MigrainePhase 2/3NCT03022838
The Effects of Caffeine Withdrawal on Migraine
A Phase 2/3 study testing Caffeine in people with Migraine and Caffeine Withdrawal, run by Nordlandssykehuset HF at 3 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Caffeine Withdrawal
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 3 sitesNorway
- Study dates
- 28 Feb 2017to 22 Jul 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Nordland Hospital
Bodø, 8011
Departement of Neurology, NLSH HF
Bodø, 8092
Departement of Neurology
Tromsø, 9037
About this study
Official title: The Effects of Caffeine Withdrawal on Migraine - a Randomized, Double-blind, Crossover Study
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.
Read the 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. .
- Conditions
- Migraine, Caffeine Withdrawal
- Being tested
- Caffeine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Also called Recip
From the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg).
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Active comparator | Caffeine tablets (Recip) 100 mg, 300-800 mg Receives: Drug: Caffeine |
| Placebo | Placebo comparator | Placebo tablets Receives: Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine days
Reduction from baseline in monthly migraine days (withdrawal vs. caffeine)
Measured: 10 weeks
Secondary outcomes (4)
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
Measured: 2 first days after caffeine withdrawal(withdrawal vs. caffeine)
Migraine attacks
Reduction from baseline in monthly migraine attacks (withdrawal vs. caffeine)
Measured: 10 weeks
Sleep improvement
Reduction from baseline in PSQI and measured by actigraphy (withdrawal vs. caffeine)
Measured: 10 weeks
Quality of life
Reduction from baseline in HIT-6 (withdrawal vs. caffeine)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start28 Feb 2017
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Why it stopped: The study was terminated prematurely due to poor recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, University Hospital of North Norway
- Responsible party
- Sponsor
- Investigators
- Jan T Henriksen, Study director, Department for research and patient safety, Nordland Hospital trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022838
- Sponsor's protocol ID
- 2015/1729REK
- Status last verified
- Jul 2019
- First submitted
- 29 Dec 2016
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Caffeine Withdrawal on Migraine - a Randomized, Double-blind, Crossover Study
- ClinicalTrials.gov ID
- NCT03022838
- Acronym / sponsor ID
- 2015/1729REK
- Conditions
- Migraine, Caffeine Withdrawal
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely due to poor recruitment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Collaborators
- King's College London, University Hospital of North Norway
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Active comparator | Drug: CaffeineCaffeine tablets (Recip) 100 mg, 300-800 mg |
| Placebo | Placebo comparator | Drug: CaffeinePlacebo tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaffeineAlso: RecipFrom the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg). | Drug | Caffeine, Placebo |
Primary outcome
Migraine days
Time frame: 10 weeks
Reduction from baseline in monthly migraine days (withdrawal vs. caffeine)
4 secondary outcomes
Withdrawal symptoms and/or syndrome (according to criteria)
Time frame: 2 first days after caffeine withdrawal(withdrawal vs. caffeine)
Migraine attacks
Time frame: 10 weeks
Sleep improvement
Time frame: 10 weeks
Quality of life
Time frame: 10 weeks
Results and safety
The study was stopped early (reason given: The study was terminated prematurely due to poor recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan T Henriksen study director
Department for research and patient safety, Nordland Hospital trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Caffeine in people with Migraine and Caffeine Withdrawal, run by Nordlandssykehuset HF at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated prematurely due to poor recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine days (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.