Trials Sponsors Conditions Drugs Pricing

Conditions

Delayed Alcohol Induced Headache

Keywords

Delayed Alcohol Induced Headache

Outcome Measures

Primary Outcomes (1)

Headache Severity 2 Hours Post Treatment
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.
Immediately Prior to Treatment through 2 Hours Post Treatment

Secondary Outcomes (7)

Headache Severity at Treatment, 30 Minutes and 1 Hour Post Treatment
Immediately Prior to Treatment through 1 Hours Post Treatment
Number of Headaches Relieved
Immediately Prior to Treatment to 2 Hours Post Treatment
Number of Headaches Relieved to Complete Pain Freedom at Two Hours Post Treatment
Immediately Prior to Treatment to 2 Hours Post Treatment
Number of Headaches With Sustained Pain Freedom at Twenty Four Hours Post Treatment
Time of Treatment to 24 Hours Post Treatment
Number of Participants With Consistent Response to VVD-101
Response to Treatment of Three Headaches (estimated 6 months)
+2 more secondary outcomes

Other Outcomes (3)

Number of Drinks Consumed Compared to Pain Severity 2 Hours Post Treatment
Time of Last Sitting to 2 Hours Post Treatment (estimated 14 hours)
Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment
Immediately Before Treatment to 2 Hours Post Treatment
Meaningful Headache Relief
Time of Onset to Meaningful Headache Relief (up to 24 hours)

Study Arms (2)

VVD-101

ACTIVE COMPARATOR

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.

Drug: VVD-101

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

VVD-101Drug

All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.

Also known as: sumatriptan succinate 12.5 mg & acetylsalicylic acid 325 mg

VVD-101

PlaceboDrug

All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

male or female 21 years or older.
able to read, understand, and sign the informed consent.

Sponsors & Collaborators

Vivid Pharma Inc.
Industrycollaborator
Cady, Roger, M.D.
Individuallead

Study Sites (2)

South Drive Medical Clinic

Mountain View, California, 94040, United States

Clinvest

Springfield, Missouri, 65807, United States

MeSH Terms

Interventions

SumatriptanAspirin

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsTryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSalicylatesHydroxybenzoatesPhenols

Results Point of Contact

Title: Heather Manley
Organization: Clinvest/A Division of Banyan Group Inc.

Study Officials

Roger K Cady, MD
Clinvest
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

31 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDIV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: CEO

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 27, 2014

Study Start

July 2014

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

\> 6 migraine attacks per month during the 3 months previous to screening.
history of receiving partial or complete relief of hangover headaches from 650 mg of aspirin.
history of basilar, ophthalmoplegic, or hemiplegic migraine, cluster headache, or secondary headaches (such as due to trauma, infection, alterations of homeostasis, eye, nose, throat (ENT) disorders, or psychiatric disorders, cranial or cervical disorders or neuralgias) within the previous year.
significant alcohol or drug use problems (score \> 4 on the Simple Screening Instrument for Alcohol and Other Drugs (SSI-AOD)) or history of treatment or counseling for alcohol or drug abuse and or dependence.
used acute headache medication including non-prescription medications, 15 or more days per month during the last 3 months.
pregnant, actively trying to become pregnant, or breastfeeding.
female of childbearing potential not using adequate contraceptive measures.
has a history of serotonin syndrome or in the opinion of the investigator is at an increased risk for developing serotonin syndrome with the use of triptans.
in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or the presence of risk factors including but not limited to hypertension, hypercholesterolemia, smoker, obesity, diabetes, or family history of coronary artery disease).
if female, has migraine with aura, is a smoker, and currently taking estrogen containing birth control pill, and in the investigator's opinion, is at high risk for cerebrovascular disease.
uncontrolled hypertension (≥140/90 mmHg in either systolic or diastolic in 2 out of 3 blood pressure measurements at screening).
history of any clinically significant medical or psychiatric condition, or evidence of substance abuse including binge drinking within the last year that, in the opinion of the investigator, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this study.
has hypersensitivity, intolerance, or contraindication to the use of any triptan or aspirin (including all sumatriptan and aspirin preparations).
has history of nasal polyps and/or asthma and in the investigator's opinion is at risk for hypersensitivity to aspirin.
participated in an investigational drug trial within the past 30 days.
+2 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Other Outcomes (3)

Study Arms (2)

VVD-101

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Other Outcomes (3)

Study Arms (2)

VVD-101

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations