Delayed Alcohol Induced Headache Clinical Trial
Official title:
Multi-Center, Double-Blind, Placebo Controlled Pilot Study of VVD-101 for the Treatment of Delayed Alcohol-Induced Headaches
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.
The exploratory study will be conducted at 2 investigational sites. Approximately 26
subjects, 21 years of age and older, with a history of delayed alcohol induced headache, as
defined by International Classification of Headache Disorders (ICHD-3 beta) will be
enrolled. The study will consist of two visits. Subject participation will last
approximately 6 months.
At the screening visit (Visit 1), and before any study procedures, an informed consent will
be obtained from the subject. A physical, neurological exam, medication history, and
pregnancy test (if appropriate) will be performed. Vital signs will be recorded for all
subjects. Subjects will also complete the Simple Screening Instrument for Alcohol and Other
Drugs (SSI-AOD).
Subjects scoring greater than 4 (not including items 1 and 15) on the SSI-AOD, at Visit 1,
will not be eligible for this study and will be referred to their primary care provider for
follow up.
Subjects meeting eligibility criteria will be randomized into 1 of 6 different groups. Each
group will receive 3 doses of active drug and 3 doses of placebo in a different order to
treat up to 6 delayed alcohol-induced headaches. Study product instructions will be
reviewed. A copy of the instructions will be given to the subject. Subjects will be
instructed they may take their investigator approved routine rescue medications for
headaches 2 hours after taking the study medication if needed. Rescue medication usage and
dosage will be recorded on the headache diary. Subjects may take acute headache medications
as prescribed; however, this should be recorded on the headache diary. Therapy considered
necessary for the subject's welfare may be given at the discretion of the investigator.
Routine medications should be maintained on a stable dose and regimen for the duration of
the study period.
Subjects will be instructed regarding completion of the online Headache Diary to document
treatment response of up to 6 delayed alcohol-induced headaches. Subjects will be provided
instructions for completing the Headache Diary. The Headache Diary will be completed during
each headache and will document the number of drinks consumed in the last sitting, time of
last drink consumed, pain severity, headache symptoms, and hangover symptoms before
treatment, time of treatment with study products, pain severity at 30 minutes, 1, 2, and 24
hours following treatment, time of headache resolution, and time of meaningful headache
relief. The Headache Diary will also include questions to evaluate subject satisfaction with
study product. Subjects must be headache-free for 24 hours before recording the onset of and
treating another headache. Subjects will be phoned monthly during the study to assess
compliance, continued understanding, and to collect any adverse events.
Visit 2 will occur within 1 week following treatment of a 6th attack or between 180-187 days
following Visit 1, whichever occurs first. The medical and medication history will be
updated and adverse events will be collected. A urine pregnancy test will be performed if
appropriate and vital signs to include weight and height will be performed. Subjects will
complete the SSI-AOD. Subjects scoring greater than 4 (not including items 1 and 15) on the
SSI-AOD will be referred to their primary care provider for follow up. The Diary will be
reviewed and any unused study product and used packaging will be collected. Drug
accountability will be performed.
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