Acute MigraineAmiciNCT02185703
Chordate System S020 Acute Migraine Clinical Investigation
A study testing Chordate System S020 in treatment mode in people with Acute Migraine, run by Chordate Medical at 9 sites in Germany.
Trial summary
The main purpose of the study is to evaluate the impact of treatment with the Chordate System S020 (medical device) on acute migraine headache pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Migraine
- What is being tested?
- Chordate System S020 in treatment mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 9 sitesGermany
- Study dates
- Jul 2014to Jul 2015
- 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
- Subjects with migraine, with or without aura according to International Headache Society (IHS) classification (International Classification of Headache Disorders [ICHD]-III beta).
- History of 1 to 6 migraine attacks per month for at least 12 previous months.
- At least 50% of previous migraine attacks had moderate or severe pain intensity.
- History of at least 48 hours of freedom from headache between migraine attacks.
- The majority of the previous untreated migraine attacks lasted at least 8 hours.
- Migraine onset before the age of 50 years.
Who cannot join
- History (within one year prior to inclusion into this clinical investigation) of 15 or more headache days per month (i.e. headaches of any kind).
- More than 6 days per month with non-migraine headaches (within one year prior to inclusion into this clinical investigation).
- Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack.
- Treatment with Botox in the head/neck area within 6 months of the screening visit, or between the screening and treatment visit.
- Previously treated with an implantable stimulator or any implantable devices in the head and/or neck.
- Pronounced anterior septal nasal deviation.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Charité - Universitätsmedizin Berlin / Campus Mitte Klinik für Neurologie
Berlin, State of Berlin, 10117
Praxis für Neurologie und Psychiatrie, Psychotherapie, Schmerztherapie
Erding, Bavaria, 85435
Universitätsklinikum Essen / Neurologische Klinik
Essen, North Rhine-Westphalia, 45122
Universitätsklinikum Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Migräne-Klinik Königstein
Königstein im Taunus, Hesse, 61462
Neurologie- & Kopfschmerzzentrum
München, Bavaria, 80802
Klinikum Großhadern / Neurologische Klinik der Universität München
München, Bavaria, 81377
Universitätsklinikum Tübingen / Zentrum für Neurologie
Tübingen, Baden-Wurttemberg, 72076
Praxis für spezielle Schmerztherapie
Wegberg, North Rhine-Westphalia, 41844
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Performance and Safety of the Chordate System When Used in the Treatment of Acute Migraine Attacks of Moderate to Severe Intensity
The main purpose of the study is to evaluate the impact of treatment with the Chordate System S020 (medical device) on acute migraine headache pain.
Read the detailed description
One single migraine attack will be treated either with the Chordate System S020 or with Chordate System in placebo mode.
After a screening visit, up to 3 months before treatment, eligible subjects will be asked to return to the center at the onset of their next moderate to severe migraine attack. Subjects will be re-checked for eligibility, randomized and treated at the center (treatment visit). The subjects will record their response over the next 48 hours using a diary card. A follow-up visit will be scheduled 3 to 7 days after the treatment. In addition the subjects will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to discuss their health including new or ongoing AEs.
- Conditions
- Acute Migraine
- Being tested
- Chordate System S020 in treatment mode, Chordate System S020 in placebo mode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chordate System S020 in treatment modeDevice
Chordate System S020 in placebo modeDevice
| Study group | Role | What they receive |
|---|---|---|
| Chordate System S020 in treatment mode | Experimental | Not described Receives: Device: Chordate System S020 in treatment mode |
| Chordate System S020 in placebo mode | Sham comparator | Not described Receives: Device: Chordate System S020 in placebo mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache relief
Percentage of subjects with a decrease in migraine headache pain from severe or moderate prior treatment to mild or none at 2 hours after treatment initiation with no use of rescue medication during this time period.
Measured: 2 hours after treatment initiation
Secondary outcomes (9)
Pain-free rate
Percentage of subjects pain-free (pain intensity rated 'No pain') at 2 hours after treatment initiation with no use of rescue medication.
Measured: 2 hours after treatment initiation
Incidence of recurrence
Measured: 48 hours after treatment initiation
24 hour sustained pain-free rate
percentage of subjects remaining pain-free
Measured: 24 hours after treatment initiation
48 hour sustained pain-free rate
percentage of subjects remaining pain-free
Measured: 48 hours after treatment initiation
Time to meaningful relief
Measured: 4 hours post-treatment initiation
Change in nausea, photophobia, phonophobia, vomiting and disability
Measured: 2 hours post-treatment initiation
Subject global impression
Measured: 48 hours post-treatment initiation.
