Trial Outcomes & Findings for Drug and Non-Drug Treatment Of Severe Migraine (NCT NCT00910689)
NCT ID: NCT00910689
Last Updated: 2016-11-22
Results Overview
Change in number of migraine episodes(with 24 hours pain free period required between episodes)per 30 days from OAT run-in (Month 1) to Month 10.Obtained from daily electronic diary.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
232 participants
Primary outcome timeframe
Change from Month 1 to Month 10
Results posted on
2016-11-22
Participant Flow
Outpatient clinics
5 week Optimal Acute Therapy (OAT) Run in (M1) precedes random assignment (see detailed design description).
Participant milestones
| Measure |
OAT + Placebo (PL)
Optimal Acute Therapy plus Beta Blocker Placebo
|
OAT + Beta Blocker (Beta-B)
Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
|
OAT + BMM + PL
Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
|
OAT + BMM + Beta-B
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
|
|---|---|---|---|---|
|
Month 1: Optimal Acute Therapy Run in
STARTED
|
55
|
53
|
55
|
69
|
|
Month 1: Optimal Acute Therapy Run in
COMPLETED
|
53
|
52
|
50
|
59
|
|
Month 1: Optimal Acute Therapy Run in
NOT COMPLETED
|
2
|
1
|
5
|
10
|
|
Month 2- 4: Treatment Period
STARTED
|
53
|
52
|
50
|
59
|
|
Month 2- 4: Treatment Period
COMPLETED
|
44
|
42
|
42
|
48
|
|
Month 2- 4: Treatment Period
NOT COMPLETED
|
9
|
10
|
8
|
11
|
|
Months 5 - 10: Evaluation Period I
STARTED
|
44
|
42
|
42
|
48
|
|
Months 5 - 10: Evaluation Period I
COMPLETED
|
40
|
35
|
35
|
41
|
|
Months 5 - 10: Evaluation Period I
NOT COMPLETED
|
4
|
7
|
7
|
7
|
|
Months 11- 16: Evaluation Period II
STARTED
|
40
|
35
|
35
|
41
|
|
Months 11- 16: Evaluation Period II
COMPLETED
|
30
|
25
|
28
|
35
|
|
Months 11- 16: Evaluation Period II
NOT COMPLETED
|
10
|
10
|
7
|
6
|
Reasons for withdrawal
| Measure |
OAT + Placebo (PL)
Optimal Acute Therapy plus Beta Blocker Placebo
|
OAT + Beta Blocker (Beta-B)
Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
|
OAT + BMM + PL
Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
|
OAT + BMM + Beta-B
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
|
|---|---|---|---|---|
|
Month 1: Optimal Acute Therapy Run in
No Post OAT Run-in data
|
2
|
1
|
5
|
10
|
|
Month 2- 4: Treatment Period
Lost to Follow-up
|
3
|
4
|
1
|
3
|
|
Month 2- 4: Treatment Period
Adverse Event
|
2
|
3
|
2
|
0
|
|
Month 2- 4: Treatment Period
Time Demands
|
1
|
0
|
4
|
8
|
|
Month 2- 4: Treatment Period
Lack of Efficacy
|
2
|
1
|
0
|
0
|
|
Month 2- 4: Treatment Period
Perceived Improvement
|
0
|
0
|
1
|
0
|
|
Month 2- 4: Treatment Period
Pregnancy
|
0
|
2
|
0
|
0
|
|
Month 2- 4: Treatment Period
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Months 5 - 10: Evaluation Period I
Lost to Follow-up
|
2
|
5
|
1
|
1
|
|
Months 5 - 10: Evaluation Period I
Adverse Event
|
1
|
0
|
2
|
4
|
|
Months 5 - 10: Evaluation Period I
Lack of Efficacy
|
0
|
1
|
1
|
1
|
|
Months 5 - 10: Evaluation Period I
Protocol Violation
|
1
|
1
|
0
|
0
|
|
Months 5 - 10: Evaluation Period I
Pregnancy
|
0
|
0
|
2
|
0
|
|
Months 5 - 10: Evaluation Period I
Time Demands
|
0
|
0
|
1
|
1
|
|
Months 11- 16: Evaluation Period II
Lost to Follow-up
|
3
|
0
|
1
|
2
|
|
Months 11- 16: Evaluation Period II
Adverse Event
|
2
|
4
|
2
|
2
|
|
Months 11- 16: Evaluation Period II
Pregnancy
|
1
|
0
|
0
|
0
|
|
Months 11- 16: Evaluation Period II
Lack of Efficacy
|
2
|
3
|
3
|
1
|
|
Months 11- 16: Evaluation Period II
Time Demands
|
2
|
1
|
0
|
0
|
|
Months 11- 16: Evaluation Period II
Perceived Improvement
|
0
|
0
|
0
|
1
|
|
Months 11- 16: Evaluation Period II
Physician Decision
|
0
|
2
|
1
|
0
|
Baseline Characteristics
Drug and Non-Drug Treatment Of Severe Migraine
Baseline characteristics by cohort
