An interventional study of Cilostazol 200mg and SUMAtriptan 6 MG/ML in Migraine, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by Danish Headache Center · Not applicable, Interventional, and Treatment
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Among 42 studies testing sumatriptan in Migraine Disorders — none open to participants now, none under way, none of them phase 3. Sumatriptan · Migraine Disorders.
Among the 42 studies testing sumatriptan in Migraine Disorders, this one is the 30th largest by enrollment, is one of 3 that started in 2017, is one of 8 with no phase, and was the 38th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →None of the 42 studies testing sumatriptan in Migraine Disorders is open now. The open studies under Migraine Disorders, anywhere →
Sumatriptan: first FDA approval 1992 (IMITREX STATDOSE (AUTOINJECTOR)). What it is approved for, and how studies give it, is on its page →
Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
42 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Median enrollment 74 across the 42 interventional studies. Of the 40 that completed or were terminated, 20 (50%) have results posted.
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27 of 42 have an industry lead sponsor. The 10 most frequent:
Danish Headache Center is the lead sponsor of 129 studies on the registry; 15 are open to participants now.
57 studies in Migraine Disorders by Danish Headache Center: 9 open now, 10 under way, none of them phase 3. Of 40 finished, 0 (0%) have results posted.
Among the 57 studies in Migraine Disorders by Danish Headache Center, this one is the 15th largest by enrollment of the 48 interventional ones that give a count, is one of 4 that started in 2017, is one of 42 with no phase, and was the 24th registered.
Danish Headache Center’s Migraine Disorders studies by the year they started, since 2003.
None of the studies under way reaches primary completion within a year.
Among the 42 studies testing sumatriptan in Migraine Disorders, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Danish Headache Center’s 57 in Migraine Disorders:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
headache is induced with Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan
Drug: Cilostazol 200mg · Drug: SUMAtriptan 6 MG/ML
headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb
Drug: Cilostazol 200mg · Drug: Placebo
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Also known as: Pletal
Drug page: Sumatriptan
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Also known as: Imigran
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Difference in median headache score after sumatriptan/placebo
The investigators will assess the outcome measures 1 year after the beginning of the study
Time frame: 2hours
difference in AUC 0-4h post treatment
The difference in area under the curve 0-4h after treatment with sumatriptan and placebo
Time frame: 4hours
Plan to share: No
Ran from Nov 2017 to primary completion in Sep 2018, 10 months.
Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 10 months is below that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sumatriptan