Cluster headache MedDRA version: 20.0 Level: PT Classification code 10059133 Term: Cluster headache System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: LLT Classification code 10009698 Term: Cluster headaches System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Signifor
Product Name: pasireotide (as pasieriotide diaspartate)
Product Code: SOM230 s.c.
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pasireotide
CAS Number: 396091-7
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Subject is male or female age 18-65 inclusive. o Written informed consent must be obtained before any assessment is performed. o 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. o 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. o Subject is able to self-inject medication subcutaneously or have the assistance of a helper on an out-patient basis, if subject is not domiciled in a clinic for the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: o Subjects that have a history of greater than 6 CH attacks per day within the last year. o Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment. Men who are sexually active with women of child bearing potential, unless they use contraception as specified in Section 5.1 during the study.Contraception specific details are listed in Section 5.1. o History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study. o 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. o 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) o Uncontrolled diabetes as evidenced by screening HbA1c > 8.0% o A positive Hepatitis B surface antigen or Hepatitis C test result. o A positive pregnancy test or lactating mothers. o Acute cholecystitis or symptomatic cholelithiasis in subjects without H/O cholecystectomy o History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result. o 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 and in the judgement of the Investigator. o Significant acute illness which has not resolved within two (2) weeks prior to initial dosing. o Any surgical or medical condition which might significantly jeopardize the subject's safety in case of participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess headache response of single subcutaneous s.c. dose of SOM230 compared to placebo in managing cluster headache attack at 30 minutes post-dosing.;Secondary Objective: •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 •To assess the safety and tolerability of SOM230 ;Primary end point(s): Percent (%) of patients with headache response 30 minutes post dose. Defined as very severe, severe, or moderate pain before dosing that becomes mild or nil at 30 minutes post-dosing.;Timepoint(s) of evaluation of this end point: 30 minutes post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percent of patients who are pain free at 30 minutes post dose.;Timepoint(s) of evaluation of this end point: 30 minutes post dose | — |
Countries
Germany, United Kingdom, United States
Contacts
Public ContactMedica Information Services
Novartis Pharmaceuticals UK Limited
Outcome results
None listed