Cluster HeadacheSERNCT02440776
Pathway CH S&E Registry
An observational study of Cluster Headache, run by Autonomic Technologies, Inc. at 9 sites in 5 countries.
Trial summary
Monitor the safety and performance of the Pulsante Microstimulator System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cluster Headache
- How many people
- 30 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Apr 2015to 30 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who meet the CE marked labeling for cluster headache for the Pulsante Microstimulator System
Who may be able to join
- Patient meets CE marked labeling for cluster headache.
- Patient has the ability to read, comprehend and reliably record information as required by the Protocol.
- Patient is able to provide written informed consent prior to participation in the study.
Who cannot join
- 1. Patient has other significant pain problem that might confound the study assessments in the opinion of the Investigator.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Germany5 sites
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie
Dresden, 01307
Heinrich-Heine-University
Düsseldorf, D-40225
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Klinik für Schmerztherapie, Rotes Kreuz Krankenhaus, Hansteinstr. 29
Kassel, 34121
Neurologie + Kopfschmerzzentrum Münchner Freiheit
Munich, 80802
Sweden1 site
Neurologiska Kliniken-Karolinska UniversitetssjukhusetSolna
Stockholm, 17176
Switzerland1 site
University Hospital Zurich, Klinik f. Neurologie, Frauenklinikstr. 26
Zurich, 8091
About this study
Official title: Pathway CH S&E Registry: Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache - ATI Neurostimulation System is Branded Internationally as Pulsante™ Microstimulator System
Monitor the safety and performance of the Pulsante Microstimulator System.
- 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.
Characterization of all device/procedure related Adverse Events
Outcome will be assessed at Implant, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant.
Measured: Through five years post implant
Secondary outcomes (1)
Acute response to therapy
Outcome will be assessed at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant.
Measured: Through five years post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startApr 2015
- Primary completion13 May 2018
- Study completion30 Jun 2018 (estimated)
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
- 30 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Autonomic Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440776
- Sponsor's protocol ID
- CP-010
- Acronym
- SER
- Status last verified
- Jun 2018
- First submitted
- 6 May 2015
- 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
- Pathway CH S&E Registry: Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache - ATI Neurostimulation System is Branded Internationally as Pulsante™ Microstimulator System
- ClinicalTrials.gov ID
- NCT02440776
- Acronym / sponsor ID
- SER / CP-010
- Conditions
- Cluster Headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Autonomic Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- 13 May 2018 (actual)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 12 May 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.
Monitor the safety and performance of the Pulsante Microstimulator System.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who meet the CE marked labeling for cluster headache for the Pulsante Microstimulator System
Key inclusion criteria (3 listed)
- Patient meets CE marked labeling for cluster headache.
- Patient has the ability to read, comprehend and reliably record information as required by the Protocol.
- Patient is able to provide written informed consent prior to participation in the study.
Key exclusion criteria (1 listed)
- 1. Patient 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
Characterization of all device/procedure related Adverse Events
Time frame: Through five years post implant
Outcome will be assessed at Implant, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant.
1 secondary outcome
Acute response to therapy
Time frame: Through five years post implant
Results and safety
Results are not available in the source record.
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 5 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 9 sites in 5 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 3 inclusion and 1 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: status not confirmed, 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 9 sites in Germany, Denmark, Sweden, Switzerland, United Kingdom. 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?
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?
Characterization of all device/procedure related Adverse Events (time frame: Through five years post implant). 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; AzTrials last refreshed its copy on 27 Oct 2026.