Primary Objective:The primary objective is to compare the pain free rates at 15 minutes following the use of GammaCore® with that of a sham device, for acute treatment of cluster headache attacks.Secondary Objectives:The secondary objectives will…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
The primary endpoint is pain free rates at 15 minutes comparing active and
sham.
Secondary outcome
Secondary endpoints:
- Change in mean attack duration for each treatment group from the run-in
period (baseline) to visit 3 (randomized period)
- The reduction in mean disability, will compare the run-in period (baseline)
to visit 3 (randomized period) of the two treatment groups
- Reduction in mean attack severity from the run-in period (baseline) to visit
3 (randomized period)
- Pain free rates at 30 minutes
- Outcome for QOL questionnaires at V3 and at V4 compared with V2
- Dayslost from work at V3 and at V4 compared with V2
- Acute rescue treatments or medications at 15 minutes from start of use of
the study device between active and sham group.
- Subject satisfaction between active and sham group
- Number of adverse events between active and sham group
Background summary
Cluster headache is a seriously debilitating disorder estimated to affect about
0,1 % of the Western European and North American populations. Characterized by
excruciating unilateral pain in rapid and frequent succession, cluster
headaches present such severe symptoms among those afflicted that patients
routinely report they have not has a more painful experience. Sufferers
typically experience between 1 and 3 hours lasting from 15 minutes and up to 3
hours and are classified separately to migraine in the International
Classification of Headache Disorders-second edition. In contrast to migraine,
cluster headache is about 3 times more common in males. Currently, the
underlying cause of cluster headache is not fully understood, but it is thought
that abnormalities of the hypothalamic region are crucial1. Standard of care
treatment include both abortive and prophylactic medications; both with limited
efficacy4. During the onset of headache, many people respond to inhalation of
100% oxygen7.Triptans, nasally as well as subcutaneously, have both been shown
to be effective on acute cluster headache attacks, although there remains an
important and pressing need for new treatments of the acute attack of cluster
headache.
The social and economic burden of cluster headache is significant. Patients
with chronic and active episodic cluster headaches are severely impaired in
non-economic and economic domains such as disability, working life and
psychiatric complaints. Symptoms suggestive of psychiatric co-morbidity:
depressive symptoms (56%), signs of agoraphobia (33%) and suicidal tendencies
(25%) are frequently reported. A study by D*Amico et. al. found that 36% of
cluster headache patients have lost their job and half of the patients had
reduced work time by at least 50%.
Considering the inadequacy of current pharmacologic therapy and considerable
economic and social burden of this debilitating disorder, further research is
warranted on alternative prophylactic and acute treatment options.
The vagus nerve serves an important function in mediating pain signals to the
sensory cortex. Vagus nerve stimulation (VNS) is a procedure that has been used
for the treatment of epilepsy and medication resistant depression and recently
has shown a decreased incidence and severity of cluster headache symptoms.
There is a considerable unmet need for a novel, patient controlled, and
non-invasive way to prevent /treat cluster headache symptoms. Such a treatment
has the potential to not only improve patient quality of life, but also to
reduce lost workdays and reduce healthcare expenditure for the large number of
people who suffer from cluster headache.
Study objective
Primary Objective:
The primary objective is to compare the pain free rates at 15 minutes following
the use of GammaCore® with that of a sham device, for acute treatment of
cluster headache attacks.
Secondary Objectives:
The secondary objectives will compare each treatment group and are:
1. Reduction of disability: 5 step disability scale (1=minor, 2=minor/moderate,
3=moderate,4=moderate/severe and 5=severe)
2. Reduction of mean attack severity
3. Quality of Life: EQ-5D-3L
4. Quality of Life: Headache Impact Test (HIT-6)
5. Need for rescue therapy in addition to study treatment
6. Onset, severity, duration and frequency of adverse events (anticipated and
unanticipated), including determination of device-relatedness
7. Number of SoC rescue treatments or medications needed at 15 and 30 minutes
post stimulation
8. Pain free rates at 30 minutes
Study design
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, (inactive) treatment. The study
period will begin with a one-week run-in period, followed by a two week
comparative period when the subjects will be randomized (1:1) to either active
treatment or sham (inactive) treatment. The comparative period will be followed
by an open label two 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.
Intervention
Once subjects have completed the run-in period, they are randomized to continue
in a two-week comparative period. During this period, the control group will
treat with the sham (inactive) device and the active group will be provided
with a GammaCore® device for acute treatment of their attacks. Subjects will
self-administer treatment, ipsilateral to the attacks, by three 90-120-second
stimulations consecutively administered at the onset of pain or symptoms.
Study burden and risks
There are no significant risks identified with the participation in this study
however study subjects can experience transient symptoms such as:
- Shortness of breath (dyspnea), hoarseness or change in voice during treatment.
- Light-headedness, dizziness, chest pain, fainting (possibly associated with
transient hypotension, bradycardia or decreased MAP)
- Transient pain and muscle twisting during treatment
- Tingling, pricking or a feeling of *pins and needles* on the skin where the
device is applied (paraesthesia or dysaesthesia) lasting beyond the treatment
period
- Minor skin irritation from conductive gel
- Fainting (Syncope) during treatment
- Continued or increased progression of cluster headache symptoms
- Bradycardia
- Tachycardia
- Change in mean arterial pressure (MAP)
electroCore, Skårs Led 3
Göteborg SE-412 63
SE
electroCore, Skårs Led 3
Göteborg SE-412 63
SE
Listed location countries
Age
Inclusion criteria
Inclusion Criteria
1. Is 18 years or older
2. Has been diagnosed with episodic or chronic cluster headache in accordance with the ICHD-2 Classification criteria (2ndEd)
3. Is capable of completing the 5-point pain scale, disability scale and other self-assessment questionnaires.
4. Agrees to refrain from starting new medication aimed to control the cluster headache for the duration of the run-in and randomized phase
5. Is able to provide written Informed Consent
Exclusion criteria
Exclusion Criteria
Subjects meeting any of the following criteria can not be included in this research study
1. 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 cluster headache 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
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 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 seizures
17. Has a known or suspected history 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 during the study period
20. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial within a 30 days period prior to this study
21. Is a relative of or an employee of the investigator or the clinical study site
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01958125 |
| CCMO | NL45248.058.13 |