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The Effects of Caffeine Withdrawal on Migraine - a Randomized, Double-blind, Crossover Study (NCT03022838)

King's College London
Sporadic and chronic dietary consumption of caffeine has substantial biological effects on the nervous system. The effects on migraine are at large not known. In this study we want to assess the effects of caffeine withdrawal on migraine.
  • Drug: Caffeine
    From the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg).
    • Recip
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • migraine present for at least 1 year and fulfilling diagnostic criteria (ICHD-3 beta)
  • =/> 3 migraine attacks per month
  • no migraine prophylaxis the last month
  • consumption =/> 300 mg and </= 800 mg caffeine per day the last month
  • signed consent
Exclusion Criteria:
  • suspicion of medication-overuse headache
  • pregnancy and breast feeding
  • serious co-morbidity or conditions requiring Medical treatment or caution
  • working night shift
  • use of drugs with moderate or major interactions with caffeine
The actions of caffeine as an antagonist of adenosine receptors have been extensively studied, and there is no doubt that both daily and sporadic dietary consumption of caffeine has substantial biological effects on the nervous system. The current opinion is that caffeine both can cure and trigger headaches. Caffeine is a component of many combination drugs marketed for the relief of headaches, but on the other hand it is strongly incriminated as a risk factor for developing chronic headache. Withdrawal may cause symptom constellations similar to the migraine syndrome. Further, caffeine consumption may affect sleep and alertness, possibly influencing the risk of migraine attacks. .

2 locations

Norway (2)
  • Nordland Hospital
    not yet recruiting
    Bodø, Norway, 8011
  • Departement of Neurology, NLSH HF
    recruiting
    Bodø, Norway, 8092
Status:
recruiting
Type:
Interventional
Phase:
Ⅱ, Ⅲ
Start:
27 February, 2017
Updated:
27 February, 2017
Participants:
80
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