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Pilot Study of VVD-101 for the Treatment of Delayed Alcohol-Induced Headaches

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ClinicalTrials.gov Identifier: NCT02176655
Recruitment Status : Completed
First Posted : June 27, 2014
Results First Posted : March 23, 2017
Last Update Posted : March 23, 2017
Sponsor:
Collaborator:
Vivid Pharma Inc.
Information provided by (Responsible Party):
Roger K Cady, MD, Cady, Roger, M.D.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Delayed Alcohol Induced Headache
Interventions Drug: VVD-101
Drug: Placebo
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 31
Completed 25
Not Completed 6
Reason Not Completed
Subjects did not treat             6
Arm/Group Title Cross-Over Group
Hide Arm/Group Description

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 Number of Baseline Participants 31
Hide Baseline Analysis Population Description
All subjects randomized to treatment are included in the baseline analysis population, whether or not they treated a headache.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
35.19  (11.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
23
  74.2%
Male
8
  25.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title Headache Severity 2 Hours Post Treatment
Hide Description 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.
Time Frame Immediately Prior to Treatment through 2 Hours Post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VVD-101 Placebo
Hide Arm/Group Description:

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.

One placebo capsule to match taken after the onset of a delayed alcohol induced headache.

Placebo

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-Treatment 2.18  (0.63) 2.09  (0.54)
2 Hours Post-Treatment 0.85  (0.88) 1.17  (0.88)
2.Secondary Outcome
Title Headache Severity at Treatment, 30 Minutes and 1 Hour Post Treatment
Hide Description 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.
Time Frame Immediately Prior to Treatment through 1 Hours Post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VVD-101 Placebo
Hide Arm/Group Description:

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.

One placebo capsule to match taken after the onset of a delayed alcohol induced headache.

Placebo

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-Treatment 2.18  (0.63) 2.09  (0.54)
30 Mintues Post-Treatment 1.78  (0.76) 1.85  (0.74)
1 Hour Post-Treatment 1.20  (0.90) 1.55  (0.82)
3.Secondary Outcome
Title Number of Headaches Relieved
Hide Description 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.
Time Frame Immediately Prior to Treatment to 2 Hours Post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VVD-101 Placebo
Hide Arm/Group Description:

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.

One placebo capsule to match taken after the onset of a delayed alcohol induced headache.

Placebo

Overall Number of Participants Analyzed 25 25
Overall Number of Units Analyzed
Type of Units Analyzed: Headaches
40 47
Measure Type: Number
Unit of Measure: Headaches
30 Minutes Post-Treatment 10 12
1 Hour Post-Treatment 23 17
2 Hours Post-Treatment 30 27
4.Secondary Outcome
Title Number of Headaches Relieved to Complete Pain Freedom at Two Hours Post Treatment
Hide Description 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.
Time Frame Immediately Prior to Treatment to 2 Hours Post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VVD-101 Placebo
Hide Arm/Group Description:

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.

One placebo capsule to match taken after the onset of a delayed alcohol induced headache.

Placebo

Overall Number of Participants Analyzed 25 25
Overall Number of Units Analyzed
Type of Units Analyzed: Headaches
40 47
Measure Type: Number
Unit of Measure: Headaches
15 13
5.Secondary Outcome
Title Number of Headaches With Sustained Pain Freedom at Twenty Four Hours Post Treatment
Hide Description 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.
Time Frame Time of Treatment to 24 Hours Post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VVD-101 Placebo
Hide Arm/Group Description:

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.

One placebo capsule to match taken after the onset of a delayed alcohol induced headache.

Placebo

Overall Number of Participants Analyzed 25 25
Overall Number of Units Analyzed
Type of Units Analyzed: Headaches
16 12
Measure Type: Number
Unit of Measure: Headaches
15 12
6.Secondary Outcome
Title Number of Participants With Consistent Response to VVD-101
Hide Description 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.
Time Frame Response to Treatment of Three Headaches (estimated 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VVD-101
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
9
7.Secondary Outcome
Title Satisfaction
Hide Description 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.
Time Frame 24 Hours Post Treatment for 3 Headaches (estimated 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VVD-101 Placebo
Hide Arm/Group Description:

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.

One placebo capsule to match taken after the onset of a delayed alcohol induced headache.

Placebo

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.75  (2.01) 2.62  (2.12)
8.Secondary Outcome
Title Acute Hangover Scale Compared to Pain Severity 2 Hours Post Treatment
Hide Description 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.
Time Frame Immediately Before Treatment of 3 Headaches to 2 Hours Post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VVD-101
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Acute Hangover Scale Before Treatment 22.98  (11.82)
Headache Pain Severity 2 Hours Post Treatment .85  (.88)
9.Other Pre-specified Outcome
Title Number of Drinks Consumed Compared to Pain Severity 2 Hours Post Treatment
Hide Description 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.
Time Frame Time of Last Sitting to 2 Hours Post Treatment (estimated 14 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VVD-101
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Number of Drinks Consumed
4.71  (2.61)
10.Other Pre-specified Outcome
Title Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment
Hide Description 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.
Time Frame Immediately Before Treatment to 2 Hours Post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VVD-101
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Hangover 3.53  (1.72)
Thirsty 3.5  (1.9)
Tired 3.78  (1.54)
Headache 4.23  (1.47)
Dizziness or Faintness 1.65  (1.77)
Nausea 1.75  (1.83)
Stomach Ache 1.58  (2.01)
Heart Racing 1.10  (1.30)
Loss of Appetite 1.88  (1.86)
Headache Pain Severity 2 Hours Post Treatment .85  (.88)
11.Other Pre-specified Outcome
Title Meaningful Headache Relief
Hide Description Time to meaningful headache relief for VVD-101 vs. placebo. Meaningful headache relief is defined as experiencing substantial relief as reported by the subject.
Time Frame Time of Onset to Meaningful Headache Relief (up to 24 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VVD-101 Placebo
Hide Arm/Group Description:

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.

One placebo capsule to match taken after the onset of a delayed alcohol induced headache.

Placebo

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: minutes
226.33  (268.98) 351.14  (403.01)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Study Participants
Hide Arm/Group Description

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.

All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%) # Events
Total   0/31 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Study Participants
Affected / at Risk (%) # Events
Total   3/31 (9.68%)    
Respiratory, thoracic and mediastinal disorders   
Cold  3/31 (9.68%)  3
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Heather Manley
Organization: Clinvest/A Division of Banyan Group Inc.
Phone: 417-841-3664
Responsible Party: Roger K Cady, MD, Cady, Roger, M.D.
ClinicalTrials.gov Identifier: NCT02176655     History of Changes
Other Study ID Numbers: 14-001VI
First Submitted: June 24, 2014
First Posted: June 27, 2014
Results First Submitted: August 18, 2016
Results First Posted: March 23, 2017
Last Update Posted: March 23, 2017