Trial Outcomes & Findings for Pilot Study of VVD-101 for the Treatment of Delayed Alcohol-Induced Headaches (NCT NCT02176655)
NCT ID: NCT02176655
Last Updated: 2017-03-23
Results Overview
Headache severity 2 hours post treatment in sumatriptan succinate 12.5 mg and acetylsalicylic acid 325 mg (VVD-101) vs. placebo. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.
COMPLETED
PHASE2
31 participants
Immediately Prior to Treatment through 2 Hours Post Treatment
2017-03-23
Participant Flow
Participant milestones
| Measure |
All Study Participants
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache.
|
|---|---|
|
Overall Study
STARTED
|
31
|
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Overall Study
COMPLETED
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25
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Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
All Study Participants
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache.
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|---|---|
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Overall Study
Subjects did not treat
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6
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Baseline Characteristics
Pilot Study of VVD-101 for the Treatment of Delayed Alcohol-Induced Headaches
Baseline characteristics by cohort
| Measure |
Cross-Over Group
n=31 Participants
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache.
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|---|---|
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Age, Continuous
|
35.19 years
STANDARD_DEVIATION 11.29 • n=99 Participants
|
|
Sex: Female, Male
Female
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23 Participants
n=99 Participants
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Sex: Female, Male
Male
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8 Participants
n=99 Participants
|
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Region of Enrollment
United States
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31 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Immediately Prior to Treatment through 2 Hours Post TreatmentPopulation: Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.
Headache severity 2 hours post treatment in sumatriptan succinate 12.5 mg and acetylsalicylic acid 325 mg (VVD-101) vs. placebo. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.
Outcome measures
| Measure |
VVD-101
n=25 Participants
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
|
Placebo
n=25 Participants
One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo
|
|---|---|---|
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Headache Severity 2 Hours Post Treatment
Pre-Treatment
|
2.18 units on a scale
Standard Deviation 0.63
|
2.09 units on a scale
Standard Deviation 0.54
|
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Headache Severity 2 Hours Post Treatment
2 Hours Post-Treatment
|
0.85 units on a scale
Standard Deviation 0.88
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1.17 units on a scale
Standard Deviation 0.88
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SECONDARY outcome
Timeframe: Immediately Prior to Treatment through 1 Hours Post TreatmentPopulation: Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.
Change in headache severity from before treatment, at 30 minutes, and 1 hour post treatment in attacks treated with VVD-101 vs. placebo. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.
Outcome measures
| Measure |
VVD-101
n=25 Participants
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
|
Placebo
n=25 Participants
One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo
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|---|---|---|
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Headache Severity at Treatment, 30 Minutes and 1 Hour Post Treatment
Pre-Treatment
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2.18 units on a scale
Standard Deviation 0.63
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2.09 units on a scale
Standard Deviation 0.54
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|
Headache Severity at Treatment, 30 Minutes and 1 Hour Post Treatment
30 Mintues Post-Treatment
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1.78 units on a scale
Standard Deviation 0.76
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1.85 units on a scale
Standard Deviation 0.74
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Headache Severity at Treatment, 30 Minutes and 1 Hour Post Treatment
1 Hour Post-Treatment
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1.20 units on a scale
Standard Deviation 0.90
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1.55 units on a scale
Standard Deviation 0.82
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SECONDARY outcome
Timeframe: Immediately Prior to Treatment to 2 Hours Post TreatmentPopulation: Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects, with 87 headaches were analyzed for this endpoint.
Headache relief from before treatment, at 30 minutes, 1 hour, and 2 hours post treatment in attacks treated with VVD-101 vs. placebo. Headache relief is defined as a headache going from moderate or severe to mild or no headache or mild headache going to no headache. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.
Outcome measures
| Measure |
VVD-101
n=40 Headaches
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
|
Placebo
n=47 Headaches
One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo
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|---|---|---|
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Number of Headaches Relieved
2 Hours Post-Treatment
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30 Headaches
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27 Headaches
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Number of Headaches Relieved
30 Minutes Post-Treatment
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10 Headaches
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12 Headaches
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Number of Headaches Relieved
1 Hour Post-Treatment
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23 Headaches
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17 Headaches
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SECONDARY outcome
Timeframe: Immediately Prior to Treatment to 2 Hours Post TreatmentPopulation: Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects, with 87 headaches were analyzed for this endpoint.
Number of headaches relieved (no head pain) at 2 hours post treatment for VVD-101 vs. placebo. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.
Outcome measures
| Measure |
VVD-101
n=40 Headaches
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
|
Placebo
n=47 Headaches
One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo
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|---|---|---|
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Number of Headaches Relieved to Complete Pain Freedom at Two Hours Post Treatment
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15 Headaches
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13 Headaches
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SECONDARY outcome
Timeframe: Time of Treatment to 24 Hours Post TreatmentPopulation: Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects, with 28 headaches were analyzed for this endpoint.
Number of headaches with sustained headache pain freedom at 24 hours post treatment for VVD-101 vs. placebo. Sustained headache pain freedom is defined as no pain 2 hours post treatment and headache freedom continuing for 24 hours post treatment without rescue. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.
