Clinical Trials/NCT02619617

NCT02619617

Terminated

Phase 2

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.)

Novartis Pharmaceuticals1 site in 1 country28 target enrollmentOctober 31, 2016

ConditionsCluster Headache - Episodic and Chronic

InterventionsSOM230 Placebo

DrugsSOM230 Placebo

Overview

Phase: Phase 2
Intervention: SOM230
Conditions: Cluster Headache - Episodic and Chronic
Sponsor: Novartis Pharmaceuticals
Enrollment: 28
Locations: 1
Primary Endpoint: Number of Participants With Headache Response (PD Analysis Set)
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

October 31, 2016

End Date

September 25, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

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.

Arms & Interventions

SOM230 0.9mg

cohort 2

Intervention: SOM230

SOM230 0.9mg

cohort 2

Intervention: Placebo

SOM230 1.5 mg

cohort 1

Intervention: SOM230

SOM230 1.5 mg

cohort 1

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Participants With Headache Response (PD Analysis Set)

Time Frame: 30 minutes post dose

Defined as very severe, severe, or moderate pain before dosing that becomes mild or nil at 30 minutes post-dosing

Secondary Outcomes

Number of Participants Who Were Pain Free at 30 Minutes Post Dose(30 mins post dose)
Change in Hemoglobin Values From Screening to End of Study(screening and end of study, up to 9 days after treatment)
Pulse Rate(screening and end of study, up to 9 days after treatment)