Cluster HeadacheNCT01958125
A Randomized Multicentre Study for the Acute Relief of Episodic and Chronic Cluster Headache.
A study testing gammaCore in people with Cluster Headache, run by ElectroCore INC at 9 sites in 4 countries.
Trial summary
The study will look at a non-invasive treatment for people suffering with chronic and episodic headaches. Study subjects will be randomized to an active treatment or an in-active treatment for 2 weeks. After the 2 weeks all subjects will continue to treat with an active treatment for an additional 2 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cluster Headache
- What is being tested?
- gammaCore
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Aug 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Is 18 years or older
- Has been diagnosed with episodic or chronic cluster headache in accordance with the ICHD-2 Classification criteria (2ndEd)
- Is capable of completing the 5-point pain scale, disability scale and other self-assessments
- Agrees to refrain from starting new medication aimed to control the cluster headache for the duration of the run-in and randomized phase
- Is able to provide written Informed Consent
Who cannot join
- Episodic cluster headache sufferers who are not in a cluster headache bout at the time of screening and enrollment
- 2. Need to commence treatment with oral or injectable steroids for eventual concomitant medical conditions
- 3. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore® treatment site
- 4. Is currently taking medication for indications other than CH that in the opinion of the clinician may interfere with the study
- 5. Has a history of any cranial aneurysm, intracranial haemorrhage, brain tumours or significant head trauma
- 6. Diagnosed or suspected secondary headache
Show all 20Show fewer
- 7. Has other significant pain problem that might confound the study assessments in the opinion of the investigator
- 8. Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of transient ischemic attack (TIA) or cerebral vascular accident CVA), congestive heart failure (CHF), known severe coronary artery disease or recent (5 years) myocardial infarction
- 9. Has an abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction)
- 10. Has had a previous, cervical vagotomy
- 11. Has uncontrolled high blood pressure
- 12. Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
- 13. Has a history of carotid endarterectomy or vascular neck surgery
- 14. Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site
- 15. Has a recent (12 months) or repeated history of syncope
- 16. Has a recent (12 months) or repeated history of seizure
- 17. Has a known history or suspicion of substance abuse or addiction, or overuse of acute headache medication
- 18. Has psychiatric or cognitive disorder and/or behavioural problems which in the opinion of the clinician may interfere with the study
- 19. Is pregnant, nursing, thinking of becoming pregnant in the next 6 weeks 20. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days
- 21. Is a relative of or an employee of the investigator or the clinical study site
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United Kingdom4 sites
The Southern Hospital, Neurology Department
Glasgow, Lanarkshire, G51 4TF
Hull Royal Infirmary, Neurology Department
Hull, East Yorkshire, HU3 2JZ
The Walton Center, Neurology Department
Liverpool, Merseyside, L9 7LJ
Royal Free, Dept for Neurology and Clinical Neurosciences
London, Greater London, NW3 2QG
Germany3 sites
Westdeutches Kopfschmerzzentrum
Essen, D-45147
Kopfschmerzklinik Königstein
Königstein im Taunus, D-61462
Klinikum Grosshadern, University of Munich
Munich, D-81377
Denmark1 site
Glostrup Hospital, Danish Headache Centre
Glostrup Municipality, DK-2600
Netherlands1 site
Leiden University Medical Center, Neurology Department, K5-Q-104
Leiden, 2333 ZA
About this study
Official title: A Randomized, Multicentre, Double-blind, Parallel, Sham-controlled Study of GammaCore®, a Non-invasive Neurostimulator Device for the Acute Relief of Episodic and Chronic Cluster Headache.
The study will look at a non-invasive treatment for people suffering with chronic and episodic headaches. Study subjects will be randomized to an active treatment or an in-active treatment for 2 weeks. After the 2 weeks all subjects will continue to treat with an active treatment for an additional 2 weeks.
