Trial Outcomes & Findings for Sphenopalatine Ganglion Blocks RCT (NCT NCT03666663)
NCT ID: NCT03666663
Last Updated: 2021-10-11
Results Overview
Reduction in headache days from baseline to month 8 of treatment as self- reported by the patients (yes/no) and as per headache diary and retrospective charts review documentation
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
8 months
Results posted on
2021-10-11
Participant Flow
Participant milestones
| Measure |
Lidocaine
Participants will receive SPG blocks with lidocaine.
Lidocaine: Nasal application using the Sphenocath device- cleared by FDA
|
Bupivacaine
Participants will receive SPG blocks with bupivacaine
Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA
|
Ropivacaine
Participants will receive SPG blocks with ropivacaine
Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA
|
Placebo (Saline)
Participants will receive SPG blocks with placebo (saline)
Placebo: Placebo Saline using the Sphenocath device- cleared by FDA
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lidocaine
n=3 Participants
Participants will receive SPG blocks with lidocaine.
Lidocaine: Nasal application using the Sphenocath device- cleared by FDA
|
Bupivacaine
n=1 Participants
Participants will receive SPG blocks with bupivacaine
Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA
|
Ropivacaine
n=3 Participants
Participants will receive SPG blocks with ropivacaine
Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA
|
Placebo (Saline)
n=3 Participants
Participants will receive SPG blocks with placebo (saline)
Placebo: Placebo Saline using the Sphenocath device- cleared by FDA
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
10 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
7 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=10 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 8 monthsReduction in headache days from baseline to month 8 of treatment as self- reported by the patients (yes/no) and as per headache diary and retrospective charts review documentation
Outcome measures
| Measure |
Lidocaine
n=3 Participants
Participants will receive SPG blocks with lidocaine.
Lidocaine: Nasal application using the Sphenocath device- cleared by FDA
|
Bupivacaine
n=1 Participants
Participants will receive SPG blocks with bupivacaine
Bupivacaine: Nasal application using the Sphenocath device- cleared by FDA
|
Ropivacaine
n=3 Participants
Participants will receive SPG blocks with ropivacaine
Ropivacaine: Nasal application using the Sphenocath device- cleared by FDA
|
Placebo (Saline)
n=3 Participants
Participants will receive SPG blocks with placebo (saline)
Placebo: Placebo Saline using the Sphenocath device- cleared by FDA
|
|---|---|---|---|---|
|
Number of Participants With a Reduction in Headache Days From Baseline to Month 8 of Treatment
|
3 participants
|
1 participants
|
1 participants
|
0 participants
|
Adverse Events
Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Saline)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place