CLINICAL TRIALS PROFILE FOR IMITREX
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All Clinical Trials for IMITREX
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00399243 ↗ | Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache | Unknown status | GlaxoSmithKline | Phase 4 | 2006-11-01 | 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 | 2006-11-01 | 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 | 2007-11-01 | 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 | 2007-02-01 | 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 | 2004-11-01 | 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. |
| NCT00650247 ↗ | Food Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg | Completed | Mylan Pharmaceuticals | Phase 1 | 2004-11-01 | 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 administered under fed conditions. |
| NCT00723983 ↗ | Phase I, Open Label, Single-Dose, Four Way Crossover Study to Compare the PK of NP101 With Oral Imitrex® (50mg) in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period | Completed | NuPathe Inc. | Phase 1 | 2008-11-01 | To compare the pharmacokinetics of NP101 with a currently approved oral formulation of Imitrex® (50 mg) in migraine subjects both during an acute migraine attack and during a non-migraine period. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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