Identifying coincident drugs that alter headache progression and remission.

Study type
Protocol
Date of Approval
Study reference ID
17_255
Lay Summary

Migraine is a debilitating headache disorder, ranked by the World Health Organization as one of the leading causes of disability worldwide. Headache disorders are one of the commonest reasons a person will see a GP. Most patients seeing their GP for headache will have migraine and there is a significant unmet medical need for migraine treatments. Currently, migraine can be treated with acute analgesics, including NSAIDs (non-steroidal anti-inflammatory drug), triptans or with migraine preventatives, such as topiramate. However, many migraine sufferers are prone to develop intolerable side effects or in some cases, the migraine does not respond to treatment. In this study, we will describe patterns of prescribed headache treatment use, the potential for headache relapse after a treatment and we will examine records of drugs, not used in migraine treatment and that have been prescribed to assess whether this treatment is associated with the resolution of headaches.

Technical Summary

We will examine drugs, not used in the treatment of migraine, that have been prescribed for another indication to assess whether this treatment is associated with remission or relapse of headache by undergoing a cohort and two nested case-control studies. The cohort longitudinal study will be used to describe the use of prescription analgesic and migraine preventative treatment patterns over time and confirm the efficacy of migraine preventatives in headache remission.
Estimates in efficacy of headache remission will be calculated over commonly prescribed drugs, not used in migraine treatment and prescribed to the patient for another indication. We will use Cox proportional hazards regression where the outcomes will be time to remission and time to relapse before moving onto multivariate Cox regression with time dependent covariates to explore potential nonlinear time trends.
Nested case-control studies will be used to explore the association between headache remission, persistence and relapse with prescription of drugs not used in migraine. Conditional logistic regression will be used to calculate odds ratio of a headache moving into remission or a patient moving into relapse. Critical variables will be controlled for and confounding factors will be taken into account in both cohort and case-control analysis.

Health Outcomes to be Measured

Headache/ migraine resolution (Primary)
- Prescription analgesic use persistence (Primary)
- Number of neurology referrals (Secondary)
- Cessation of all migraine preventative use. (Secondary)
- Number of emergency admissions (Secondary)
- GP consultation rate (Secondary)

Collaborators

Zameel Cader - Chief Investigator - University of Oxford
Zameel Cader - Corresponding Applicant - University of Oxford
Alejo Nevado-Holgado - Collaborator - University of Oxford
Alice Fuller - Collaborator - University of Oxford
Anthony Nash - Collaborator - University of Oxford
Caleb Webber - Collaborator - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of Oxford
Simon Lovestone - Collaborator - University of Oxford

Linkages

Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation