In 2024, Norwegian Center for Headache Research, NorHead, is conducting 14 ongoing clinical trials involving more than 2300 patients with various headache disorders. Additionally, six new clinical trials will commence during 2024 or early 2025, involving nearly 900 additional patients. Among this year's highlights is the CandMig study, in which candesartan 8 mg and 16 mg are being tested against a placebo in 450 patients at 10 centers in Norway and one center in Estonia. The results will be presented in a dedicated session at the European Headache Conference in December.
Furthermore, we have published "open-label" data from 261 injections of botulinum toxin targeting the sphenopalatine ganglion (SPG) using neuronavigation, showing efficacy in treatment-resistant chronic migraine and chronic cluster headache. In another study, over two hundred patients with migraine with aura from three European countries contributed data that form the basis for a new international classification of visual disturbances in migraine (aura). These results will also be presented at the European Headache Conference.
The StatinMig studies, which examine the use of atorvastatin as a preventive treatment for episodic and chronic migraine, began in September 2024 and will include 750 patients from across the country. We have also completed a procurement process for the NorHead database, which will be finalized by March 2025, and will collect data through national headache diaries in collaboration with patients. The use of national health registries is also a key research area for NorHead. For example, in August 2024, we published a survey on the use of acute and preventive medications across the entire Norwegian population from 2010 to 2020. The survey showed a slight increase in the use of preventive treatments, but that usage remains significantly lower than the estimated need.
After extensive efforts, we have also received approval to link the major socioeconomic and health registers in Norway, providing even greater opportunities to analyze the consequences of headache disorders across the population. We also have several projects related to artificial intelligence in the field of headache disorders. One of this year's highlights is the results from a project presented at the Migraine Trust International Symposium in London in September 2024. In this project, we presented machine learning algorithms that outperformed existing methods for measuring the effects of genetic material on disease variables.
In addition to our extensive research activities, NorHead has given several presentations at international conferences, taught at national meetings for general practitioners, and is organizing the National Headache Conference in Trondheim in November. We participated in several events at Arendalsuka and co-organized the conference on User Involvement in Research, which was held in Bergen. We are also co-organizers of the National Patient Conference for Headache.
Headaches disorders are among the most common and disabling diseases worldwide. Yet, they are poorly understood and under-emphasized in government policies, with few novel therapeutic options being advanced. At present, there are few initiatives at an international scale aimed at improving patients' situations. The 2018 National Brain Health Strategy identified headaches as a topic with large unmet needs. Thus far, little has been done. We have identified three main research areas, directly addressed by the secondary objectives, that together serve the overall objective and ambition of NorHEAD.
Within the first research area, we will conduct clinical trials leading to evidence-based new and improved treatment options for headache disorders. We will perform an ambitious large-scale pragmatic study with an aim to construct a decision-support system for choosing effective migraine treatment. The trial will be complemented by a meticulous collection of paraclinical biomarkers to facilitate neurobiological understanding and treatment optimization. Moreover, we will establish new treatments for the neglected pediatric migraine population, develop a new eHealth intervention for medication overuse headache, investigate and establish non-pharmacological interventions including biofeedback and structured lifestyle interventions, develop and establish new botulinum toxin treatment paradigms for chronic migraine and tension-type headache, and establish new surgical options for chronic cluster headache and refractory trigeminal neuralgia.
Within the second research area, we will exploit the rich health register databases in Norway, using unique epidemiological approaches to identify demographic and genetic markers of etiology and responsiveness, repurpose drugs and evaluate societal impact.
Finally, we will exploit machine learning to develop prescriptive models, enlighten disease etiology and treatment mechanisms, and enable clinical individualized decision-support tools.