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
be a sequential design of SOM230 vs. Placebo.

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