Outcome measures
| Measure |
VVD-101
n=16 Headaches
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
|
Placebo
n=12 Headaches
One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo
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|---|---|---|
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Number of Headaches With Sustained Pain Freedom at Twenty Four Hours Post Treatment
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15 Headaches
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12 Headaches
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SECONDARY outcome
Timeframe: Response to Treatment of Three Headaches (estimated 6 months)Population: Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.
To assess the consistency of response to VVD-101 over the three active treatments of VVD-101. Consistency is defined as meeting the requirements of headache relief 2 hours post treatment for 2 out of 3 active treated headaches. Headache relief is defined as a headache going from moderate or severe to mild or no headache or mild headache going to no headache. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.
Outcome measures
| Measure |
VVD-101
n=25 Participants
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
|
Placebo
One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo
|
|---|---|---|
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Number of Participants With Consistent Response to VVD-101
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9 participants
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—
|
SECONDARY outcome
Timeframe: 24 Hours Post Treatment for 3 Headaches (estimated 6 months)Population: Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.
To assess subject satisfaction with treatment results comparing VVD-101 vs. placebo. Satisfaction was measured on a 7 point Likert scale whereas 0 = extremely dissatisfied and 6 = extremely satisfied.
Outcome measures
| Measure |
VVD-101
n=25 Participants
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
|
Placebo
n=25 Participants
One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo
|
|---|---|---|
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Satisfaction
|
3.75 units on a scale
Standard Deviation 2.01
|
2.62 units on a scale
Standard Deviation 2.12
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SECONDARY outcome
Timeframe: Immediately Before Treatment of 3 Headaches to 2 Hours Post TreatmentPopulation: Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.
Comparison of Acute Hangover Scale (AHS) score before treatment with headache pain severity 2 hours post treatment for headaches treated with VVD-101. The AHS scale is rated on a score of 0-63. A score of 0 indicates no symptoms and a total score of 63 indicates the maximum number of reported symptoms. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.
Outcome measures
| Measure |
VVD-101
n=25 Participants
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
|
Placebo
One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo
|
|---|---|---|
|
Acute Hangover Scale Compared to Pain Severity 2 Hours Post Treatment
Acute Hangover Scale Before Treatment
|
22.98 units on a scale
Standard Deviation 11.82
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—
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|
Acute Hangover Scale Compared to Pain Severity 2 Hours Post Treatment
Headache Pain Severity 2 Hours Post Treatment
|
.85 units on a scale
Standard Deviation .88
|
—
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OTHER_PRE_SPECIFIED outcome
Timeframe: Time of Last Sitting to 2 Hours Post Treatment (estimated 14 hours)Population: Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.
Comparison of the number of drinks consumed at one sitting with pain severity 2 hours post treatment for headaches treated with VVD-101. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.
Outcome measures
| Measure |
VVD-101
n=25 Participants
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
|
Placebo
One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo
|
|---|---|---|
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Number of Drinks Consumed Compared to Pain Severity 2 Hours Post Treatment
|
4.71 Number of Drinks Consumed
Standard Deviation 2.61
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately Before Treatment to 2 Hours Post TreatmentPopulation: Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.
Comparison of headache severity 2 hours post treatment of headache treated with VVD-101 with each associated hangover symptom items on the AHS taken before treatment. Individual Hangover Symptoms Scores range from 0 \[None\] to 7 \[Incapacitating\]. The AHS scale is rated on a score of 0-63. A score of 0 indicates no symptoms and a total score of 63 indicates the maximum number of reported symptoms.Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.
Outcome measures
| Measure |
VVD-101
n=25 Participants
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
|
Placebo
One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo
|
|---|---|---|
|
Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment
Hangover
|
3.53 units on a scale
Standard Deviation 1.72
|
—
|
|
Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment
Thirsty
|
3.5 units on a scale
Standard Deviation 1.9
|
—
|
|
Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment
Tired
|
3.78 units on a scale
Standard Deviation 1.54
|
—
|
|
Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment
Headache
|
4.23 units on a scale
Standard Deviation 1.47
|
—
|
|
Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment
Dizziness or Faintness
|
1.65 units on a scale
Standard Deviation 1.77
|
—
|
|
Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment
Nausea
|
1.75 units on a scale
Standard Deviation 1.83
|
—
|
|
Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment
Stomach Ache
|
1.58 units on a scale
Standard Deviation 2.01
|
—
|
|
Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment
Heart Racing
|
1.10 units on a scale
Standard Deviation 1.30
|
—
|
|
Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment
Loss of Appetite
|
1.88 units on a scale
Standard Deviation 1.86
|
—
|
|
Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment
Headache Pain Severity 2 Hours Post Treatment
|
.85 units on a scale
Standard Deviation .88
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time of Onset to Meaningful Headache Relief (up to 24 hours)Population: Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.
Time to meaningful headache relief for VVD-101 vs. placebo. Meaningful headache relief is defined as experiencing substantial relief as reported by the subject.
Outcome measures
| Measure |
VVD-101
n=25 Participants
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
|
Placebo
n=25 Participants
One placebo capsule to match taken after the onset of a delayed alcohol induced headache.
Placebo
|
|---|---|---|
|
Meaningful Headache Relief
|
226.33 minutes
Standard Deviation 268.98
|
351.14 minutes
Standard Deviation 403.01
|
Adverse Events
All Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Study Participants
n=31 participants at risk
Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
9.7%
3/31 • Number of events 3
|
Additional Information
Heather Manley
Clinvest/A Division of Banyan Group Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place