A Study to Explore the Long-Term Safety of TEV-48125 for the Prevention of Cluster Headache

Condition:   Cluster Headache Intervention:   Drug: Fremanezumab Sponsor:   Teva Branded Pharmaceutical Products, R&D Inc. Enrolling by invitation – verified July 2017 Source: ClinicalTrials.gov Listing of Cluster Headache trials This is a 68-week study to evaluate the long-term safety of fremanezumab in patients with CH. Patients who complete the pivotal studies and enroll into the current study will visit the investigational … Read more

Psilocybin for the Treatment of Cluster Headache

The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen in cluster headache. Subjects will be randomized to receive oral placebo, low dose psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days. Subjects will maintain a headache diary prior to, during, and after the pulse regimen in order to document headache frequency and intensity before, during, and after the pulse regimen.

Actigraphy and Nocturnal Heartrate Variability in Cluster Headache Patients

The aim in this project is to study the intercept between the sleep-wake cycle, autonomic tone and the occurrence of headache attacks, by using actigraphy, heart-rate variability and pupillometry. All these methods are well validated, and frequently used in studies on sleep and autonomic function. The study design is that of a case-control model where 15 cluster headache patients will undergo pupillometry, before wearing the actigraph and heart-rate variability-monitor for two weeks, once in cluster bout and once in remission phase.

Safety and Efficacy Study of SOM230 s.c. in Cluster Headache

The purpose of this non-confirmatory study is to determine if SOM230 has adequate efficacy and safety to warrant further clinical development in cluster headache (CH). This study will have two parts. Part A will be a parallel design SOM230 vs. Placebo, and following an observed signal in Part A at an interim analysis, Part B of the study will be a comparison of SOM230 to sumatriptan.