Delayed Alcohol Induced HeadachePhase 2NCT02176655
Pilot Study of VVD-101 for the Treatment of Delayed Alcohol-Induced Headaches
A Phase 2 study testing VVD-101 in people with Delayed Alcohol Induced Headache, run by Cady, Roger, M.D. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Delayed Alcohol Induced Headache
- What is being tested?
- VVD-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Jan 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- > 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.
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- 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.
- planning or requiring surgery during the study.
- history of poor compliance with medical treatment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
South Drive Medical Clinic
Mountain View, California, 94040
Clinvest
Springfield, Missouri, 65807
About this study
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.
Read the detailed description
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.
- Conditions
- Delayed Alcohol Induced Headache
- Being tested
- VVD-101, Placebo
- Keywords
- Delayed Alcohol Induced Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VVD-101Drug
Also called 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.
PlaceboDrug
All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: VVD-101 |
| Placebo | Placebo comparator | One placebo capsule to match taken after the onset of a delayed alcohol induced headache. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately Prior to Treatment through 2 Hours Post Treatment
Secondary outcomes (7)
Headache Severity at Treatment, 30 Minutes and 1 Hour Post Treatment
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.
Measured: Immediately Prior to Treatment through 1 Hours Post Treatment
Number of Headaches Relieved
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.
Measured: Immediately Prior to Treatment to 2 Hours Post Treatment
Number of Headaches Relieved to Complete Pain Freedom at Two Hours Post Treatment
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.
Measured: Immediately Prior to Treatment to 2 Hours Post Treatment
Number of Headaches With Sustained Pain Freedom at Twenty Four Hours Post Treatment
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.
Measured: Time of Treatment to 24 Hours Post Treatment
Number of Participants With Consistent Response to VVD-101
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.
Measured: Response to Treatment of Three Headaches (estimated 6 months)
Satisfaction
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.
Measured: 24 Hours Post Treatment for 3 Headaches (estimated 6 months)
Acute Hangover Scale Compared to Pain Severity 2 Hours Post Treatment
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.
Measured: Immediately Before Treatment of 3 Headaches to 2 Hours Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Delayed Alcohol Induced HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cady, Roger, M.D.
- Collaborators
- Vivid Pharma Inc.
- Responsible party
- Principal investigator, Roger K Cady, MD, Cady, Roger, M.D.
- Investigators
- Roger K Cady, MD, Principal investigator, Clinvest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176655
- Sponsor's protocol ID
- 14-001VI
- Status last verified
- Mar 2017
- First submitted
- 24 Jun 2014
- Last updated
- 23 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Double-Blind, Placebo Controlled Pilot Study of VVD-101 for the Treatment of Delayed Alcohol-Induced Headaches
- ClinicalTrials.gov ID
- NCT02176655
- Acronym / sponsor ID
- 14-001VI
- Conditions
- Delayed Alcohol Induced Headache
- Keywords
- Delayed Alcohol Induced Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cady, Roger, M.D.
- Collaborators
- Vivid Pharma Inc.
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Posted 23 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VVD-101 | Active comparator | Drug: VVD-101One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache. |
| Placebo | Placebo comparator | Drug: PlaceboOne placebo capsule to match taken after the onset of a delayed alcohol induced headache. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- > 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VVD-101Also: sumatriptan succinate 12.5 mg & acetylsalicylic acid 325 mgAll subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order. | Drug | VVD-101 |
| PlaceboAll subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order. | Drug | Placebo |
Primary outcome
Headache Severity 2 Hours Post Treatment
Time frame: Immediately Prior to Treatment through 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.
7 secondary outcomes
Headache Severity at Treatment, 30 Minutes and 1 Hour Post Treatment
Time frame: Immediately Prior to Treatment through 1 Hours Post Treatment
Number of Headaches Relieved
Time frame: Immediately Prior to Treatment to 2 Hours Post Treatment
Number of Headaches Relieved to Complete Pain Freedom at Two Hours Post Treatment
Time frame: Immediately Prior to Treatment to 2 Hours Post Treatment
Number of Headaches With Sustained Pain Freedom at Twenty Four Hours Post Treatment
Time frame: Time of Treatment to 24 Hours Post Treatment
Number of Participants With Consistent Response to VVD-101
Time frame: Response to Treatment of Three Headaches (estimated 6 months)
Satisfaction
Time frame: 24 Hours Post Treatment for 3 Headaches (estimated 6 months)
Acute Hangover Scale Compared to Pain Severity 2 Hours Post Treatment
Time frame: Immediately Before Treatment of 3 Headaches to 2 Hours Post Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger K Cady, MD principal investigator
Clinvest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VVD-101 in people with Delayed Alcohol Induced Headache, run by Cady, Roger, M.D. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Severity 2 Hours Post Treatment (time frame: Immediately Prior to Treatment through 2 Hours Post Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.