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Sponsored by: |
NuPathe Inc. |
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Information provided by: | NuPathe Inc. |
ClinicalTrials.gov Identifier: | NCT00723983 |
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.
Condition | Intervention | Phase |
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Migraine Disorders |
Drug: Sumatriptan succinate Drug: NP101 Study Patch |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Phase I, Open Label, Single-Dose, Four-Way Crossover Study Comparing the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) With an Oral Formulation of Imitrex® (50mg) in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period |
Estimated Enrollment: | 36 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Period 1: Active Comparator
Subject dosed with oral sumatriptan succinate during an acute migraine attack.
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Drug: Sumatriptan succinate
Sumatriptan succinate 50 mg taken orally
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Period 2: Active Comparator
Subject dosed with oral sumatriptan during a non-migraine period.
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Drug: Sumatriptan succinate
Sumatriptan succinate 50 mg taken orally
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Period 3 and Period 6: Experimental
Subject dosed with NP101 during an acute migraine attack.
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Drug: NP101 Study Patch
NP101 study patch 4 hour application
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Period 4 and Period 5: Experimental
Subject dosed with NP101 study patch during a non-migraine period.
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Drug: NP101 Study Patch
NP101 study patch 4 hour application
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | NuPathe Inc. ( Angel S. Angelov, MD, Senior Medical Director ) |
Study ID Numbers: | PROT-15-NP101-011 |
Study First Received: | July 25, 2008 |
Last Updated: | June 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00723983 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Serotonin Agonists Neurotransmitter Agents Central Nervous System Diseases Headache Disorders, Primary Cardiovascular Agents Brain Diseases Serotonin |
Headache Disorders Sumatriptan Oxymetazoline Migraine Disorders Phenylephrine Headache Vasoconstrictor Agents |
Serotonin Agonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Headache Disorders, Primary Cardiovascular Agents |
Brain Diseases Pharmacologic Actions Headache Disorders Sumatriptan Serotonin Agents Migraine Disorders Therapeutic Uses Vasoconstrictor Agents |