Primary Headache DisordersNCT02392273
A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil
An observational study of Primary Headache Disorders, run by VR1 Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Headache Disorders
- What is being tested?
- Ausanil
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in a Clinical headache practice (outpatient) with a diagnosis of a primary headache disorder.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantic Health System/Overlook Medical Center Medical Arts Center
Summit, New Jersey, 07901
About this study
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
- Being tested
- Ausanil
- Keywords
- migraine, cluster headache, primary headache, Ausanil, capsicum annuum
- Medical subject headings
- Headache Disorders, Primary, Migraine Disorders, Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AusanilDrug
Also called capsicum annuum
Patients with Primary Headache disorders will receive Ausanil in the context of usual and routine clinical care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (all cause)
Patient/Physician reporting
Measured: 8 weeks
Incidence of Adverse Events causally related to Ausanil
Patient/Physician reporting
Measured: 8 weeks
Serious Adverse Events
Patient/Physician reporting
Measured: 8 weeks
Secondary outcomes (6)
Headache Response to Ausanil
Change in Headache severity on a four point scale (0-3) will be measured at 5 minutes, one hour, two hours and twenty four hours
Measured: 24 hours
Functional Assessment
Improvement in ability to function after Headache treatment
Measured: 24 Hours
Patient satisfaction for Treatment
Patients will be asked to rate their satisfaction with treatment on a 7 point scale (very dissatisfied to very satisfied)
Measured: 24 hours
Time Loss to headache
How many hours of function were lost as result of the headache?
Measured: 24 hours
Use of Rescue Medication
Frequency of Rescue medication will be tabulated
Measured: 24 hours
Sting severity and duration
How long does the sting associated with Ausanil treatment last?
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Why it stopped: Study unable to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Headache DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VR1 Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seth Stoller, MD, Principal investigator, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392273
- Sponsor's protocol ID
- Ausanil Study 001
- Status last verified
- Dec 2016
- First submitted
- 12 Mar 2015
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil
- ClinicalTrials.gov ID
- NCT02392273
- Acronym / sponsor ID
- Ausanil Study 001
- Conditions
- Primary Headache Disorders
- Keywords
- migraine, cluster headache, primary headache, Ausanil, capsicum annuum
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study unable to recruit
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VR1 CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in a Clinical headache practice (outpatient) with a diagnosis of a primary headache disorder.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AusanilAlso: capsicum annuumPatients with Primary Headache disorders will receive Ausanil in the context of usual and routine clinical care. | Drug | – |
Primary outcome
Incidence of Adverse Events (all cause)
Time frame: 8 weeks
Patient/Physician reporting
Incidence of Adverse Events causally related to Ausanil
Time frame: 8 weeks
Patient/Physician reporting
Serious Adverse Events
Time frame: 8 weeks
Patient/Physician reporting
6 secondary outcomes
Headache Response to Ausanil
Time frame: 24 hours
Functional Assessment
Time frame: 24 Hours
Patient satisfaction for Treatment
Time frame: 24 hours
Time Loss to headache
Time frame: 24 hours
Use of Rescue Medication
Time frame: 24 hours
Sting severity and duration
Time frame: one hour
Results and safety
The study was stopped early (reason given: Study unable to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
Related trials for Primary Headache Disorders
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth Stoller, MD principal investigator
Atlantic Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Headache Disorders, run by VR1 Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study unable to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (all cause) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.