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

NCT02176655 | Completed Phase 2 Results

• 1 other identifier: 14-001VI
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

This study proposes to compare the efficacy of sumatriptan and aspirin to placebo as an acute abortive treatment for delayed alcohol induced headache in adult subjects.

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)

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-101 DRUG

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

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• currently consume alcohol averaging at least four times per month.
• a negative urine pregnancy test at Visit 1, if female, and of childbearing potential. Note: If of childbearing potential, subject must agree to maintain true abstinence or use (or have their partner use) one of the listed methods of birth control for the duration of the study: hormonal contraceptive, intrauterine device (IUD), condoms, diaphragm, and/or vasectomy. The use of barrier contraceptive (condom or diaphragm) should always be supplemented with the use of a spermicide. Note: To be considered not of childbearing potential, subject must be 6 weeks post-surgical bilateral oophorectomy, hysterectomy, or bilateral tubal ligation, or postmenopausal for at least one year.
• at least a one year history of delayed alcohol-induced headache after light to moderate alcohol consumption.
• able to differentiate delayed alcohol-induced headache from any other headache they may experience (e.g., tension-type headache).
• able to stay awake for at least 2 hours after treatment following first dose of study product.
• willing to complete the online headache diary and questionnaires.
• concomitant medication dosages approved by the investigator.
• internet access and an email address for completion of online diary and questionnaires.

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.

Sponsors & Collaborators

• Cady, Roger, M.D.: lead
• Vivid Pharma Inc.: collaborator

Study Sites (2)

South Drive Medical Clinic

Mountain View, California, 94040, United States

Location

Clinvest

Springfield, Missouri, 65807, United States

Location

MeSH Terms

Interventions

Sumatriptan; Aspirin

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

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

hmanley@clinvest.com

417-841-3664

Study Officials

• Roger K Cady, MD

  Clinvest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 23, 2017
• Results First Posted: March 23, 2017

Record last verified: 2017-03

Locations

US (2)