Clinical Trials Logo
  1. Home
  2. Migraine Headache
  3. NCT01462812

Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine

Migraine Headache Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

The primary objective for this study is to compare headache relief (defined as a reduction from moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0] or mild [Grade 1] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01462812
Study type Interventional
Source Optinose US Inc.
Contact
Status Completed
Phase Phase 3
Start date January 2011
Completion date June 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Not yet recruiting NCT05943457 - Vitamin K2 Supplementation in Adult Episodic Migraine N/A
Completed NCT01211145 - Zomig - Treatment of Acute Migraine Headache in Adolescents Phase 4
Completed NCT00530517 - A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack Phase 2
Completed NCT00898677 - Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030) Phase 3
Recruiting NCT06459635 - Migraine Attack Pain Phase Prediction Study
Completed NCT03971071 - A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache Phase 4
Withdrawn NCT02706015 - Cefaliv® Compared to Neosaldina® in the Treatment of Migraine Attacks Phase 3
Terminated NCT02375789 - Intranasal Cooling for Symptomatic Relief of Migraine N/A
Completed NCT02518464 - Ticagrelor Therapy for RefrACTORy Migraine Study Phase 4
Terminated NCT00391755 - A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches Phase 4
Completed NCT03401346 - Bioavailability of DHE Administered by I123 POD Device, IV Injection, and Migranal Nasal Spray in Healthy Adults Phase 1
Completed NCT05085483 - Ketone for Migraine Prevention N/A
Completed NCT01604785 - Low-dose Propofol for Pediatric Migraine Phase 2/Phase 3
Terminated NCT00804973 - Study in Participants With Acute Migraines Headaches Phase 2
Completed NCT03341689 - Psilocybin for the Treatment of Migraine Headache Phase 1
Completed NCT01630044 - Neurostimulation Device for Treatment of Migraine Headache N/A
Active, not recruiting NCT00285402 - Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine Phase 2
Completed NCT00203255 - Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-Associated Migraine Headache N/A
Recruiting NCT06046508 - Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)