Cluster Headache - Episodic and ChronicPhase 2NCT02619617
Safety and Efficacy Study of SOM230 s.c. in Cluster Headache
A Phase 2 study testing SOM230 in people with Cluster Headache - Episodic and Chronic, run by Novartis Pharmaceuticals at 4 sites in 3 countries.
Trial summary
The purpose of this study was to determine if SOM230 is safe and effective for the treament of cluster headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cluster Headache - Episodic and Chronic
- What is being tested?
- SOM230
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 31 Oct 2016to 25 Sep 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Novartis Investigative Site
Culver City, California, 90230
Novartis Investigative Site
Philadelphia, Pennsylvania, 19107
About this study
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.)
The purpose of this study was to determine if SOM230 is safe and effective for the treament of cluster headache.
Read the 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.
- Conditions
- Cluster Headache - Episodic and Chronic
- Being tested
- SOM230, Placebo
- Keywords
- Cluster Headache, Patient Diary collection of headache pain
- Medical subject headings
- Cluster Headache, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOM230Drug
The study evaluated SOM230 vs Placebo
PlaceboDrug
The study evaluated SOM230 vs Placebo
| Study group | Role | What they receive |
|---|---|---|
| SOM230 0.9mg | Experimental | cohort 2 Receives: Drug: SOM230; Drug: Placebo |
| SOM230 1.5 mg | Experimental | cohort 1 Receives: Drug: SOM230; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes post dose
Secondary outcomes (3)
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.
Measured: 30 mins post dose
Change in Hemoglobin Values From Screening to End of Study
Change in hemoglobin values from screening and end of study
Measured: screening and end of study, up to 9 days after treatment
Pulse Rate
Vital signs by treatment and time point
Measured: screening and end of study, up to 9 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study start31 Oct 2016
- Primary completion25 Sep 2018
- Study completion25 Sep 2018
Why it stopped: Novartis decision based on Cohort 1 results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cluster Headache - Episodic and ChronicStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619617
- Sponsor's protocol ID
- CSOM230Y2201
- Status last verified
- Dec 2019
- First submitted
- 30 Nov 2015
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.)
- ClinicalTrials.gov ID
- NCT02619617
- Acronym / sponsor ID
- CSOM230Y2201
- Conditions
- Cluster Headache - Episodic and Chronic
- Keywords
- Cluster Headache, Patient Diary collection of headache pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Novartis decision based on Cohort 1 results
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine if SOM230 is safe and effective for the treament of cluster headache.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOM230 0.9mg | Experimental | Drug: SOM230, Drug: Placebocohort 2 |
| SOM230 1.5 mg | Experimental | Drug: SOM230, Drug: Placebocohort 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOM230The study evaluated SOM230 vs Placebo | Drug | SOM230 0.9mg, SOM230 1.5 mg |
| PlaceboThe study evaluated SOM230 vs Placebo | Drug | SOM230 0.9mg, SOM230 1.5 mg |
Primary outcome
Number of Participants With Headache Response (PD Analysis Set)
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
3 secondary outcomes
Number of Participants Who Were Pain Free at 30 Minutes Post Dose
Time frame: 30 mins post dose
Change in Hemoglobin Values From Screening to End of Study
Time frame: screening and end of study, up to 9 days after treatment
Pulse Rate
Time frame: screening and end of study, up to 9 days after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SOM230 in people with Cluster Headache - Episodic and Chronic, run by Novartis Pharmaceuticals at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Headache Response (PD Analysis Set) (time frame: 30 minutes post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.