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.
