Safety and Efficacy Study of SOM230 s.c. in Cluster Headache
TerminatedPhase 2NCT02619617
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study was to determine if SOM230 is safe and effective for the treament of cluster headache.
Study details
- 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.)
- Conditions
- Cluster Headache - Episodic and Chronic
- Interventions
- Drug: SOM230
- Drug: Placebo
- Sponsor
- Novartis Pharmaceuticals
- Organization
- Novartis
- Start date
- 2016-10-31
- Primary completion
- 2018-09-25
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Germany, United Kingdom, United States
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 medic…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02619617