A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Headache Disorders

Keywords

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migraine cluster headache primary headache Ausanil capsicum annuum

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Ausanil

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

Intervention Type DRUG

Other Intervention Names

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capsicum annuum

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seth Stoller, MD

Role: PRINCIPAL_INVESTIGATOR

Atlantic Health System

Locations

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Atlantic Health System/Overlook Medical Center Medical Arts Center

Summit, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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Ausanil Study 001

Identifier Type: -

Identifier Source: org_study_id