Study Stopped
The study was terminated prematurely due to poor recruitment.
The Effects of Caffeine Withdrawal on Migraine
1 other identifier
interventional
10
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2016
CompletedFirst Posted
Study publicly available on registry
January 18, 2017
CompletedStudy Start
First participant enrolled
February 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2019
CompletedJuly 23, 2019
July 1, 2019
2.4 years
December 29, 2016
July 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Migraine days
Reduction from baseline in monthly migraine days (withdrawal vs. caffeine)
10 weeks
Secondary Outcomes (4)
Withdrawal symptoms and/or syndrome (according to criteria)
2 first days after caffeine withdrawal(withdrawal vs. caffeine)
Migraine attacks
10 weeks
Sleep improvement
10 weeks
Quality of life
10 weeks
Study Arms (2)
Caffeine
ACTIVE COMPARATORCaffeine tablets (Recip) 100 mg, 300-800 mg
Placebo
PLACEBO COMPARATORPlacebo tablets
Interventions
From the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nordlandssykehuset HFlead
- King's College Londoncollaborator
- University Hospital of North Norwaycollaborator
Study Sites (3)
Nordland Hospital
Bodø, 8011, Norway
Departement of Neurology, NLSH HF
Bodø, 8092, Norway
Departement of Neurology
Tromsø, 9037, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jan T Henriksen
Department for research and patient safety, Nordland Hospital trust
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2016
First Posted
January 18, 2017
Study Start
February 28, 2017
Primary Completion
July 22, 2019
Study Completion
July 22, 2019
Last Updated
July 23, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share