MigraineNCT03422796
The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache
A study testing Cilostazol 200mg and SUMAtriptan 6 MG/ML in people with Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
To develop a pragmatic migraine model the investigators will induce headache in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan injection, the model can be used to test new drug candidates. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Cilostazol 200mg and SUMAtriptan 6 MG/ML
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2017to 1 Sep 2018
- 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
- Migraine patients who meet IHS criteria for migraine with or without aura of both sexes
- 18-70 years
- 45-95 kg.
Who cannot join
- Any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week)
- Serious somatic or psychiatric disease
- Pregnancy
- Intake of daily medication (except oral contraceptives)
- Triptan non-responders
Trial locations and contacts
1 site in 1 country.
About this study
To develop a pragmatic migraine model the investigators will induce headache in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan injection, the model can be used to test new drug candidates.
Read the detailed description
There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan.
Hypothesis: Cilostazol induces a migraine-like headache in MO-patients and the induced headache responds to sumatriptan injection Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.
- Conditions
- Migraine
- Being tested
- Cilostazol 200mg, SUMAtriptan 6 MG/ML, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol 200mgDrug
Also called Pletal
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
SUMAtriptan 6 MG/MLDrug
Also called Imigran
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
PlaceboDrug
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
| Study group | Role | What they receive |
|---|---|---|
| Sumatriptan | Active comparator | headache is induced with Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan Receives: Drug: Cilostazol 200mg; Drug: SUMAtriptan 6 MG/ML |
| Placebo | Placebo comparator | headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb Receives: Drug: Cilostazol 200mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in median headache score after sumatriptan/placebo
The investigators will assess the outcome measures 1 year after the beginning of the study
Measured: 2hours
difference in AUC 0-4h post treatment
The difference in area under the curve 0-4h after treatment with sumatriptan and placebo
Measured: 4hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start1 Nov 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrine Falkenberg, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422796
- Sponsor's protocol ID
- H-17026731
- Status last verified
- Jan 2020
- First submitted
- 20 Oct 2017
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Falkenberg K, Bjerg HR, Olesen J. Subcutaneous sumatriptan reduces cilostazol induced headache in migraine patients. Cephalalgia. 2020 Jul;40(8):842-850. doi: 10.1177/0333102420915166. Epub 2020 Mar 26.
PubMed 32216457
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache
- ClinicalTrials.gov ID
- NCT03422796
- Acronym / sponsor ID
- H-17026731
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 6 Feb 2018 (actual)
- 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.
To develop a pragmatic migraine model the investigators will induce headache in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan injection, the model can be used to test new drug candidates.
Detailed description
There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan.
Hypothesis: Cilostazol induces a migraine-like headache in MO-patients and the induced headache responds to sumatriptan injection Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sumatriptan | Active comparator | Drug: Cilostazol 200mg, Drug: SUMAtriptan 6 MG/MLheadache is induced with Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan |
| Placebo | Placebo comparator | Drug: Cilostazol 200mg, Drug: Placeboheadache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Migraine patients who meet IHS criteria for migraine with or without aura of both sexes
- 18-70 years
- 45-95 kg.
Key exclusion criteria (5 listed)
- Any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week)
- Serious somatic or psychiatric disease
- Pregnancy
- Intake of daily medication (except oral contraceptives)
- Triptan non-responders
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 |
|---|---|---|
| Cilostazol 200mgAlso: PletalCilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan | Drug | Placebo, Sumatriptan |
| SUMAtriptan 6 MG/MLAlso: ImigranCilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan | Drug | Sumatriptan |
| PlaceboCilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan | Drug | Placebo |
Primary outcome
Difference in median headache score after sumatriptan/placebo
Time frame: 2hours
The investigators will assess the outcome measures 1 year after the beginning of the study
difference in AUC 0-4h post treatment
Time frame: 4hours
The difference in area under the curve 0-4h after treatment with sumatriptan and placebo
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 Jan 2020.
- Derived from this study: PubMed 32216457Falkenberg K, Bjerg HR, Olesen J. Subcutaneous sumatriptan reduces cilostazol induced headache in migraine patients. Cephalalgia. 2020 Jul;40(8):842-850. doi: 10.1177/0333102420915166. Epub 2020 Mar 26.
- Individual participant dataSharing planned: No
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cilostazol 200mg and SUMAtriptan 6 MG/ML in people with Migraine, run by Danish Headache Center at 1 site in Denmark.
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 5 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 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Difference in median headache score after sumatriptan/placebo (time frame: 2hours). 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?
On the ClinicalTrials.gov record for NCT03422796, 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 29 Jan 2020.