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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02619617
First received: November 30, 2015
Last updated: September 6, 2017
Last verified: August 2017
  Purpose
The purpose of this study to determine if SOM230 is safe and effective for the treament of cluster headache.

Condition Intervention Phase
Cluster Headache - Episodic and Chronic Drug: SOM230 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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.)

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Percent (%) of patients with headache response [ 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 Outcome Measures:
  • Percent of patients who are pain free at 30 minutes post dose [ Time Frame: 30 mins post dose ]
    To assess pain free response of single s.c. dose of SOM230 compared to placebo in managing cluster headache attack at 30 minutes post-dosing


Estimated Enrollment: 60
Actual Study Start Date: October 31, 2016
Estimated Study Completion Date: January 1, 2019
Estimated Primary Completion Date: January 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOM230 0.9mg
cohort 2
Drug: SOM230
The study will evaluate SOM230 vs Placebo
Drug: Placebo
The study will evaluate SOM230 vs Placebo
Experimental: SOM230 1.5 mg
cohort 1
Drug: SOM230
The study will evaluate SOM230 vs Placebo
Drug: Placebo
The study will evaluate SOM230 vs Placebo

Detailed Description:
The purpose of this non-confirmatory study is to determine if SOM230 has adequate efficacy and safety to warrant further clinical development in cluster headache (CH). This study will be a sequential design of SOM230 vs. Placebo.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02619617

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

Locations
United States, California
Novartis Investigative Site Recruiting
Culver City, California, United States, 90230
United States, Pennsylvania
Novartis Investigative Site Recruiting
Philadelphia, Pennsylvania, United States, 19107
Germany
Novartis Investigative Site Recruiting
Königstein im Taunus, Taunus, Germany, 61462
Novartis Investigative Site Recruiting
Berlin, Germany, 10117
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Hamburg, Germany, 20246
Novartis Investigative Site Recruiting
Munchen, Germany, 81377
United Kingdom
Novartis Investigative Site Recruiting
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02619617     History of Changes
Other Study ID Numbers: CSOM230Y2201
Study First Received: November 30, 2015
Last Updated: September 6, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cluster Headache
Patient Diary collection of headache pain

Additional relevant MeSH terms:
Headache
Cluster Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 19, 2017