Read the detailed description
The study is a prospective double blind, randomized, sham-controlled, multi-center investigation designed for comparison of two parallel groups, GammaCore® (active treatment) and a sham, (in-active) treatment. The study period begins with a 1-week run-in period, followed by a 2 week comparative period when the subjects are randomized (1:1) to either active treatment or sham (in-active) treatment. The comparative period will be followed by an open label 2 week period, where the subjects in the sham treatment group will switch in treatment assignment and receive an active treatment and the active group will continue to receive an active treatment.
- Conditions
- Cluster Headache
- Being tested
- gammaCore
- Keywords
- vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, cluster headache, non invasive, gammacore
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gammaCoreDevice
Vagal stimulation
| Study group | Role | What they receive |
|---|---|---|
| gammacore | Active comparator | gammacore active device to be used noninvasively to the vagal nerve in the neck. Receives: Device: gammaCore |
| inactive gammacore | Placebo comparator | same as the active treatment, but without the therapy treatment provided Receives: Device: gammaCore |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Headache Pain Free Attack Rates at 15 Minutes Following the Treatment
Headache pain was collected at the beginning of the attack (all treated attacks) and 15 minutes post treatment pain free attacks.
Data was collected in the patient diary.
Measured: 2 weeks
Secondary outcomes (4)
Change in Disability From Baseline (Randomization) to 2 Weeks After Baseline
Mean difference of scores on a 5 step disability scale. Disability was measured at baseline and after the randomization phase (2 weeks later). Lowest score is 1 and is better than the higher score at 5 that is the worst. An increase, higher scores, means worsening.
- minor
- minor/moderate
- moderate
- moderate/severe
- severe
Measured: 2 weeks
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
EQ-5D-3L descriptive system comprises 5 dimensions: mobility, self-care, activity, pain and anxiety. Each dimension has 3 levels: 1 = no problems, 2 = moderate problems, 3=extreme problems. Subjects indicate health state by ticking choosing appropriate statement in each dimension and a VAS scale (Overall health) from 0-100 mm where higher score is better (100) than lower score (0).
Patients completed the EQ-5D-3L at baseline (the start of the randomized period and at 2 weeks).
Measured: 2 weeks
Patients Who Used Any Type of Rescue Medication
Following treatment at 15 minutes, patients recorded use of any rescue medication(s) in the diary'
Measured: 2 weeks
Comparison of the Headache Pain Free Attack Rates at 30 Minutes Following the Treatment
The headache pain was collected at the beginning of the attack and 30 minutes post treatment in the patient diary.
The number of pain free (no pain) attacks are compared to all attacks treated
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElectroCore INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter J. Goadsbury, Prof., Principal investigator, Royal Free Hospital, Dept for Neurology and Clinical Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958125
- Sponsor's protocol ID
- GC-003
- Status last verified
- Feb 2019
- First submitted
- 4 Oct 2013
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: The study is publlished and no other IPD data will be shared.
Publications
de Coo IF, Marin JC, Silberstein SD, Friedman DI, Gaul C, McClure CK, Tyagi A, Liebler E, Tepper SJ, Ferrari MD, Goadsby PJ. Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis. Cephalalgia. 2019 Jul;39(8):967-977. doi: 10.1177/0333102419856607. Epub 2019 Jun 10.
PubMed 31246132
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicentre, Double-blind, Parallel, Sham-controlled Study of GammaCore®, a Non-invasive Neurostimulator Device for the Acute Relief of Episodic and Chronic Cluster Headache.
- ClinicalTrials.gov ID
- NCT01958125
- Acronym / sponsor ID
- GC-003
- Conditions
- Cluster Headache
- Keywords
- vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, cluster headache, non invasive, gammacore
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- ElectroCore INCIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 26 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will look at a non-invasive treatment for people suffering with chronic and episodic headaches. Study subjects will be randomized to an active treatment or an in-active treatment for 2 weeks. After the 2 weeks all subjects will continue to treat with an active treatment for an additional 2 weeks.
