Trial Outcomes & Findings for Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura (NCT NCT00449540)
NCT ID: NCT00449540
Last Updated: 2011-08-15
Results Overview
Number of participants experiencing no pain at two hours post-treatment divided by total number of participants treated. For each treated aura episode during the migraine treatment phase, the subjects rated the pain intensity of their headache as none, mild, moderate or severe at baseline (before application of the study device) at 30 minutes, and at 1, 2, 24, and 48 hours posttreatement.
COMPLETED
PHASE3
201 participants
Two hours
2011-08-15
Participant Flow
267 participants enrolled in the 30 day Lead-In phase as described. 66 participants did not experience migraine in the 30 days allotted and therefore were not moved to the treatment phase. 201 participants were moved to the treatment phase
Participant milestones
| Measure |
30 Day Lead in Phase
some particpants did not experience migrain in the 30 days allotted and therefore were not moved to the treatment phase
|
Active TMS
Active Transcranial Magnetic Stimulation Device
|
Sham TMS Device
Device which does not deliver TMS pulse
|
|---|---|---|---|
|
Pretreatment Phase
STARTED
|
267
|
0
|
0
|
|
Pretreatment Phase
COMPLETED
|
201
|
0
|
0
|
|
Pretreatment Phase
NOT COMPLETED
|
66
|
0
|
0
|
|
Treatment Phase
STARTED
|
0
|
102
|
99
|
|
Treatment Phase
COMPLETED
|
0
|
82
|
82
|
|
Treatment Phase
NOT COMPLETED
|
0
|
20
|
17
|
Reasons for withdrawal
| Measure |
30 Day Lead in Phase
some particpants did not experience migrain in the 30 days allotted and therefore were not moved to the treatment phase
|
Active TMS
Active Transcranial Magnetic Stimulation Device
|
Sham TMS Device
Device which does not deliver TMS pulse
|
|---|---|---|---|
|
Pretreatment Phase
No migraine experienced
|
66
|
0
|
0
|
|
Treatment Phase
did not experience or treat migraine
|
0
|
20
|
17
|
Baseline Characteristics
Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura
Baseline characteristics by cohort
| Measure |
Active Transcranial Magnetic Stimulation (TMS) Device
n=102 Participants
Active Transcranial Magnetic Stimulation Device Treatment
|
Sham TMS Device
n=99 Participants
Simulated Sham treatment without TMS
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
102 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
38.8 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 10.83 • n=7 Participants
|
39.4 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=5 Participants
|
99 participants
n=7 Participants
|
201 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two hoursPopulation: Full-analysis set: intention to treat population (201) adjusted for those participants who did not administer treatment during the study period
Number of participants experiencing no pain at two hours post-treatment divided by total number of participants treated. For each treated aura episode during the migraine treatment phase, the subjects rated the pain intensity of their headache as none, mild, moderate or severe at baseline (before application of the study device) at 30 minutes, and at 1, 2, 24, and 48 hours posttreatement.
Outcome measures
| Measure |
Active Transcranial Magnetic Stimulation (TMS) Device
n=82 Participants
Active Transcranial Magnetic Stimulation Device Treatment
|
Sham TMS Device
n=82 Participants
Simulated Sham treatment without TMS
|
|---|---|---|
|
Percentage of Participants Experiencing no Pain at Two Hours Post-treatment
|
39 percentage of participants
|
22 percentage of participants
|
SECONDARY outcome
Timeframe: two hours post treatmentPercentage of participants who have symptoms of nausea two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.
Outcome measures
| Measure |
Active Transcranial Magnetic Stimulation (TMS) Device
n=82 Participants
Active Transcranial Magnetic Stimulation Device Treatment
|
Sham TMS Device
n=82 Participants
Simulated Sham treatment without TMS
|
|---|---|---|
|
Percentage of Participants Who Have Symptoms of Nausea
|
38 percentage of participants
|
40 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours post treatmentPercentage of participants who have symptoms of phonophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.
Outcome measures
| Measure |
Active Transcranial Magnetic Stimulation (TMS) Device
n=82 Participants
Active Transcranial Magnetic Stimulation Device Treatment
|
Sham TMS Device
n=82 Participants
Simulated Sham treatment without TMS
|
|---|---|---|
|
Percentage of Participants Who Have Symptoms Phonophobia
|
57 Percentage of Participants
|
63 Percentage of Participants
|
SECONDARY outcome
Timeframe: 2 hours post treatmentPercentage of participants who have symptoms of photophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.
Outcome measures
| Measure |
Active Transcranial Magnetic Stimulation (TMS) Device
n=82 Participants
Active Transcranial Magnetic Stimulation Device Treatment
|
Sham TMS Device
n=82 Participants
Simulated Sham treatment without TMS
|
|---|---|---|
|
Percentage of Participants Who Have Photophobia
|
70 Percentage of participants
|
78 Percentage of participants
|
Adverse Events
Active TMS Device - Treatment Related
Sham TMS Device - Treatment Related
Active TMS - Not Treatment Related
Sham TMS Device - Not Treatment Related
Serious adverse events
| Measure |
Active TMS Device - Treatment Related
n=102 participants at risk
Active Transcranial Magnetic Stimulation Device Treatment - Treatment related
|
Sham TMS Device - Treatment Related
n=99 participants at risk
Simulated Sham treatment without TMS
|
Active TMS - Not Treatment Related
n=102 participants at risk
Active Transcranial Magnetic Stimulation Device Treatment - Not treatment related
|
Sham TMS Device - Not Treatment Related
n=99 participants at risk
Sham TMS Device - events that are not treatment related
|
|---|---|---|---|---|
|
Eye disorders
optic neuritis
|
0.00%
0/102
|
0.00%
0/99
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
Other adverse events
| Measure |
Active TMS Device - Treatment Related
n=102 participants at risk
Active Transcranial Magnetic Stimulation Device Treatment - Treatment related
|
Sham TMS Device - Treatment Related
n=99 participants at risk
Simulated Sham treatment without TMS
|
Active TMS - Not Treatment Related
n=102 participants at risk
Active Transcranial Magnetic Stimulation Device Treatment - Not treatment related
|
Sham TMS Device - Not Treatment Related
n=99 participants at risk
Sham TMS Device - events that are not treatment related
|
|---|---|---|---|---|
|
General disorders
Application site pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/102
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/102
|
0.00%
0/99
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Nervous system disorders
Dizzines
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/102
|
0.00%
0/99
|
|
General disorders
Gastric ulcer
|
0.00%
0/102
|
0.00%
0/99
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.00%
0/102
|
0.00%
0/99
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
General disorders
Nausea
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
0.00%
0/102
|
0.00%
0/99
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/102
|
0.00%
0/99
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Nervous system disorders
Palpitations
|
0.00%
0/102
|
0.00%
0/99
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
General disorders
Rash
|
0.00%
0/102
|
0.00%
0/99
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Nervous system disorders
Vertigo
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/102
|
0.00%
0/99
|
|
General disorders
Vomiting
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.00%
0/102
|
0.00%
0/99
|
|
General disorders
Tempromandibular joint syndrome
|
0.00%
0/102
|
0.00%
0/99
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Nervous system disorders
Concussion
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Neck Pain
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
General disorders
Road traffic Accident
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/102
|
0.00%
0/99
|
2.0%
2/102 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
aphasia
|
0.00%
0/102
|
0.00%
0/99
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
General disorders
Sleep disorder
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
0.00%
0/102
|
0.00%
0/99
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60