Sphenopalatine Nerve Block for Headache Tx360

NCT01939314 | Completed Phase 3 Results

• 2 other identifiers: TX 360 HA -SchafferTian Medical Inc.
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.

Conditions

Headache; Migraine

Keywords

Headache; Migraine

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale

  15 minutes from dose

Secondary Outcomes (2)

• Categorical Pain Relief

  15 minutes from dose

• Headache Free at 24 Hours

  24 hours

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

Bupivicaine .03ml to each nare

Drug: Bupivacaine

Normal Saline

PLACEBO COMPARATOR

normal saline .03 ml to each nare

Drug: Placebo

Interventions

Bupivacaine DRUG

Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion

Bupivacaine

Placebo DRUG

Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion

Also known as: Normal Saline

Normal Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are 18 - 65 years of age
• present to emergency department (ED) triage with chief complaint of crescendo-onset anterior/frontal headache (affecting frontal, temporal, orbital, maxillary, and mandible region)
• have a normal neurological exams

You may not qualify if:

• are less than 18 years old or greater than 65
• have any focal neurological dysfunction signs or symptoms
• have a posterior/occipital/cervicogenic source predominance of headache
• are febrile (oral temperature 37.7 C or 100 F) or signs of acute or chronic sinusitis, such as congestion, has been present more than 10 days, there is a high fever, the nasal mucus is an abnormal color, or complains of face pain or headaches
• have self treated with pain medication or anti-emetic 4 hours prior to arrival
• have a history of peripheral vascular disease, cancer, or HIV infection
• are known to be pregnant

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Jason Schaffer, MD
• Organization: Indiana University School of Medicine

jtschaff@iupui.edu

317-962-8026

Study Officials

• Jason T Schaffer, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 11, 2013
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 27, 2015
• Results First Posted: July 27, 2015

Record last verified: 2015-07

Locations

US (1)