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

NCT ID: NCT02619617

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-09-25

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.

Conditions

Cluster Headache - Episodic and Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SOM230 0.9mg

cohort 2

Group Type: EXPERIMENTAL

SOM230

Intervention Type: DRUG

The study evaluated SOM230 vs Placebo

Placebo

Intervention Type: DRUG

The study evaluated SOM230 vs Placebo

SOM230 1.5 mg

cohort 1

Group Type: EXPERIMENTAL

SOM230

Intervention Type: DRUG

The study evaluated SOM230 vs Placebo

Placebo

Intervention Type: DRUG

The study evaluated SOM230 vs Placebo

Interventions

SOM230

The study evaluated SOM230 vs Placebo

Intervention Type: DRUG

Placebo

The study evaluated SOM230 vs Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Culver City, California, United States

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Novartis Investigative Site

Königstein im Taunus, Taunus, Germany

Novartis Investigative Site

London, , United Kingdom

Countries

United States; Germany; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=313

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

CSOM230Y2201

Identifier Type: -

Identifier Source: org_study_id