Trial Outcomes & Findings for Galcanezumab for Vestibular Migraine (NCT NCT04417361)
NCT ID: NCT04417361
Last Updated: 2024-12-10
Results Overview
This is a recently developed and validated outcome measure for vestibular migraine from the investigators. It has been shown to be highly reliable and valid, and responsive to treatment changes. At this point, it is the only disease specific outcome measure for vestibular migraine. Scores are between 0 and 100, with 100 indicating higher levels of disease related suffering.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Change between baseline (month 1) and after treatment (month 4)
Results posted on
2024-12-10
Participant Flow
Participant milestones
| Measure |
Galcanezumab
The galcanezumab arm will self-administer a subcutaneous injection of galcanezumab. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of galcanezumab 120 mg. The injections will be with a pre-loaded syringe containing galcanezumab.
Galcanezumab Prefilled Syringe: Galcanezumab will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
Placebo
The placebo arm will self-administer a subcutaneous injection of placebo. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of placebo 120 mg. The injections will be with a pre-loaded syringe containing placebo.
Placebo: Placebo will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
22
|
|
Overall Study
COMPLETED
|
17
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Galcanezumab
The galcanezumab arm will self-administer a subcutaneous injection of galcanezumab. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of galcanezumab 120 mg. The injections will be with a pre-loaded syringe containing galcanezumab.
Galcanezumab Prefilled Syringe: Galcanezumab will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
Placebo
The placebo arm will self-administer a subcutaneous injection of placebo. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of placebo 120 mg. The injections will be with a pre-loaded syringe containing placebo.
Placebo: Placebo will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
study unexpectedly stopped early due to supply issues with drug/placebo
|
0
|
1
|
Baseline Characteristics
Galcanezumab for Vestibular Migraine
Baseline characteristics by cohort
| Measure |
Galcanezumab
n=18 Participants
The galcanezumab arm will self-administer a subcutaneous injection of galcanezumab. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of galcanezumab 120 mg. The injections will be with a pre-loaded syringe containing galcanezumab.
Galcanezumab Prefilled Syringe: Galcanezumab will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
Placebo
n=22 Participants
The placebo arm will self-administer a subcutaneous injection of placebo. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of placebo 120 mg. The injections will be with a pre-loaded syringe containing placebo.
Placebo: Placebo will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
50.8 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
History of migraine
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Family history of migraine
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Count of triggers
|
9.4 Count of triggers
STANDARD_DEVIATION 7.8 • n=5 Participants
|
8.9 Count of triggers
STANDARD_DEVIATION 7.6 • n=7 Participants
|
9.1 Count of triggers
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Count of associated symptoms
|
4.2 count of associated symptoms
STANDARD_DEVIATION 1.7 • n=5 Participants
|
4.6 count of associated symptoms
STANDARD_DEVIATION 1.3 • n=7 Participants
|
4.4 count of associated symptoms
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
SV2 VM-PATHI score
|
47.3 mean score
STANDARD_DEVIATION 12 • n=5 Participants
|
45.7 mean score
STANDARD_DEVIATION 9.9 • n=7 Participants
|
46.4 mean score
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
SV2 DHI score
|
61.4 mean score
STANDARD_DEVIATION 14.9 • n=5 Participants
|
56.7 mean score
STANDARD_DEVIATION 19.1 • n=7 Participants
|
58.8 mean score
STANDARD_DEVIATION 17.3 • n=5 Participants
|
|
DDD baseline
|
17.9 days
STANDARD_DEVIATION 7.9 • n=5 Participants
|
18 days
STANDARD_DEVIATION 7.6 • n=7 Participants
|
18 days
STANDARD_DEVIATION 7.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change between baseline (month 1) and after treatment (month 4)This is a recently developed and validated outcome measure for vestibular migraine from the investigators. It has been shown to be highly reliable and valid, and responsive to treatment changes. At this point, it is the only disease specific outcome measure for vestibular migraine. Scores are between 0 and 100, with 100 indicating higher levels of disease related suffering.
