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The Effects of Caffeine Withdrawal on Migraine

Primary Purpose

Migraine, Caffeine Withdrawal

Status
Terminated
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Caffeine
Sponsored by
Nordlandssykehuset HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nordland Hospital
  • Departement of Neurology, NLSH HF
  • Departement of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Caffeine

Placebo

Arm Description

Caffeine tablets (Recip) 100 mg, 300-800 mg

Placebo tablets

Outcomes

Primary Outcome Measures

Migraine days
Reduction from baseline in monthly migraine days (withdrawal vs. caffeine)

Secondary Outcome Measures

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
Migraine attacks
Reduction from baseline in monthly migraine attacks (withdrawal vs. caffeine)
Sleep improvement
Reduction from baseline in PSQI and measured by actigraphy (withdrawal vs. caffeine)
Quality of life
Reduction from baseline in HIT-6 (withdrawal vs. caffeine)

Full Information

First Posted
December 29, 2016
Last Updated
July 22, 2019
Sponsor
Nordlandssykehuset HF
Collaborators
King's College London, University Hospital of North Norway
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1. Study Identification

Unique Protocol Identification Number
NCT03022838
Brief Title
The Effects of Caffeine Withdrawal on Migraine
Official Title
The Effects of Caffeine Withdrawal on Migraine - a Randomized, Double-blind, Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated prematurely due to poor recruitment.
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
July 22, 2019 (Actual)
Study Completion Date
July 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordlandssykehuset HF
Collaborators
King's College London, University Hospital of North Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Caffeine Withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caffeine
Arm Type
Active Comparator
Arm Description
Caffeine tablets (Recip) 100 mg, 300-800 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets
Intervention Type
Drug
Intervention Name(s)
Caffeine
Other Intervention Name(s)
Recip
Intervention Description
From the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg).
Primary Outcome Measure Information:
Title
Migraine days
Description
Reduction from baseline in monthly migraine days (withdrawal vs. caffeine)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Withdrawal symptoms and/or syndrome (according to criteria)
Description
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
Time Frame
2 first days after caffeine withdrawal(withdrawal vs. caffeine)
Title
Migraine attacks
Description
Reduction from baseline in monthly migraine attacks (withdrawal vs. caffeine)
Time Frame
10 weeks
Title
Sleep improvement
Description
Reduction from baseline in PSQI and measured by actigraphy (withdrawal vs. caffeine)
Time Frame
10 weeks
Title
Quality of life
Description
Reduction from baseline in HIT-6 (withdrawal vs. caffeine)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan T Henriksen
Organizational Affiliation
Department for research and patient safety, Nordland Hospital trust
Official's Role
Study Director
Facility Information:
Facility Name
Nordland Hospital
City
Bodø
ZIP/Postal Code
8011
Country
Norway
Facility Name
Departement of Neurology, NLSH HF
City
Bodø
ZIP/Postal Code
8092
Country
Norway
Facility Name
Departement of Neurology
City
Tromsø
ZIP/Postal Code
9037
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Caffeine Withdrawal on Migraine

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