The TARGET Study

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study EvaluaTing the EfficAcy and Safety of a Single 20 mg Dose of SumatRiptan Powder Delivered Intranasally with the Bi-directional Device in Adults With Acute MGrainE With or WiThout Aura

Purpose: The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN device can reduce the pain and symptoms associated with migraine headaches.

Study Type: Interventional

Study Design: This study is a Phase III, randomized, double-blind, placebo-controlled parallel group study of approximately 200 subjects (100 in each treatment group) across 15 sites in the U.S. The study will be comprised of both male and female subjects, 18-65 years of age with a diagnosis of acute migraine with or without aura.

The primary objective of the study is to evaluate headache relief at 120 minutes following a dose of 20 mg of sumatriptan delivered using the OptiNose device, compared with placebo, in the acute treatment of a single migraine attack.

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of a Single 20 mg Dose of Sumatriptan Powder Delivered Intranasally with the Bi-directional Device in Adults with Acute Migraine With or Without Aura

Rationale for the Trial

During migraine attacks gastric emptying is delayed. As a consequence, tablets may not be as effective as parenteral therapies in treating a migraine attack. Intranasal formulations of some triptans (sumatriptan, zolmitriptan) have been developed with the intent of achieving faster onset of action, while avoiding the need to inject the drug. The recommended dose of sumatriptan nasal spray, using a currently available nasal spray delivery system, is 20 mg for adults. The efficacy of the nasal spray is intermediate between tablets and subcutaneous injection; the time to onset of action is about 60 minutes (Ryan 1997). Approximately 64% of patients with acute migraine treated with sumatriptan nasal spray reported achieving pain relief within 2 hours (Peikert 1999).

Current nasal sprays deliver most of the dose to the anterior third of the nose in front of the nasal valve. The remainder passes along the floor of the nose to be swallowed (Djupesland 2006), often producing an unpleasant taste. The bi-directional delivery device produces a closed soft palate and air flow directed entirely through one side of the nasal cavity around the posterior nasal septum and back through the other nostril. This has the potential to promote exposure to more areas within the nose and reduce the amount of drug that is swallowed (for further details, see the IB).

In a recently completed Phase II trial, OPTINOSE SUMATRIPTAN 10 mg and 20 mg administered via the bi-directional delivery device was highly effective in treating a single migraine attack. Treatment with the bi-directional delivery device was safe and very well tolerated.

This Phase III trial is designed to confirm the efficacy and safety of 20 mg OPTINOSE SUMATRIPTAN versus placebo delivered using the bi-directional delivery device in adults with acute migraine with or without aura.

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For more information please visit www.clinicaltrial.gov