Outcome measures
| Measure |
Galcanezumab
n=17 Participants
The galcanezumab arm will self-administer a subcutaneous injection of galcanezumab. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of galcanezumab 120 mg. The injections will be with a pre-loaded syringe containing galcanezumab.
Galcanezumab Prefilled Syringe: Galcanezumab will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
Placebo
n=21 Participants
The placebo arm will self-administer a subcutaneous injection of placebo. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of placebo 120 mg. The injections will be with a pre-loaded syringe containing placebo.
Placebo: Placebo will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
|---|---|---|
|
Change in VM-PATHI (Vestibular Migraine-Patient Assessment Tool and Handicap Inventory) Score From Baseline to Month 4
|
-14.8 score on a scale
Standard Deviation 16.1
|
-5.1 score on a scale
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: Change between baseline (month 0) and after treatment (month 4)Participants will receive a daily text message to rate their dizziness from 0 (no dizziness), 1 (mild dizziness), 2 (moderate dizziness), and 3 (severe dizziness). A score of 2 or higher will count as a definitive dizzy day.
Outcome measures
| Measure |
Galcanezumab
n=17 Participants
The galcanezumab arm will self-administer a subcutaneous injection of galcanezumab. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of galcanezumab 120 mg. The injections will be with a pre-loaded syringe containing galcanezumab.
Galcanezumab Prefilled Syringe: Galcanezumab will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
Placebo
n=21 Participants
The placebo arm will self-administer a subcutaneous injection of placebo. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of placebo 120 mg. The injections will be with a pre-loaded syringe containing placebo.
Placebo: Placebo will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
|---|---|---|
|
Change in Number of Definitive Dizzy Days for Participants Measured Daily From Baseline to Month 4 Via Text Message
|
-11.3 days
Standard Deviation 7.2
|
-5.6 days
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Change between baseline (month 0) to after treatment (month 4)Response rates will be measured by the percentage of participants in each arm experiencing a 100%, 75%, 50%, 25%, 0% reduction in definitive dizzy days.
Outcome measures
| Measure |
Galcanezumab
n=17 Participants
The galcanezumab arm will self-administer a subcutaneous injection of galcanezumab. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of galcanezumab 120 mg. The injections will be with a pre-loaded syringe containing galcanezumab.
Galcanezumab Prefilled Syringe: Galcanezumab will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
Placebo
n=21 Participants
The placebo arm will self-administer a subcutaneous injection of placebo. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of placebo 120 mg. The injections will be with a pre-loaded syringe containing placebo.
Placebo: Placebo will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
|---|---|---|
|
Change in Response Rates as Defined by Percentage Reduction in Definitive Dizzy Days Via Text Message From Baseline to Month 4
50% reduction
|
77 percentage of subjects
|
48 percentage of subjects
|
|
Change in Response Rates as Defined by Percentage Reduction in Definitive Dizzy Days Via Text Message From Baseline to Month 4
25% reduction
|
82 percentage of subjects
|
57 percentage of subjects
|
|
Change in Response Rates as Defined by Percentage Reduction in Definitive Dizzy Days Via Text Message From Baseline to Month 4
100% reduction
|
18 percentage of subjects
|
10 percentage of subjects
|
|
Change in Response Rates as Defined by Percentage Reduction in Definitive Dizzy Days Via Text Message From Baseline to Month 4
75% reduction
|
53 percentage of subjects
|
38 percentage of subjects
|
SECONDARY outcome
Timeframe: Change between baseline (month 0) to after treatment (month 4)This is the most widely used measure of dizziness severity, and consists of 25 questions. Questions ask about problems related to dizziness, and are scored as no (0 points), sometimes (2 points), or always (4 points). Total score is between 0 and 100, with higher scores indicating more disability.
Outcome measures
| Measure |
Galcanezumab
n=17 Participants
The galcanezumab arm will self-administer a subcutaneous injection of galcanezumab. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of galcanezumab 120 mg. The injections will be with a pre-loaded syringe containing galcanezumab.
