events of severe intensity (injection site reaction, flushing, sweating, warm sensation, malaise/fatigue, prickling sensation)
Chest symptoms mild or moderate, resolve ≥ 30 min (pressure 2 suma 6 mg, tightness 1 suma 6 mg and 1 suma 12 mg)
AEs in ≥ 5% of participants |
(1) 5/101
(2) 6/94
(3) 1/96 |
Injection site reaction:
(1) 7/101
(2) 9/94
(3 4/96 |
(1) 1/101
(2) 5/94
(3) 0/96 |
(1) 5/101
(2) 3/94
(3) 1/96 |
(1) 5/101
(2) 5/94
(3) 1/96 |
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Rapoport 2007 |
(1) Zolmitriptan 5 mg IN, n = 52
(2) Zolmitriptan 10 mg IN, n = 49
(3) Placebo, n = 50 |
Mild, nonspecific, typical of triptan sensations |
(1) 0/52
(2) 2/49
(3) 0/50 |
Bad taste:
(1) 8/52
(2) 11/49
(3) 5/50
Discomfort of nasal cavity:
(1) 4/52
(2) 6/49
(3) 3/50 |
Throat:
(1) 1/52
(2) 2/49
(3) 1/50
Chest:
(1) 1/52
(2) 1/49
(3) 0/50
Neck:
(1) 2/52
(2) 2/49
(3) 0/50 |
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(1) 2/52
(2) 2/49
(3) 1/50 |
(1) 3/52
(2) 4/49
(3) 2/50 |
Van Vliet 2003 |
(1) Sumatriptan 20 mg IN, n = 77
(2) Placebo, n = 77 |
Very limited data |
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Bitter taste:
(1) 21%
(2) 1%
(most common event) |
Chest pressure:
(1) 2/77
(2) 0/77 |
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IN ‐ intranasal; n ‐ number of participants; pts ‐ participants; SC ‐ subcutaneous |