Safety and Efficacy Study of SOM230 s.c. in Cluster Headache
Condition: Cluster Headache - Episodic and Chronic
MeSH terms: Cluster Headache; Headache
Intervention: SOM230; Placebo
Intervention description: The study evaluated SOM230 vs Placebo; The study evaluated SOM230 vs Placebo
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cluster Headache; Patient Diary collection of headache pain

Summary:

      The purpose of this study was to determine if SOM230 is safe and effective for the treament
      of cluster headache.
    

Eligibility criteria:

        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
             regulations.

          -  A history of clinically significant heart diseases, ECG abnormalities, continued use
             of drugs known to prolong QTc during the study conduct, or any of the following ECG
             abnormalities at screening or baseline:

               -  QTcF > 450 msec (males)

               -  QTcF > 460 msec (females)

          -  Uncontrolled diabetes as evidenced by screening HbA1c > 8.0%

          -  A positive Hepatitis B surface antigen or Hepatitis C test result.

          -  A positive pregnancy test or lactating mothers.

          -  History of drug or alcohol abuse within the 12 months prior to dosing other than
             prescription medications to manage their CH attacks, or evidence of such abuse as
             indicated by the laboratory assays conducted during screening.

          -  Significant acute illness which has not resolved within two (2) weeks prior to initial
             dosing.

          -  Any surgical or medical condition which might significantly jeopardize the subject's
             safety in case of participation in the study. The Investigator should make this
             determination in consideration of the subject's medical history and/or clinical or
             laboratory evidence of any of the following:

          -  Liver disease or liver injury as indicated by abnormal liver function tests. ALT
             (SGPT), AST (SGOT), γ-GT, alkaline phosphatase and serum bilirubin will be tested.

          -  ALT must be within the normal range

          -  Serum bilirubin must not exceed 1.2 x ULN

          -  γ-GT, AST and alkaline phosphatase must not exceed 2 x ULN [If necessary, laboratory
             testing may be repeated on one occasion (as soon as possible) prior to treatment, to
             rule out any laboratory error]

          -  Acute cholecystitis or symptomatic cholelithiasis in subjects without H/O
             cholecystectomy