Galcanezumab Prefilled Syringe: Galcanezumab will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
Placebo
n=21 Participants
The placebo arm will self-administer a subcutaneous injection of placebo. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of placebo 120 mg. The injections will be with a pre-loaded syringe containing placebo.
Placebo: Placebo will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
|---|---|---|
|
Change in Dizziness Handicap Inventory Score From Baseline to Month 4
|
-22 score on a scale
Standard Deviation 19.3
|
-8.3 score on a scale
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Change between baseline (month 1) to after treatment (month 4)There are 10 questions on this quality of life measure, each with a score of 1-5. Higher scores correspond to a greater extent of the concept measured (e.g., more fatigue). Two summed scores are generated, one for global mental health (question #3, 6, 7, 8) and one for global physical health (question #2, 4, 5, 10). The remaining 2 questions are analyzed separately. Summed scores for physical health and mental health are converted into T-score values using the "HealthMeasures Scoring Service" available online. The average score for the US population is 50, with a standard deviation of 10. Higher scores indicate better physical and mental health.
Outcome measures
| Measure |
Galcanezumab
n=17 Participants
The galcanezumab arm will self-administer a subcutaneous injection of galcanezumab. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of galcanezumab 120 mg. The injections will be with a pre-loaded syringe containing galcanezumab.
Galcanezumab Prefilled Syringe: Galcanezumab will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
Placebo
n=21 Participants
The placebo arm will self-administer a subcutaneous injection of placebo. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of placebo 120 mg. The injections will be with a pre-loaded syringe containing placebo.
Placebo: Placebo will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System Short Form (PROMIS SF) v1.2- Global Health Scores
physical subscale
|
5.3 t score
Standard Deviation 7
|
1.9 t score
Standard Deviation 6.4
|
|
Change in Patient-Reported Outcomes Measurement Information System Short Form (PROMIS SF) v1.2- Global Health Scores
mental subscale
|
4.8 t score
Standard Deviation 5.3
|
3.2 t score
Standard Deviation 8.3
|
Adverse Events
Galcanezumab
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Galcanezumab
n=18 participants at risk
The galcanezumab arm will self-administer a subcutaneous injection of galcanezumab. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of galcanezumab 120 mg. The injections will be with a pre-loaded syringe containing galcanezumab.
Galcanezumab Prefilled Syringe: Galcanezumab will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
Placebo
n=22 participants at risk
The placebo arm will self-administer a subcutaneous injection of placebo. The first dose (at month 1) will be a loading dose of two injections, or 240 mg in total. After that, at month 2 and month 3, each participant will receive an injection of placebo 120 mg. The injections will be with a pre-loaded syringe containing placebo.
Placebo: Placebo will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
injection site reaction
|
11.1%
2/18 • 4 months
|
0.00%
0/22 • 4 months
|
|
Nervous system disorders
worsening of vestibular migraines
|
11.1%
2/18 • 4 months
|
0.00%
0/22 • 4 months
|
|
Skin and subcutaneous tissue disorders
injection site soreness
|
0.00%
0/18 • 4 months
|
4.5%
1/22 • 4 months
|
|
Skin and subcutaneous tissue disorders
injection site bruising
|
0.00%
0/18 • 4 months
|
4.5%
1/22 • 4 months
|
|
Metabolism and nutrition disorders
subjective weight gain
|
0.00%
0/18 • 4 months
|
4.5%
1/22 • 4 months
|
|
Vascular disorders
low blood pressure
|
0.00%
0/18 • 4 months
|
4.5%
1/22 • 4 months
|
|
Nervous system disorders
increased headaches
|
0.00%
0/18 • 4 months
|
4.5%
1/22 • 4 months
|
|
Skin and subcutaneous tissue disorders
hair loss
|
0.00%
0/18 • 4 months
|
4.5%
1/22 • 4 months
|
|
Cardiac disorders
palpitations
|
0.00%
0/18 • 4 months
|
4.5%
1/22 • 4 months
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/18 • 4 months
|
4.5%
1/22 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place