Trial Outcomes & Findings for Trial of Nortriptyline and Topiramate in the Initial Treatment of Vestibular Migraine (NCT NCT02169830)
NCT ID: NCT02169830
Last Updated: 2021-04-23
Results Overview
Changes in Migraine Specific Quality of LIfe (MSQ) and Dizziness Handicap Inventory (DHI) between groups
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
one year
Results posted on
2021-04-23
Participant Flow
35 patients were screened between August 2014 and November 2016.
33 of 35 began the study with diet modification. 2 subjects who were fully consented dropped out of the study before randomization.
Participant milestones
| Measure |
Nortriptyline
Diet modification - nortriptyline and then if necessary topiramate
nortriptyline: The nortriptyline will be given in an escalating fashion, starting at 25 mg PO qhs for 2 weeks, followed by 50 mg PO qhs for 2 weeks, and finally 75 mg PO qhs. Patients will be encouraged to use the lowest effective dose and to self-titrate their medication.
|
Topiramate
Diet Modification topiramate and then nortriptyline if necessary
Topiramate: Topiramate dosing will be 25 mg PO qhs for 1 week, followed by 25 mg BID for 1 week, followed by 25 mg in the morning and 50 mg qhs for 1 week, and finally 50 mg BID
|
Diet Modification
Emphasis will be given to cessation of known migraine triggers such as caffeine, sodas, chocolates, alcohol (especially red wine) and aged cheeses. Patients who have complete control of their symptoms with diet and behavior modification alone will be followed for a total of 4 months to determine the durability of symptom relief.
|
|---|---|---|---|
|
Diet Intervention (4 Weeks)
STARTED
|
0
|
0
|
33
|
|
Diet Intervention (4 Weeks)
COMPLETED
|
0
|
0
|
32
|
|
Diet Intervention (4 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
|
Second Intervention (8 Weeks)
STARTED
|
12
|
5
|
0
|
|
Second Intervention (8 Weeks)
COMPLETED
|
9
|
0
|
0
|
|
Second Intervention (8 Weeks)
NOT COMPLETED
|
3
|
5
|
0
|
|
Third Intervention (8 Weeks)
STARTED
|
0
|
4
|
0
|
|
Third Intervention (8 Weeks)
COMPLETED
|
0
|
2
|
0
|
|
Third Intervention (8 Weeks)
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Nortriptyline
Diet modification - nortriptyline and then if necessary topiramate
nortriptyline: The nortriptyline will be given in an escalating fashion, starting at 25 mg PO qhs for 2 weeks, followed by 50 mg PO qhs for 2 weeks, and finally 75 mg PO qhs. Patients will be encouraged to use the lowest effective dose and to self-titrate their medication.
|
Topiramate
Diet Modification topiramate and then nortriptyline if necessary
Topiramate: Topiramate dosing will be 25 mg PO qhs for 1 week, followed by 25 mg BID for 1 week, followed by 25 mg in the morning and 50 mg qhs for 1 week, and finally 50 mg BID
|
Diet Modification
Emphasis will be given to cessation of known migraine triggers such as caffeine, sodas, chocolates, alcohol (especially red wine) and aged cheeses. Patients who have complete control of their symptoms with diet and behavior modification alone will be followed for a total of 4 months to determine the durability of symptom relief.
|
|---|---|---|---|
|
Diet Intervention (4 Weeks)
Lost to Follow-up
|
0
|
0
|
1
|
|
Second Intervention (8 Weeks)
Lost to Follow-up
|
1
|
0
|
0
|
|
Second Intervention (8 Weeks)
Withdrawal by Subject
|
2
|
5
|
0
|
|
Third Intervention (8 Weeks)
Lost to Follow-up
|
0
|
1
|
0
|
|
Third Intervention (8 Weeks)
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Data was not intended to be nor was it collected.
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: one yearPopulation: No data was collected.
Changes in Migraine Specific Quality of LIfe (MSQ) and Dizziness Handicap Inventory (DHI) between groups
Outcome measures
Outcome data not reported
Adverse Events
Nortriptyline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Topiramate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diet Modification
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