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Generated: February 19, 2019

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CLINICAL TRIALS PROFILE FOR IMITREX

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Clinical Trials for Imitrex

Trial ID Title Status Sponsor Phase Summary
NCT00399243 Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache Unknown status GlaxoSmithKline Phase 4 This study's hypothesis is the 4mg StatDose sumatriptan is effective for the acute treatment of cluster headache and provides good safety and tolerability across multiple doses of the study medication as well as across multiple attacks of cluster headache. This study seeks to determine the safety and efficacy of the commercially available 4mg StatDose formulation of sumatriptan as an acute treatment of cluster headache. Patients are allowed to use repeated dose of the study medication for a given headache if they have had a partial response to the first dose. They may treat up to 3 attacks of cluster headache with the study medication. Safety assessment will be through adverse event reporting and physical examination. Patients with both episodic cluster headache as well as chronic cluster headache will be studied. Patients must either not have started preventive treatment for cluster headache or be on a stable dose of preventive medication.
NCT00399243 Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache Unknown status Diamond Headache Clinic Phase 4 This study's hypothesis is the 4mg StatDose sumatriptan is effective for the acute treatment of cluster headache and provides good safety and tolerability across multiple doses of the study medication as well as across multiple attacks of cluster headache. This study seeks to determine the safety and efficacy of the commercially available 4mg StatDose formulation of sumatriptan as an acute treatment of cluster headache. Patients are allowed to use repeated dose of the study medication for a given headache if they have had a partial response to the first dose. They may treat up to 3 attacks of cluster headache with the study medication. Safety assessment will be through adverse event reporting and physical examination. Patients with both episodic cluster headache as well as chronic cluster headache will be studied. Patients must either not have started preventive treatment for cluster headache or be on a stable dose of preventive medication.
NCT00546650 Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex® Completed NuPathe Inc. Phase 1 The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection. The secondary objective is to evaluate the safety of NP101 in healthy volunteers.
NCT00573599 Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department Completed United States Naval Medical Center, Portsmouth N/A ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is improvement in pain scales between the groups.
NCT00648466 Fasting Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administration under fasting conditions.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Imitrex

Condition Name

Condition Name for Imitrex
Intervention Trials
Healthy 8
Migraine 5
Migraine Disorders 3
Episodic Cluster Headache 1
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Condition MeSH

Condition MeSH for Imitrex
Intervention Trials
Migraine Disorders 8
Headache 4
Cluster Headache 1
Post-Traumatic Headache 1
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Clinical Trial Locations for Imitrex

Trials by Country

Trials by Country for Imitrex
Location Trials
United States 19
India 3
Canada 1
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Trials by US State

Trials by US State for Imitrex
Location Trials
Florida 3
Washington 2
West Virginia 2
Virginia 2
Maryland 2
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Clinical Trial Progress for Imitrex

Clinical Trial Phase

Clinical Trial Phase for Imitrex
Clinical Trial Phase Trials
Phase 4 3
Phase 2/Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Imitrex
Clinical Trial Phase Trials
Completed 18
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Imitrex

Sponsor Name

Sponsor Name for Imitrex
Sponsor Trials
GlaxoSmithKline 5
NuPathe Inc. 3
Ranbaxy Laboratories Limited 2
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Sponsor Type

Sponsor Type for Imitrex
Sponsor Trials
Industry 22
Other 6
U.S. Fed 1
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Daiichi Sankyo
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Covington
Fuji

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