Trial Outcomes & Findings for Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches (NCT NCT01294046)
NCT ID: NCT01294046
Last Updated: 2017-04-14
Results Overview
Pain is rated at stimulation and 2 hours after stimulation initiated based on four point categorical scale, FDA-approved, where 0 = no headache pain, 1= mild pain, 2 = moderate pain, 3 = severe pain. This scale has been used since 1991 for all regulatory submission migraine protocols. Each migraine is categorized in a binary fashion as meeting the endpoint at 2 hours. Migraine relief or Pain relief is defined as moving from pain levels of 3 to 2 down to 1 or 0.
COMPLETED
NA
3 participants
8.5 Months
2017-04-14
Participant Flow
Protocol required 3 subjects who were from the Cleveland Clinic migraine patient population.
This is a one arm study
Participant milestones
| Measure |
Deep Brain Stimulation Arm Group
Electrical Stimulation of SPG for Treatment of Migraine
Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Deep Brain Stimulation Arm Group
Electrical Stimulation of SPG for Treatment of Migraine
Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches
|
|---|---|
|
Overall Study
Infection and surgical explant
|
1
|
|
Overall Study
Eligibility criteria expanded
|
1
|
|
Overall Study
Stimulation response inadqequate
|
1
|
Baseline Characteristics
Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches
Baseline characteristics by cohort
| Measure |
Deep Brain Stimulation Arm Group
Electrical Stimulation of SPG for Treatment of Migraine
Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches
|
|---|---|
|
Age, Categorical
<=18 years
|
0
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0
n=5 Participants
|
PRIMARY outcome
Timeframe: 8.5 MonthsPopulation: No data were collected from this entire study, so no data were analyzed.
Pain is rated at stimulation and 2 hours after stimulation initiated based on four point categorical scale, FDA-approved, where 0 = no headache pain, 1= mild pain, 2 = moderate pain, 3 = severe pain. This scale has been used since 1991 for all regulatory submission migraine protocols. Each migraine is categorized in a binary fashion as meeting the endpoint at 2 hours. Migraine relief or Pain relief is defined as moving from pain levels of 3 to 2 down to 1 or 0.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8.5 MonthsPopulation: No data were collected from this entire study, so no data were analyzed.
Each migraine will be categorized as meeting the endpoint of migraine free if there is a reduction in the migraine grade to 0 for pain with no nausea, photophobia and phonophobia at 2 hours after initiation of stimulation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8.5 monthsPopulation: No data were collected from this entire study, so no data were analyzed.
As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8.5 monthsPopulation: No data were collected from this entire study, so no data were analyzed.
During the baseline period, subjects will record their acute as-needed migraine relief medication use for each attack by drug, dose, route, and frequency. A secondary endpoint for this phase is a reduction in acute migraine medication usage for each attack for drug, dose, route, and frequency during the last month of the study as compared to the baseline month.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8.5 monthsPopulation: No data were collected from this entire study, so no data were analyzed.
The Headache Impact Test -6 (HIT-6) is a validated tool for evaluating headache impact and disability across 6 domains, which will be recorded at baseline and at study conclusion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8.5 monthsPopulation: No data were collected from this entire study, so no data were analyzed.
The Migraine Disability Assessment Scale (MIDAS) is a validated tool that assesses how many days in the last 3 months a patient had at least 50% disability at work, home, school, or recreational activities due to migraine. MIDAS will be assessed at baseline and after study conclusion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8.5 monthsPopulation: No data were collected from this entire study, so no data were analyzed.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8.5 monthsPopulation: No data were collected from this entire study, so no data were analyzed.
During the baseline period, subjects will record the number of migraine days (as defined by the FDA-approved International Classification of Headache Disorders, 2d Edition definition of migraine with and without aura) during the month. The primary endpoint for this phase is a reduction in the number of migraine days during the last month of the study as compared to the baseline month.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8.5 monthsPopulation: No data were collected from this entire study, so no data were analyzed.
As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8.5 monthsPopulation: No data were collected from this entire study, so no data were analyzed.
Presence or absence of nausea, vomiting, photophobia, and phonophobia will be assessed at baseline and after stimulation at 2 hours for each stimulation for each individual.
Outcome measures
Outcome data not reported
Adverse Events
Deep Brain Stimulation Arm Group
Serious adverse events
| Measure |
Deep Brain Stimulation Arm Group
n=1 participants at risk
Electrical Stimulation of SPG for Treatment of Migraine
Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches
|
|---|---|
|
Nervous system disorders
Infection and surgical explant
|
100.0%
1/1 • Number of events 1 • 1 month, the time between implant and explant which was performed due to subject infection. No treatment period occurred.
There was one adverse event which was an infection which required the explant surgery. Full report was made to the FDA and the IRB of this adverse event. The other two subjects who were consented and enrolled did not receive any treatment and no adverse events were noted.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place