Detailed description
The study is a prospective double blind, randomized, sham-controlled, multi-center investigation designed for comparison of two parallel groups, GammaCore® (active treatment) and a sham, (in-active) treatment. The study period begins with a 1-week run-in period, followed by a 2 week comparative period when the subjects are randomized (1:1) to either active treatment or sham (in-active) treatment. The comparative period will be followed by an open label 2 week period, where the subjects in the sham treatment group will switch in treatment assignment and receive an active treatment and the active group will continue to receive an active treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gammacore | Active comparator | Device: gammaCoregammacore active device to be used noninvasively to the vagal nerve in the neck. |
| inactive gammacore | Placebo comparator | Device: gammaCoresame as the active treatment, but without the therapy treatment provided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is 18 years or older
- Has been diagnosed with episodic or chronic cluster headache in accordance with the ICHD-2 Classification criteria (2ndEd)
- Is capable of completing the 5-point pain scale, disability scale and other self-assessments
- Agrees to refrain from starting new medication aimed to control the cluster headache for the duration of the run-in and randomized phase
- Is able to provide written Informed Consent
Key exclusion criteria (20 listed)
- Episodic cluster headache sufferers who are not in a cluster headache bout at the time of screening and enrollment
- 2. Need to commence treatment with oral or injectable steroids for eventual concomitant medical conditions
- 3. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore® treatment site
- 4. Is currently taking medication for indications other than CH that in the opinion of the clinician may interfere with the study
- 5. Has a history of any cranial aneurysm, intracranial haemorrhage, brain tumours or significant head trauma
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 |
|---|---|---|
| gammaCoreVagal stimulation | Device | gammacore, inactive gammacore |
Primary outcome
Comparison of the Headache Pain Free Attack Rates at 15 Minutes Following the Treatment
Time frame: 2 weeks
Headache pain was collected at the beginning of the attack (all treated attacks) and 15 minutes post treatment pain free attacks. Data was collected in the patient diary.
4 secondary outcomes
Change in Disability From Baseline (Randomization) to 2 Weeks After Baseline
Time frame: 2 weeks
Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
Time frame: 2 weeks
Patients Who Used Any Type of Rescue Medication
Time frame: 2 weeks
Comparison of the Headache Pain Free Attack Rates at 30 Minutes Following the Treatment
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31246132de Coo IF, Marin JC, Silberstein SD, Friedman DI, Gaul C, McClure CK, Tyagi A, Liebler E, Tepper SJ, Ferrari MD, Goadsby PJ. Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis. Cephalalgia. 2019 Jul;39(8):967-977. doi: 10.1177/0333102419856607. Epub 2019 Jun 10.
- Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A randomized, double-blind, sham-controlled ACT2 study.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The study is publlished and no other IPD data will be shared.
Related trials for Cluster Headache
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Not yet recruitingPhase 2
Zavegepant Intranasal Spray for the Acute Treatment of Episodic Cluster Headache
Cluster Headache
Active, not recruiting
Yogabased Movements for Primary Headaches (Migraine and/or Cluster Headache) - YOURHEAD - a Pilot Study
Cluster Headache - Episodic and Chronic, Migraine Headache
Recruiting
Yogabased Movements for Primary Headaches (Migraine and/or Cluster Headache) - YOURHEAD
Cluster Headache - Episodic and Chronic, Migraine Headache
RecruitingObservational study
Italian Trigeminal Autonomic Cephalalgias Assessment Study
Trigeminal Autonomic Cephalalgias, Cluster Headache
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.
Peter J. Goadsbury, Prof. principal investigator
Royal Free Hospital, Dept for Neurology and Clinical Neurosciences
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gammaCore in people with Cluster Headache, run by ElectroCore INC at 9 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 5 inclusion and 20 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 Feb 2019. 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 United Kingdom, Germany, Denmark, Netherlands. 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?
Yes. Results are posted in the registry (first posted 26 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of the Headache Pain Free Attack Rates at 15 Minutes Following the Treatment (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01958125, which also lists 1 linked publication.
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 Feb 2019.