MigraineNCT01841827
The Headache Inducing Effects of Cilostazol on Migraine Patients
A study testing Cilostazol in people with Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
We will use Cilostazol as a tool to investigate its headache inducing effects in migraine patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine
- What is being tested?
- Cilostazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to Jun 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with migraine without aura according to the IHS criteria from 2004.
- Healthy besides migraine
Who cannot join
- Tension-type headache more than 3 days per month
- Other types of primary headaches
- Pregnancy
- History of vascular diseases or psychiatric diseases.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center & Department of Neurology
Copenhagen, Glostrup, 2600
About this study
We will use Cilostazol as a tool to investigate its headache inducing effects in migraine patients.
- Conditions
- Migraine
- Being tested
- Cilostazol, 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.
CilostazolDrug
Also called Pletal
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol | Active comparator | Capsule of Cilostazol 200 mg are taken orally on each study day Receives: Drug: Cilostazol |
| Placebo | Placebo comparator | A capsule of placebo containing starch are taken orally on each study day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidens of headache or migraine after adminstration of Cilostazol in migraine patients compared to placebo.
Rectruitment of 14 patients will be done during April and May. Experiments will be carried out in May and June. Each experiment day takes 1½ hour. Data analysis will be done in June and July. Final data will be presented within 6 months.
Measured: Outcome measure will be done within 3 month. Final data will be presented within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Guo, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841827
- Sponsor's protocol ID
- H-2-2013-033
- Status last verified
- Jun 2014
- First submitted
- 20 Apr 2013
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Headache Inducing Effects of Cilostazol on Migraine Patients
- ClinicalTrials.gov ID
- NCT01841827
- Acronym / sponsor ID
- H-2-2013-033
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Apr 2013 (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.
We will use Cilostazol as a tool to investigate its headache inducing effects in migraine patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol | Active comparator | Drug: CilostazolCapsule of Cilostazol 200 mg are taken orally on each study day |
| Placebo | Placebo comparator | Drug: PlaceboA capsule of placebo containing starch are taken orally on each study day. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with migraine without aura according to the IHS criteria from 2004.
- Healthy besides migraine
Key exclusion criteria (4 listed)
- Tension-type headache more than 3 days per month
- Other types of primary headaches
- Pregnancy
- History of vascular diseases or psychiatric diseases.
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 |
|---|---|---|
| CilostazolAlso: Pletal | Drug | Cilostazol |
| Placebo | Drug | Placebo |
Primary outcome
The incidens of headache or migraine after adminstration of Cilostazol in migraine patients compared to placebo.
Time frame: Outcome measure will be done within 3 month. Final data will be presented within 6 months
Rectruitment of 14 patients will be done during April and May. Experiments will be carried out in May and June. Each experiment day takes 1½ hour. Data analysis will be done in June and July. Final data will be presented within 6 months.
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 6 Jun 2014.
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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.
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 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 2 inclusion and 4 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 6 Jun 2014. 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?
The incidens of headache or migraine after adminstration of Cilostazol in migraine patients compared to placebo. (time frame: Outcome measure will be done within 3 month. Final data will be presented within 6 months). 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 6 Jun 2014.