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Zomig™ (zolmitriptan) Clinical Trial report summaries

Zomig™ (zolmitriptan) is an oral, selective 5-hydroxytryptamine 1B/1D

(5-HT 1B/1D ) receptor agonist or 'triptan' for acute treatment of migraine attacks with or without aura. 

Please consult the prescribing information for the country concerned for guidance on the approved use of Zomig™ (zolmitriptan).

Study Number Completed Clinical Trial Report Summaries

311CIL/0070

A Randomised, Double-Blind, Parallel Group Multicentre Trial to Compare the Efficacy and Safety of Zolmitriptan 2.5 mg, Zolmitriptan 5.0 mg and Sumatriptan 50 mg in the Treatment of Migraine Headache (311CIL/0070 [ZEUS]) (6-Attack Analysis).

311CIL/0077

A Randomised, Double-Blind, Double-Dummy, Parallel Group, Multicentre Trial to Compare the Efficacy and Safety of Four Fixed Doses of Intranasal Zolmitriptan with an Oral Dose of Zolmitriptan and Placebo in Patients with Migraine Headache.

311CIL/0081

An Open, Randomised, Parallel-Group, Multicentre Trial to Compare the Efficacy of a Stratified Treatment Regimen for Acute Migraine Attacks, in whichPatients Receive Therapy According to the Grade of their Migraine Disability at Baseline, Assessed by the MIDAS Questionnaire, with that of 2 Other Treatment Regimens, in which Patients Receive Standard Therapy that may be altered after 3 Attacks (Stepped Care) or within Individual Attacks (Staged Care).

311CIL/0099

A Multicentre, Randomised, Double-Blind Trial to Compare the Efficacy and Safety of ZOMIG 2.5 mg, NARAMIG 2.5 mg and Placebo in the Acute Treatment of AdultPatients with Migraine.

311CIL/0107

An International, Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Efficacy and Tolerability of ZOMIG™2.5 mg (Orally Dispersible Tablet) in theAcute Treatment of Adult Patients with Migraine (311CIL/0107).

NOTE: The orally dispersible tablet will be discussed hereafter as the orally disintegrating tablet.

311CIL/0111

A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy of Oral Zolmitriptan 2.5 mg in the Acute Treatment of Migraine During the Mild Intensity Phase of an Attack in Patients Highly Disabled by Migraine (MIDAS Grades III and IV) (311CIL/0111).
311CIL/0114A Multicentre, Open, Crossover Study to Evaluate Preference for either Zolmitriptan (2.5mg) Orally Dispersible Tablet or Sumatriptan (50 mg) Tablet for the Acute Treatment of Migraine in Adult Patients.

311CIL/0120

REALIZE (Real Life Intranasal Zolmitriptan Exposure study)A Multinational, Multicentre, Two Phase Study to Assess the Efficacy of and Satisfaction with Intranasal Zolmitriptan 5 mg in the Acute Treatment of Migraine When Taken as Required by the Patients, by Single Attack Comparison to Placebo and an Open Extension of Three Attacks.

311CUS/0005

A Multicenter, Double-blind, Placebo-controlled, Randomized Study and Open-label, Long-term, Tolerability Study with Zolmitriptan (Zomig™) forthe Acute Treatment of Migraine Headaches in Adolescent Patients (Full Safety and Abbreviated efficacy).

 311CUS/0022

 A Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Early Efficacy and Tolerability of Zolmitriptan (ZOMIG®) Nasal Spray in the Acute Treatment of Adult Subjects with Migraine.

 311CUS/0016

 A Multicenter, Randomized, Open-label Comparison of the Effects of ZOMIG-ZMT® (zolmitriptan) and Usual Non-triptan Migraine Care on Work Loss, Productivity, and Patient Preference.

 311CUS/0012

 An Open, Randomized, Parallel-Group, Multicenter Study to Compare a Stratified Care Treatment Regimen based on Migraine Disability (MIDAS grade) versus Standard Therapy for the Acute Treatment of Migraine Headache.

 311CUS/0003

 A Multicenter, 2-phase, Double-blind, Randomized, Placebo-controlled, Parallel Trial to Evaluate the Efficacy of a Single Dose of Zolmitriptan (ZOMIG®) as Acute Treatment in Phase I and Repeated Doses as Preemptive Treatment in Phase II for Menstrual Migraine Headache.

 D1221C00005

 A Multicenter, Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study with a Single-blind, Placebo-challenge to Evaluate the Efficacy of Zolmitriptan 5-mg Nasal Spray in the Treatment of Acute Migraine Headache in Adolescents.

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