The purpose of this study was to determine if SOM230 is safe and effective for the treament of cluster headache.
The purpose of this non-confirmatory study was to determine if SOM230 has adequate efficacy and safety to warrant further clinical development in cluster headache (CH). This study was a sequential design of SOM230 vs. Placebo.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Novartis Investigative Site
Culver City, California, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Königstein im Taunus, Taunus, Germany
Novartis Investigative Site
London, United Kingdom
Number of Participants With Headache Response (PD Analysis Set)
Defined as very severe, severe, or moderate pain before dosing that becomes mild or nil at 30 minutes post-dosing
Time frame: 30 minutes post dose
Number of Participants Who Were Pain Free at 30 Minutes Post Dose
Participants who were pain free 30 minutes after dosing and reporting improvement of associated autonomic symptoms (for example, lacrimation, blushing, pupil constriction, etc.) over time was tabulated by dose.
Time frame: 30 mins post dose
Change in Hemoglobin Values From Screening to End of Study
Change in hemoglobin values from screening and end of study
Time frame: screening and end of study, up to 9 days after treatment
Pulse Rate
Vital signs by treatment and time point
Time frame: screening and end of study, up to 9 days after treatment
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