Use of rescue medication
Measured: 48 hours post-treatment initiation
Frequency, severity, device-relationship and outcome of all adverse events
Measured: 48 hours post-treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Too slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute MigraineStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chordate Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans-Christoph Diener, Prof. Dr., Principal investigator, Universitätsklinikum Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185703
- Sponsor's protocol ID
- PM004
- Acronym
- Amici
- Status last verified
- Aug 2015
- First submitted
- 4 Jul 2014
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Performance and Safety of the Chordate System When Used in the Treatment of Acute Migraine Attacks of Moderate to Severe Intensity
- ClinicalTrials.gov ID
- NCT02185703
- Acronym / sponsor ID
- Amici / PM004
- Conditions
- Acute Migraine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too slow recruitment rate
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Chordate MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 9 Jul 2014 (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 main purpose of the study is to evaluate the impact of treatment with the Chordate System S020 (medical device) on acute migraine headache pain.
Detailed description
One single migraine attack will be treated either with the Chordate System S020 or with Chordate System in placebo mode.
After a screening visit, up to 3 months before treatment, eligible subjects will be asked to return to the center at the onset of their next moderate to severe migraine attack. Subjects will be re-checked for eligibility, randomized and treated at the center (treatment visit). The subjects will record their response over the next 48 hours using a diary card. A follow-up visit will be scheduled 3 to 7 days after the treatment. In addition the subjects will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to discuss their health including new or ongoing AEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chordate System S020 in treatment mode | Experimental | Device: Chordate System S020 in treatment mode |
| Chordate System S020 in placebo mode | Sham comparator | Device: Chordate System S020 in placebo mode |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with migraine, with or without aura according to International Headache Society (IHS) classification (International Classification of Headache Disorders [ICHD]-III beta).
- History of 1 to 6 migraine attacks per month for at least 12 previous months.
- At least 50% of previous migraine attacks had moderate or severe pain intensity.
- History of at least 48 hours of freedom from headache between migraine attacks.
- The majority of the previous untreated migraine attacks lasted at least 8 hours.
Key exclusion criteria (6 listed)
- History (within one year prior to inclusion into this clinical investigation) of 15 or more headache days per month (i.e. headaches of any kind).
- More than 6 days per month with non-migraine headaches (within one year prior to inclusion into this clinical investigation).
- Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack.
- Treatment with Botox in the head/neck area within 6 months of the screening visit, or between the screening and treatment visit.
- Previously treated with an implantable stimulator or any implantable devices in the head and/or neck.
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 |
|---|---|---|
| Chordate System S020 in treatment mode | Device | Chordate System S020 in treatment mode |
| Chordate System S020 in placebo mode | Device | Chordate System S020 in placebo mode |
Primary outcome
Headache relief
Time frame: 2 hours after treatment initiation
Percentage of subjects with a decrease in migraine headache pain from severe or moderate prior treatment to mild or none at 2 hours after treatment initiation with no use of rescue medication during this time period.
9 secondary outcomes
Pain-free rate
Time frame: 2 hours after treatment initiation
Incidence of recurrence
Time frame: 48 hours after treatment initiation
24 hour sustained pain-free rate
Time frame: 24 hours after treatment initiation
48 hour sustained pain-free rate
Time frame: 48 hours after treatment initiation
Time to meaningful relief
Time frame: 4 hours post-treatment initiation
Change in nausea, photophobia, phonophobia, vomiting and disability
Time frame: 2 hours post-treatment initiation
Subject global impression
Time frame: 48 hours post-treatment initiation.
Use of rescue medication
Time frame: 48 hours post-treatment initiation
Frequency, severity, device-relationship and outcome of all adverse events
Time frame: 48 hours post-treatment initiation
Results and safety
The study was stopped early (reason given: Too slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 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.
Hans-Christoph Diener, Prof. Dr. principal investigator
Universitätsklinikum Essen
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chordate System S020 in treatment mode in people with Acute Migraine, run by Chordate Medical at 9 sites in Germany.
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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Aug 2015. 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. 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 was stopped early (reason given: Too slow recruitment rate). 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?
Headache relief (time frame: 2 hours after treatment initiation). 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 5 Aug 2015.