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

NCT02619617 | Terminated Phase 2 Results

• 1 other identifier: CSOM230Y2201
• Study Type: interventional
• Target: 28
• Locations: 3 countries
• Sites: 4

Brief Summary

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

Conditions

Cluster Headache - Episodic and Chronic

Keywords

Cluster Headache; Patient Diary collection of headache pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

SOM230 0.9mg

EXPERIMENTAL

cohort 2

Drug: SOM230; Drug: Placebo

SOM230 1.5 mg

EXPERIMENTAL

cohort 1

Drug: SOM230; Drug: Placebo

Interventions

SOM230 DRUG

The study evaluated SOM230 vs Placebo

SOM230 0.9mg; SOM230 1.5 mg

Placebo DRUG

The study evaluated SOM230 vs Placebo

SOM230 0.9mg; SOM230 1.5 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Novartis Investigative Site

Culver City, California, 90230, United States

Location

Novartis Investigative Site

Philadelphia, Pennsylvania, 19107, United States

Location

Novartis Investigative Site

Königstein im Taunus, Taunus, 61462, Germany

Location

Novartis Investigative Site

London, SE5 9RS, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Cluster Headache; Bronchiolitis Obliterans Syndrome

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Limitations and Caveats

Terminated (Non-efficacy in first Phase 2a cohort.)

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 2, 2015
• Study Start: October 31, 2016
• Primary Completion: September 25, 2018
• Study Completion: September 25, 2018
• Last Updated: January 5, 2021
• Results First Posted: January 13, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share

Locations

US (2); DE (1); GB (1)