Safety and Efficacy Study of SOM230 s.c. in Cluster Headache (NCT02619617) | Clinical Trial Compass
TerminatedPhase 2
Safety and Efficacy Study of SOM230 s.c. in Cluster Headache
Stopped: Novartis decision based on Cohort 1 results
United States, Germany, United Kingdom28 participantsStarted 2016-10-31
Plain-language summary
The purpose of this study was to determine if SOM230 is safe and effective for the treament of cluster headache.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Subject is male or female age 18-65 inclusive.
* Written informed consent must be obtained before any assessment is performed.
* Subjects must have established diagnosis of episodic cluster headaches (CH) or chronic CH, averaging 2-6 headache attacks per day each lasting at least 45 minutes without treatment, not to exceed 6 attacks per day within the last year.
* Able to communicate well with the investigator, to understand and comply with the requirements of the study, as well as accepting NOT to share any study information through social media during their participation in the study.
* Subject is able to self-inject medication subcutaneously or have the assistance of a partner on an out-patient basis.
Exclusion Criteria:
* Subjects that have a history of greater than 6 CH attacks per day within the last year.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the duration dosing of the study treatment. Or men who are sexually active with women of child bearing potential, unless the male subjects always use condoms during the study.
* History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study.
* Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regul…
What they're measuring
1
Number of Participants With Headache Response (PD Analysis Set)