Chronic Cluster HeadacheNCT01255813
Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache
A study testing Stimulation (Sub-perception) and Stimulation (Full) in people with Chronic Cluster Headache, run by Autonomic Technologies, Inc. at 5 sites in 4 countries.
Trial summary
The purpose of the proposed clinical study is to evaluate the use of an implanted Neurostimulator to provide Sphenopalatine Ganglion (SPG) stimulation for the management of the pain associated with cluster headaches. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Cluster Headache
- What is being tested?
- Stimulation (Sub-perception) and Stimulation (Full)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Dec 2010to Mar 2013
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years old (inclusive).
- Subject has been diagnosed with chronic cluster headache according to the 2004 International Headache Society (IHS) criteria 3.1.2.
- Subject reports a minimum of 4 cluster headaches per week.
- Subject reports dissatisfaction with current cluster headache treatment (Criterion includes both preventive or abortive therapy per the Investigator's standard of care. Reasons for dissatisfaction with existing headache therapies may include failure of therapies, contraindication, side effects of therapies, or patient refusal of available therapies)
- Subject is able to distinguish cluster headaches from other headaches (i.e., tension-type headaches).
- Subject has the ability to read and 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 or dosage of prophylactic headache medications < one (1) month prior to study enrollment
- Subject has undergone facial surgery in the area of the pterygopalatine fossa or zygomaticomaxillary buttress ipsilateral to the planned implant site within the last four (4) months.
- Subject has active oral or dental abscess.
- Subject has been treated with radiation to the facial region within the last six (6) months.
- Subject has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving the face that have been active or required treatment in the past six (6) months.
- Subject has other significant pain problem that might confound the study assessments in the opinion of the Investigator.
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- Subject is a woman of childbearing age who is pregnant, nursing, or not using contraception.
- Subject is currently participating or has participated in the last month in another clinical study in which the subject has, is, or will be exposed to an investigational or non-investigational drug or device.
- Subject is felt to be at risk of non-compliance (e.g., for completing the diary or maintaining a stable headache medicine regimen) in the Investigator's opinion.
- Subject has had previous lesional radio-frequency ablation of the ipsilateral sphenopalatine ganglion (SPG).
- Subject has had blocks of the ipsilateral SPG in the last three (3) months.
- Subject has undergone botulinum toxin injections of the head and/or neck in the last three (3) months.
- Subject has or requires a pacemaker/defibrillator or other implantable device having a sense amplifier.
- Subject has a history of bleeding disorders or coagulopathy or is unable to discontinue anticoagulation, antiplatelet, or GP IIb IIIa inhibitor medication in preparation for the implantation procedure.
- Subject is not suitable for the study for any reason in the judgment of the Investigator.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Germany2 sites
Headache Center, Dept. of Neurology, University Duisburg-Essen
Essen, 45147
Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246
Denmark1 site
Danish Headache Center, Dept. of Neurology, Glostrup Hospital
Glostrup Municipality, 2600
Spain1 site
Department of Neurology, University Clinic Hospital, University of Valencia
Valencia, 46010
About this study
The purpose of the proposed clinical study is to evaluate the use of an implanted Neurostimulator to provide Sphenopalatine Ganglion (SPG) stimulation for the management of the pain associated with cluster headaches.
- Conditions
- Chronic Cluster Headache
- Being tested
- Stimulation (Sub-perception), Stimulation (Full), Control
- Keywords
- Chronic Cluster Headache
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation (Sub-perception)Device
Stimulation applied below the perception threshold
Stimulation (Full)Device
Stimulation applied above the perception threshold
ControlOther
No stimulation applied
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Control |
| Sub-perception | Experimental | Not described Receives: Device: Stimulation (Sub-perception) |
| Full Stimulation | Experimental | Not described Receives: Device: Stimulation (Full) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of device related Serious Adverse Events (SAEs)
Measured: Implant through the Experimental Period
Acute Pain Relief response (as defined by patient)
Measured: 15 minutes
Secondary outcomes (5)
Pain Freedom
Measured: 15 minutes
Rescue medication use
Use of medications to treat headache pain within 90 minutes after initiating therapy.
Measured: 90 minutes
Pain Relief after initiating therapy
Measured: 30 minutes
Pain Relief after initiating therapy
Measured: 60 minutes
Pain Relief after initiating therapy
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autonomic Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Schoenen, M.D., Principal investigator, Professor of Functional Neuroanatomy, Leige University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255813
- Sponsor's protocol ID
- Pathway CH-1 (CIP-001)
- Status last verified
- Dec 2015
- First submitted
- 3 Dec 2010
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache
- ClinicalTrials.gov ID
- NCT01255813
- Acronym / sponsor ID
- Pathway CH-1 (CIP-001)
- Conditions
- Chronic Cluster Headache
- Keywords
- Chronic Cluster Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Autonomic Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 7 Dec 2010 (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 purpose of the proposed clinical study is to evaluate the use of an implanted Neurostimulator to provide Sphenopalatine Ganglion (SPG) stimulation for the management of the pain associated with cluster headaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Control |
| Sub-perception | Experimental | Device: Stimulation (Sub-perception) |
| Full Stimulation | Experimental | Device: Stimulation (Full) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 18 to 65 years old (inclusive).
- Subject has been diagnosed with chronic cluster headache according to the 2004 International Headache Society (IHS) criteria 3.1.2.
- Subject reports a minimum of 4 cluster headaches per week.
- Subject reports dissatisfaction with current cluster headache treatment (Criterion includes both preventive or abortive therapy per the Investigator's standard of care. Reasons for dissatisfaction with existing headache therapies may include failure of therapies, contraindication, side effects of therapies, or patient refusal of available therapies)
- Subject is able to distinguish cluster headaches from other headaches (i.e., tension-type headaches).
Key exclusion criteria (15 listed)
- Subject has had a change in type or dosage of prophylactic headache medications < one (1) month prior to study enrollment
- Subject has undergone facial surgery in the area of the pterygopalatine fossa or zygomaticomaxillary buttress ipsilateral to the planned implant site within the last four (4) months.
- Subject has active oral or dental abscess.
- Subject has been treated with radiation to the facial region within the last six (6) months.
- Subject has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving the face that have been active or required treatment in the past six (6) months.
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 |
|---|---|---|
| Stimulation (Sub-perception)Stimulation applied below the perception threshold | Device | Sub-perception |
| Stimulation (Full)Stimulation applied above the perception threshold | Device | Full Stimulation |
| ControlNo stimulation applied | Other | Placebo |
Primary outcome
Number of device related Serious Adverse Events (SAEs)
Time frame: Implant through the Experimental Period
Acute Pain Relief response (as defined by patient)
Time frame: 15 minutes
5 secondary outcomes
Pain Freedom
Time frame: 15 minutes
Rescue medication use
Time frame: 90 minutes
Pain Relief after initiating therapy
Time frame: 30 minutes
Pain Relief after initiating therapy
Time frame: 60 minutes
Pain Relief after initiating therapy
Time frame: 90 minutes
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 29 Dec 2015.
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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.
Jean Schoenen, M.D. principal investigator
Professor of Functional Neuroanatomy, Leige University
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation (Sub-perception) and Stimulation (Full) in people with Chronic Cluster Headache, run by Autonomic Technologies, Inc. at 5 sites in 4 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 7 inclusion and 15 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 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Belgium, Denmark, Spain. 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. Some participants in this study may receive a placebo. 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?
Number of device related Serious Adverse Events (SAEs) (time frame: Implant through the Experimental Period). 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 29 Dec 2015.