The Effects of Caffeine Withdrawal on Migraine

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03022838
• Other study ID #: 2015/1729REK
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: February 28, 2017
• Est. completion date: July 22, 2019

Study information

• Verified date: July 2019
• Source: Nordlandssykehuset HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 22, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Caffeine Withdrawal
• Migraine
• Migraine Disorders

Intervention

Drug:
• Caffeine
From the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg).

Locations

Country	Name	City	State
Norway	Departement of Neurology, NLSH HF	Bodø
Norway	Nordland Hospital	Bodø
Norway	Departement of Neurology	Tromsø

Sponsors (3)

Lead Sponsor	Collaborator
Nordlandssykehuset HF	King's College London, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine days	Reduction from baseline in monthly migraine days (withdrawal vs. caffeine)	10 weeks
Secondary	Withdrawal symptoms and/or syndrome (according to criteria)	If patients report withdrawal symptoms, these will be recorded and eventually diagnosed as either caffeine withdrawal symptoms or migraineous symptoms in accordance with international criteria	2 first days after caffeine withdrawal(withdrawal vs. caffeine)
Secondary	Migraine attacks	Reduction from baseline in monthly migraine attacks (withdrawal vs. caffeine)	10 weeks
Secondary	Sleep improvement	Reduction from baseline in PSQI and measured by actigraphy (withdrawal vs. caffeine)	10 weeks
Secondary	Quality of life	Reduction from baseline in HIT-6 (withdrawal vs. caffeine)	10 weeks