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

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

Detailed Description
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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.

Official Title
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A Multicenter, Placebo-Controlled, Single Dose Study in Acute Episodic and Chronic Cluster Headache to Evaluate the Safety and Efficacy of SOM230 Subcutaneous (s.c.)

Conditions
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Cluster Headache - Episodic and Chronic

Intervention / Treatment
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* Drug: SOM230
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOM230 0.9mg<br>cohort 2 | Drug: SOM230<br>* The study evaluated SOM230 vs Placebo<br>Drug: Placebo<br>* The study evaluated SOM230 vs Placebo<br>|
| Experimental: SOM230 1.5 mg<br>cohort 1 | Drug: SOM230<br>* The study evaluated SOM230 vs Placebo<br>Drug: Placebo<br>* The study evaluated SOM230 vs Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 minutes post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 mins post dose | 
| Change in Hemoglobin Values From Screening to End of Study | Change in hemoglobin values from screening and end of study | screening and end of study, up to 9 days after treatment | 
| Pulse Rate | Vital signs by treatment and time point | screening and end of study, up to 9 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cluster Headache, Patient Diary collection of headache pain