A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil

NCT02392273 | Terminated

• 1 other identifier: Ausanil Study 001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an observational study with the primary objective to assess the safety and tolerability of Ausanil in the treatment of primary headache disorders. The secondary objective is to assess headache pain, functional outcome, time loss to headache and patient satisfaction with Ausanil treatment.

Conditions

Primary Headache Disorders

Keywords

migraine; cluster headache; primary headache; Ausanil; capsicum annuum

Outcome Measures

Primary Outcomes (3)

• Incidence of Adverse Events (all cause)

  Patient/Physician reporting

  8 weeks

• Incidence of Adverse Events causally related to Ausanil

  Patient/Physician reporting

  8 weeks

• Serious Adverse Events

  Patient/Physician reporting

  8 weeks

Secondary Outcomes (6)

• Headache Response to Ausanil

  24 hours

• Functional Assessment

  24 Hours

• Patient satisfaction for Treatment

  24 hours

• Time Loss to headache

  24 hours

• Use of Rescue Medication

  24 hours

Interventions

Ausanil DRUG

Patients with Primary Headache disorders will receive Ausanil in the context of usual and routine clinical care.

Also known as: capsicum annuum

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in a Clinical headache practice (outpatient) with a diagnosis of a primary headache disorder.

You may qualify if:

• Men and women aged 18 to 80 years
• Primary Headache disorder as per International Classification of Headache Disorders-11
• Ausanil naive
• Signed dated informed consent
• Females of childbearing potential must be using adequate contraception during study period.
• Willing and able to comply with registry requirements to document headache response

You may not qualify if:

• Known allergy to Ausanil or any of its ingredients
• Active bronchial asthma that in the opinion of the investigator would interfere with use of Ausanil
• Nasal obstruction due to any cause or extensive nasal surgery resulting in scarring or other such impact on nasal mucosa that might lead to heightened sensitivity to Ausanil in the opinion of the investigator.
• Pregnant or breast feeding females
• History of addictive behavior
• Any severe or chronic unstable medical or psychiatric condition
• Active nasal infection or inflammation
• Unable or unwilling to provide informed consent
• Suffer from atypical, basilar or hemiplegic migraine that is new onset or unstable.

Sponsors & Collaborators

• VR1 Corporation: lead

Study Sites (1)

Atlantic Health System/Overlook Medical Center Medical Arts Center

Summit, New Jersey, 07901, United States

Location

MeSH Terms

Conditions

Headache Disorders, Primary; Migraine Disorders; Cluster Headache

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trigeminal Autonomic Cephalalgias

Study Officials

• Seth Stoller, MD

  Atlantic Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: December 28, 2016

Record last verified: 2016-12

Locations

US (1)