Trial Outcomes & Findings for Safety and Efficacy Study of SOM230 s.c. in Cluster Headache (NCT NCT02619617)
NCT ID: NCT02619617
Last Updated: 2021-01-05
Results Overview
Defined as very severe, severe, or moderate pain before dosing that becomes mild or nil at 30 minutes post-dosing
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
30 minutes post dose
Results posted on
2021-01-05
Participant Flow
This study was planned to have 2 cohorts using a one-sequence two-period design to compare SOM230 vs. placebo. Two consecutive CH attacks were treated: the first attack was treated with placebo (Period 1) and the subsequent attack was treated with SOM230 (Period 2). However, Cohort 2 was not initiated.
Participant milestones
| Measure |
Placebo s.c.
Single dose of placebo
|
SOM230 1.5 mg s.c.
Single dose of SOM230 1.5 mg s.c.
|
|---|---|---|
|
Period 1 Placebo - 1st AttacK
STARTED
|
28
|
0
|
|
Period 1 Placebo - 1st AttacK
Participants Included in PD Analysis
|
20
|
0
|
|
Period 1 Placebo - 1st AttacK
Participants in Safety Set for Period 1
|
28
|
0
|
|
Period 1 Placebo - 1st AttacK
COMPLETED
|
28
|
0
|
|
Period 1 Placebo - 1st AttacK
NOT COMPLETED
|
0
|
0
|
|
Period 2 SOM230 - 2nd Attack
STARTED
|
0
|
28
|
|
Period 2 SOM230 - 2nd Attack
Participants in Safety Set for Period 2
|
0
|
28
|
|
Period 2 SOM230 - 2nd Attack
COMPLETED
|
0
|
24
|
|
Period 2 SOM230 - 2nd Attack
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Placebo s.c.
Single dose of placebo
|
SOM230 1.5 mg s.c.
Single dose of SOM230 1.5 mg s.c.
|
|---|---|---|
|
Period 2 SOM230 - 2nd Attack
Protocol Violation
|
0
|
1
|
|
Period 2 SOM230 - 2nd Attack
Physician Decision
|
0
|
3
|
Baseline Characteristics
Safety and Efficacy Study of SOM230 s.c. in Cluster Headache
Baseline characteristics by cohort
| Measure |
Placebo s.c. /1.5 mg SOM230 s.c.
n=28 Participants
A: single dose of placebo s.c. (Period 1) B: single dose of 1.5 mg s.c. SOM230 (Period 2)
|
|---|---|
|
Age, Continuous
|
43.9 Years
STANDARD_DEVIATION 10.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes post dosePopulation: PD analysis set: Subjects with protocol deviations which impacted PD data were excluded from the PD analysis
Defined as very severe, severe, or moderate pain before dosing that becomes mild or nil at 30 minutes post-dosing
Outcome measures
| Measure |
Placebo s.c.
n=20 Participants
A single dose of placebo s.c.
|
SOM230 1.5 mg
n=20 Participants
A single dose of 1.5 mg s.c. SOM230
|
|---|---|---|
|
Number of Participants With Headache Response (PD Analysis Set)
|
9 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 30 mins post dosePopulation: PD analysis set)
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.
Outcome measures
| Measure |
Placebo s.c.
n=20 Participants
A single dose of placebo s.c.
|
SOM230 1.5 mg
n=20 Participants
A single dose of 1.5 mg s.c. SOM230
|
|---|---|---|
|
Number of Participants Who Were Pain Free at 30 Minutes Post Dose
|
5 participants
|
7 participants
|
SECONDARY outcome
Timeframe: screening and end of study, up to 9 days after treatmentPopulation: Safety analysis set
Change in hemoglobin values from screening and end of study
Outcome measures
| Measure |
Placebo s.c.
n=28 Participants
A single dose of placebo s.c.
|
SOM230 1.5 mg
A single dose of 1.5 mg s.c. SOM230
|
|---|---|---|
|
Change in Hemoglobin Values From Screening to End of Study
Screening
|
153.4 g/L
Standard Deviation 12.93
|
—
|
|
Change in Hemoglobin Values From Screening to End of Study
End of Study
|
149.5 g/L
Standard Deviation 15.13
|
—
|
SECONDARY outcome
Timeframe: screening and end of study, up to 9 days after treatmentPopulation: Safety analysis set
Vital signs by treatment and time point
Outcome measures
| Measure |
Placebo s.c.
n=28 Participants
A single dose of placebo s.c.
|
SOM230 1.5 mg
A single dose of 1.5 mg s.c. SOM230
|
|---|---|---|
|
Pulse Rate
Screening
|
77.2 Beats/min
Standard Deviation 15.02
|
—
|
|
Pulse Rate
Baseline
|
78.1 Beats/min
Standard Deviation 11.99
|
—
|
|
Pulse Rate
Period 1 - Placebo
|
76.9 Beats/min
Standard Deviation 12.77
|
—
|
|
Pulse Rate
Period 2 - SOM230 1.5 mg
|
74.0 Beats/min
Standard Deviation 10.86
|
—
|
|
Pulse Rate
End of Study
|
81.1 Beats/min
Standard Deviation 13.50
|
—
|
Adverse Events
1.5 mg SOM230 s.c.
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo s.c.
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1.5 mg SOM230 s.c.
n=26 participants at risk
single dose of 1.5 mg s.c. SOM230
|
Placebo s.c.
n=28 participants at risk
A single dose of placebo s.c.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.5%
3/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.9%
7/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Gastrointestinal disorders
Flatulence
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Gastrointestinal disorders
Nausea
|
46.2%
12/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Gastrointestinal disorders
Vomiting
|
26.9%
7/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
3.6%
1/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
General disorders
Fatigue
|
23.1%
6/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
3.6%
1/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
General disorders
Injection site bruising
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
3.6%
1/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
General disorders
Injection site erythema
|
15.4%
4/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
3.6%
1/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
General disorders
Injection site pain
|
19.2%
5/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
3.6%
1/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
General disorders
Injection site reaction
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
3.6%
1/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
General disorders
Injection site warmth
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
General disorders
Malaise
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
3.6%
1/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Investigations
Haematocrit decreased
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Investigations
Red blood cell count decreased
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
0.00%
0/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
|
Vascular disorders
Flushing
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
3.6%
1/28 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 26 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER