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

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.)

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

Study Overview

• Status: Terminated
• Conditions: Cluster Headache - Episodic and Chronic
• Intervention / Treatment: Drug: SOM230; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Taunus
    • Königstein im Taunus, Taunus, Germany, 61462
      • Novartis Investigative Site
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Novartis Investigative Site
• United States
  • California
    • Culver City, California, United States, 90230
      • Novartis Investigative Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOM230 0.9mg; cohort 2	Drug: SOM230; The study evaluated SOM230 vs Placebo; Drug: Placebo; The study evaluated SOM230 vs Placebo
Experimental: SOM230 1.5 mg; cohort 1	Drug: SOM230; The study evaluated SOM230 vs Placebo; Drug: Placebo; The study evaluated SOM230 vs Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2016
• Primary Completion (Actual): September 25, 2018
• Study Completion (Actual): September 25, 2018

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Cluster Headache; Patient Diary collection of headache pain
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pasireotide
• Other Study ID Numbers: CSOM230Y2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com