| Measure |
OAT + Placebo (PL)
n=55 Participants
Optimal Acute Therapy plus Beta Blocker Placebo
|
OAT + Beta Blocker (Beta-B)
n=53 Participants
Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
|
OAT + BMM + PL
n=55 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
|
OAT + BMM + Beta-B
n=69 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
|
Total
n=232 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
232 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
37.1 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
38.2 years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
184 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
53 participants
n=7 Participants
|
55 participants
n=5 Participants
|
69 participants
n=4 Participants
|
232 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Change from Month 1 to Month 10Population: Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.
Change in number of migraine episodes(with 24 hours pain free period required between episodes)per 30 days from OAT run-in (Month 1) to Month 10.Obtained from daily electronic diary.
Outcome measures
| Measure |
OAT + Placebo (PL)
n=55 Participants
Optimal Acute Therapy plus Beta Blocker Placebo
|
OAT + Beta Blocker (Beta-B)
n=53 Participants
Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
|
OAT + BMM + PL
n=55 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
|
OAT + BMM + Beta-B
n=69 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
|
|---|---|---|---|---|
|
Change in Number of Migraine Episodes Per 30 Days at Month 10.
|
-2.1 Number of Migraine episodes
Interval -2.2 to -1.9
|
-2.1 Number of Migraine episodes
Interval -2.2 to -1.9
|
-2.2 Number of Migraine episodes
Interval -2.4 to -2.0
|
-3.3 Number of Migraine episodes
Interval -3.5 to -3.2
|
SECONDARY outcome
Timeframe: Change from Month 1 to Month 10Population: Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.
Change in the number of days with migraine per 30 days at Month 10 relative to the OAT Run-in (Month 1). Obtained from daily electronic diary.
Outcome measures
| Measure |
OAT + Placebo (PL)
n=55 Participants
Optimal Acute Therapy plus Beta Blocker Placebo
|
OAT + Beta Blocker (Beta-B)
n=53 Participants
Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
|
OAT + BMM + PL
n=55 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
|
OAT + BMM + Beta-B
n=69 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
|
|---|---|---|---|---|
|
Change in the Number of Migraine Days Per 30 Days at Month 10
|
-3.3 Number of days
Interval -3.6 to -3.0
|
-3.9 Number of days
Interval -4.2 to -3.5
|
-3.3 Number of days
Interval -3.7 to -2.9
|
-5.4 Number of days
Interval -5.6 to -5.2
|
SECONDARY outcome
Timeframe: Change from Month 1 to Month 10Population: Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.
Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores at Month 10 relative to OAT run-in (Month 1). The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment.
Outcome measures
| Measure |
OAT + Placebo (PL)
n=55 Participants
Optimal Acute Therapy plus Beta Blocker Placebo
|
OAT + Beta Blocker (Beta-B)
n=53 Participants
Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
|
OAT + BMM + PL
n=55 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
|
OAT + BMM + Beta-B
n=69 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
|
|---|---|---|---|---|
|
Change in Quality of Life at Month 10
|
-7.1 Scores on a scale
Interval -7.8 to -6.3
|
-7.1 Scores on a scale
Interval -7.7 to -6.6
|
-8.6 Scores on a scale
Interval -8.9 to -8.2
|
-13.0 Scores on a scale
Interval -13.5 to -12.5
|
SECONDARY outcome
Timeframe: Change from Month 1 to Month 16Population: Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.
