Cluster HeadacheNCT01677026
Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache
An observational study of Cluster Headache, run by Autonomic Technologies, Inc. at 11 sites in 2 countries.
Trial summary
The primary objectives of the Registry are to: 1. Monitor the transfer of the ATI Neurostimulation System and its safety/clinical performance to a larger number of centers in the post market phase and 2. Collect additional evidence to support reimbursement and clinical acceptance and long term follow up Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cluster Headache
- How many people
- 150 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Sep 2012to 9 Apr 2018
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who meet the CE marked labeling for cluster headache for the ATI Neurostimulation System.
Who may be able to join
- Subject meets CE marked labeling for cluster headache.
- Subject's typical cluster headache bouts last a minimum of 16 weeks, in the opinion of the Investigator.
- Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency or dose except to manage tolerability) from Study Enrollment through the completion of the Therapy Evaluation Period.
- Subject has the ability to read, comprehend and to reliably record information as required by the Protocol.
- Subject is able to provide written informed consent prior to participation in the study.
Who cannot join
- Subject has had a change in type, dosage or frequency of taking preventive headache medications < one (1) month prior to Study Enrollment.
- Per the CE marked labeling: In the opinion of the Investigator, subject has bony facial deformities, inappropriate surgical anatomy or has had facial surgery in the surgical area on the same side as the planned surgery that would prevent the proper placement of the ATI Neurostimulator.
- Subject has other significant pain problem that might confound the study assessments in the opinion of the Investigator.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Germany10 sites
Berlin Charite Hospital
Berlin, 10117
Neurologische Klinik und Poliklinik
Bochum, 44789
Headache Center, Dept. Of Neurology, Univ. Duisburg-Essen
Essen, 45147
Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246
Universitatsklinikum Jena Klinik f. Neurologie
Jena, 07747
Klinik fur Mund-, Kiefer-und Gesichtschirurgie, Rotes
Kassel, 34121
Migraine- und Kopfschmerzklinik Konigstein
Königstein, D-61462
Neurologie & Kopfschmerzzentrum Munchner Freiheit
Munich, 80802
University of Munich-Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik
Munich
Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie
Münster, 48149
About this study
The primary objectives of the Registry are to:
- Monitor the transfer of the ATI Neurostimulation System and its safety/clinical performance to a larger number of centers in the post market phase and
- Collect additional evidence to support reimbursement and clinical acceptance and long term follow up
- Conditions
- Cluster Headache
- Medical subject headings
- Cluster Headache
What is being measured
The primary outcome is the main question the study is designed to answer.
Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following:
- Implantation of ATI Neurostimulator within the pterygopalatine fossa
- Explant and lead-revision rates and reasons
Measured: Through study completion
Characterization of patient response to therapy, as evaluated by the following:
- Patient acceptance of the therapy
- Responder Analysis, where a responder is any patient who achieves Effective Therapy in at least 50% of evaluable attacks, a 50% attack frequency attack decrease relative to Baseline, or both
- Disability and Quality of Life as characterized by the HIT-6 and SF-36v2 compared to Baseline
- Subject Overall Evaluation of Therapy
- Change in use of acute medications compared to Baseline
- Change in preventive medication use and work status compared to Baseline
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startSep 2012
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies 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
- 150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Autonomic Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arne May, MD, PhD, Principal investigator, Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677026
- Sponsor's protocol ID
- CP-004
- Status last verified
- Jun 2018
- First submitted
- 29 Aug 2012
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache
- ClinicalTrials.gov ID
- NCT01677026
- Acronym / sponsor ID
- CP-004
- Conditions
- Cluster Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Autonomic Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 31 Aug 2012 (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.
The primary objectives of the Registry are to:
- Monitor the transfer of the ATI Neurostimulation System and its safety/clinical performance to a larger number of centers in the post market phase and
- Collect additional evidence to support reimbursement and clinical acceptance and long term follow up
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who meet the CE marked labeling for cluster headache for the ATI Neurostimulation System.
Key inclusion criteria (5 listed)
- Subject meets CE marked labeling for cluster headache.
- Subject's typical cluster headache bouts last a minimum of 16 weeks, in the opinion of the Investigator.
- Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency or dose except to manage tolerability) from Study Enrollment through the completion of the Therapy Evaluation Period.
- Subject has the ability to read, comprehend and to reliably record information as required by the Protocol.
- Subject is able to provide written informed consent prior to participation in the study.
Key exclusion criteria (3 listed)
- Subject has had a change in type, dosage or frequency of taking preventive headache medications < one (1) month prior to Study Enrollment.
- Per the CE marked labeling: In the opinion of the Investigator, subject has bony facial deformities, inappropriate surgical anatomy or has had facial surgery in the surgical area on the same side as the planned surgery that would prevent the proper placement of the ATI Neurostimulator.
- Subject has other significant pain problem that might confound the study assessments in the opinion of the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following:
Time frame: Through study completion
1. Implantation of ATI Neurostimulator within the pterygopalatine fossa 2. Explant and lead-revision rates and reasons
Characterization of patient response to therapy, as evaluated by the following:
Time frame: Through study completion
1. Patient acceptance of the therapy 2. Responder Analysis, where a responder is any patient who achieves Effective Therapy in at least 50% of evaluable attacks, a 50% attack frequency attack decrease relative to Baseline, or both 3. Disability and Quality of Life as characterized by the HIT-6 and SF-36v2 compared to Baseline 4. Subject Overall Evaluation of Therapy 5. Change in use of acute medications compared to Baseline 6. Change in preventive medication use and work status compared to Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
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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.
Arne May, MD, PhD principal investigator
Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cluster Headache, run by Autonomic Technologies, Inc. at 11 sites in 2 countries.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following: (time frame: Through study completion). The study lists 2 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 26 Jun 2018.