Trial · NCT02619617
Safety and Efficacy Study of SOM230 s.c. in Cluster Headache
NCT02619617, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2020-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of SOM230 s.c. in Cluster Headache. Trials, record NCT02619617. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02619617
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of SOM230 s.c. in Cluster Headache
- NCT number
- NCT02619617
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Cluster Headache - Episodic and Chronic
- Interventions
- SOM230, Placebo
- First posted
- 2015-12-02
- Last updated
- 2021-01-05
- Results first posted
- 2020-01-13
- Limitations and caveats
- Terminated (Non-efficacy in first Phase 2a cohort.)
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Headache Response (PD Analysis Set) | 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 | Number of Participants Who Were Pain Free at 30 Minutes Post Dose | 30 mins 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. |
| Secondary | Change in Hemoglobin Values From Screening to End of Study | screening and end of study, up to 9 days after treatment | Change in hemoglobin values from screening and end of study |
| Secondary | Pulse Rate | screening and end of study, up to 9 days after treatment | Vital signs by treatment and time point |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Headache Response (PD Analysis Set) | 30 minutes post dose | PD analysis set: Subjects with protocol deviations which impacted PD data were excluded from the PD analysis | participants | NUMBER |
| SECONDARY | Number of Participants Who Were Pain Free at 30 Minutes Post Dose | 30 mins post dose | PD analysis set) | participants | NUMBER |
| SECONDARY | Change in Hemoglobin Values From Screening to End of Study | screening and end of study, up to 9 days after treatment | Safety analysis set | g/L | MEAN |
| SECONDARY | Pulse Rate | screening and end of study, up to 9 days after treatment | Safety analysis set | Beats/min | MEAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Headache Response (PD Analysis Set) | Placebo s.c. | 9 | participants | ||
| Number of Participants With Headache Response (PD Analysis Set) | SOM230 1.5 mg | 10 | participants | ||
| Number of Participants Who Were Pain Free at 30 Minutes Post Dose | Placebo s.c. | 5 | participants | ||
| Number of Participants Who Were Pain Free at 30 Minutes Post Dose | SOM230 1.5 mg | 7 | participants | ||
| Change in Hemoglobin Values From Screening to End of Study | Placebo s.c. /1.5 mg SOM230 s.c. | Screening | 153.4 | Standard Deviation 12.93 | g/L |
| Change in Hemoglobin Values From Screening to End of Study | Placebo s.c. /1.5 mg SOM230 s.c. | End of Study | 149.5 | Standard Deviation 15.13 | g/L |
| Pulse Rate | Placebo s.c. /1.5 mg SOM230 s.c. | Screening | 77.2 | Standard Deviation 15.02 | Beats/min |
| Pulse Rate | Placebo s.c. /1.5 mg SOM230 s.c. | Baseline | 78.1 | Standard Deviation 11.99 | Beats/min |
| Pulse Rate | Placebo s.c. /1.5 mg SOM230 s.c. | Period 1 - Placebo | 76.9 | Standard Deviation 12.77 | Beats/min |
| Pulse Rate | Placebo s.c. /1.5 mg SOM230 s.c. | Period 2 - SOM230 1.5 mg | 74.0 | Standard Deviation 10.86 | Beats/min |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 Placebo - 1st AttacK | STARTED | Placebo s.c. | 28 | |
| Period 1 Placebo - 1st AttacK | STARTED | SOM230 1.5 mg s.c. | 0 | |
| Period 1 Placebo - 1st AttacK | Participants Included in PD Analysis | Placebo s.c. | 20 | |
| Period 1 Placebo - 1st AttacK | Participants Included in PD Analysis | SOM230 1.5 mg s.c. | 0 | |
| Period 1 Placebo - 1st AttacK | Participants in Safety Set for Period 1 | Placebo s.c. | 28 | |
| Period 1 Placebo - 1st AttacK | Participants in Safety Set for Period 1 | SOM230 1.5 mg s.c. | 0 | |
| Period 1 Placebo - 1st AttacK | COMPLETED | Placebo s.c. | 28 | |
| Period 1 Placebo - 1st AttacK | COMPLETED | SOM230 1.5 mg s.c. | 0 | |
| Period 1 Placebo - 1st AttacK | NOT COMPLETED | Placebo s.c. | 0 | |
| Period 1 Placebo - 1st AttacK | NOT COMPLETED | SOM230 1.5 mg s.c. | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | 1.5 mg SOM230 s.c. | 1 | 26 | |
| other | Palpitations | Cardiac disorders | Placebo s.c. | 0 | 28 | |
| other | Abdominal distension | Gastrointestinal disorders | 1.5 mg SOM230 s.c. | 1 | 26 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo s.c. | 0 | 28 | |
| other | Abdominal pain | Gastrointestinal disorders | 1.5 mg SOM230 s.c. | 3 | 26 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo s.c. | 0 | 28 | |
| other | Diarrhoea | Gastrointestinal disorders | 1.5 mg SOM230 s.c. | 7 | 26 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo s.c. | 0 | 28 | |
| other | Flatulence | Gastrointestinal disorders | 1.5 mg SOM230 s.c. | 1 | 26 | |
| other | Flatulence | Gastrointestinal disorders | Placebo s.c. | 0 | 28 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1.5 mg SOM230 s.c. | 0 | 26 |
| Total, all-cause mortality | Placebo s.c. | 0 | 28 |
| Total, other adverse events | 1.5 mg SOM230 s.c. | 23 | 26 |
| Total, other adverse events | Placebo s.c. | 5 | 28 |
| Total, serious adverse events | 1.5 mg SOM230 s.c. | 0 | 26 |
| Total, serious adverse events | Placebo s.c. | 0 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SOM230 1.5 mg vs Placebo s.c.: Number of Participants Who Were Pain Free at 30 Minutes Post Dose | Trial comparisons |
| SOM230 1.5 mg vs Placebo s.c.: Number of Participants With Headache Response (PD Analysis Set) | Trial comparisons |
| 1.5 mg SOM230 s.c. vs Placebo s.c.: deaths from any cause | Trial comparisons |
| 1.5 mg SOM230 s.c. vs Placebo s.c.: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02619617
GET https://conductscience.org/api/trials/v1/NCT02619617/events?page=2