Change in number of migraine episodes (with 24 hours pain free period required between episodes) per 30 days from OAT run-in (Month 1) to Month 16. Assessed by participant daily electronic diary.
Outcome measures
| Measure |
OAT + Placebo (PL)
n=55 Participants
Optimal Acute Therapy plus Beta Blocker Placebo
|
OAT + Beta Blocker (Beta-B)
n=53 Participants
Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
|
OAT + BMM + PL
n=55 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
|
OAT + BMM + Beta-B
n=69 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
|
|---|---|---|---|---|
|
Change in Number of Migraine Episodes Per 30 Days at Month 16.
|
-2.5 Number of Migraine Episodes
Interval -2.6 to -2.3
|
-2.5 Number of Migraine Episodes
Interval -2.8 to -2.2
|
-2.7 Number of Migraine Episodes
Interval -2.9 to -2.5
|
-3.8 Number of Migraine Episodes
Interval -4.0 to -3.5
|
SECONDARY outcome
Timeframe: Change form Month 1 to Month 16Population: Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.
Change in the number of migraine days per 30 days at Month 16 relative to the OAT run-in (Month 1). Assessed by participant electronic diary.
Outcome measures
| Measure |
OAT + Placebo (PL)
n=55 Participants
Optimal Acute Therapy plus Beta Blocker Placebo
|
OAT + Beta Blocker (Beta-B)
n=53 Participants
Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
|
OAT + BMM + PL
n=55 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
|
OAT + BMM + Beta-B
n=69 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
|
|---|---|---|---|---|
|
Change in the Number of Migraine Days Per 30 Days at Month 16
|
-3.9 Number of Days
Interval -4.3 to -3.5
|
-4.5 Number of Days
Interval -5.1 to -4.0
|
-4.1 Number of Days
Interval -4.5 to -3.8
|
-6.1 Number of Days
Interval -6.6 to -5.6
|
SECONDARY outcome
Timeframe: Change from Month 1 to Month 16Population: Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.
Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores relative to OAT run-in. The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment.
Outcome measures
| Measure |
OAT + Placebo (PL)
n=55 Participants
Optimal Acute Therapy plus Beta Blocker Placebo
|
OAT + Beta Blocker (Beta-B)
n=53 Participants
Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
|
OAT + BMM + PL
n=55 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
|
OAT + BMM + Beta-B
n=69 Participants
Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
|
|---|---|---|---|---|
|
Change in Quality of Life at Month 16
|
-8.8 Scores on a scale
Interval -9.5 to -8.1
|
-8.5 Scores on a scale
Interval -9.4 to -7.6
|
-9.6 Scores on a scale
Interval -10.3 to -9.0
|
-15.2 Scores on a scale
Interval -16.0 to -14.4
|
Adverse Events
OAT + Placebo (PL) at Month 5
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
OAT + Beta-Blocker at Month 5
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
OAT + BMM + PL at Month 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OAT + BMM + Beta-Blocker at Month 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OAT + Placebo (PL) at Month 5
n=55 participants at risk
Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/ Nadolol)Placebo. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or Other side effect at Month 5 following dose adjustment.
|
OAT + Beta-Blocker at Month 5
n=53 participants at risk
Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/Nadolol. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect assessed after dose adjustment(Month 5).
|
OAT + BMM + PL at Month 5
n=55 participants at risk
Optimal Acute Therapy + Behavioral Migraine Management(BMM) + Beta-Blocker(Propranolol/Nadolol) Placebo.
Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect)as assessed after dose adjustment(Month 5).
|
OAT + BMM + Beta-Blocker at Month 5
n=69 participants at risk
Optimal Acute Therapy (OAT)+ Behavioral Migraine Management (BMM)+ Beta-Blocker(Propranolol/Nadolol).
Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side effect) assessed after dose adjustment(Month 5).
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
6.8%
3/44 • Number of events 3
|
16.7%
7/42 • Number of events 7
|
4.8%
2/42 • Number of events 2
|
4.2%
2/48 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place