Migraine With AuraPhase 2NCT00123201
Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache
A Phase 2 study testing Dronabinol MDI in people with Migraine With Aura and Migraine Without Aura, run by Solvay Pharmaceuticals at 29 sites in United States.
Trial summary
The primary objective of this study is to evaluate the efficacy and safety of dronabinol MDI for the acute treatment of moderate to severe migraine headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine With Aura, Migraine Without Aura
- What is being tested?
- Dronabinol MDI
- How many people
- Not given
- Where
- 29 sitesUnited States
- Study dates
- Sep 2005to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 to 65 years, inclusive, with clinically diagnosed migraine with or without aura based on International Headache Society criteria
Who cannot join
- Subjects who experience migraine with prolonged aura; familiar hemiplegic migraine; migrainous infarction or basilar migraine; and those with greater than eight migraine attacks per month and/or greater than 14 migraine days per month.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Site 21
Alexandria, Virginia
Site 3
Anaheim, California
Site 25
Atlanta, Georgia
Site 2
Boston, Massachusetts
Site 16
Bryan, Texas
Site 12
Chicago, Illinois
Site 1
Chicago, Illinois
Site 29
Clementon, New Jersey
Site 17
Colleyville, Texas
Site 23
Fargo, North Dakota
Site 10
Huntsville, Alabama
Site 8
Huntsville, Alabama
Site 28
Lexington, Kentucky
Site 20
Madisonville, Kentucky
Site 26
Melbourne, Florida
Site 4
Mount Vernon, New York
Site 22
New Port Richey, Florida
Site 19
Omaha, Nebraska
Site 18
Orange City, Florida
Site 27
Pembroke Pines, Florida
Site 14
Plantation, Florida
Site 24
Plantation, Florida
Site 13
Portland, Oregon
Site 9
Raleigh, North Carolina
Site 6
San Francisco, California
Site 5
Spartanburg, South Carolina
Site 7
St. Petersburg, Florida
Site 15
Stockton, California
Site 11
Tucson, Arizona
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Efficacy, Safety and Tolerability Study of Dronabinol MDI in the Acute Treatment of Migraine Headache
The primary objective of this study is to evaluate the efficacy and safety of dronabinol MDI for the acute treatment of moderate to severe migraine headache.
- Conditions
- Migraine With Aura, Migraine Without Aura
- Being tested
- Dronabinol MDI
- Keywords
- efficacy & safety, migraine headache, placebo-controlled, migraine headache with or without aura
- Medical subject headings
- Migraine with Aura, Migraine without Aura, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronabinol MDIDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startSep 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With AuraStudies 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
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123201
- Sponsor's protocol ID
- S175.2.103
- Status last verified
- Sep 2006
- First submitted
- 21 Jul 2005
- Last updated
- 16 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Efficacy, Safety and Tolerability Study of Dronabinol MDI in the Acute Treatment of Migraine Headache
- ClinicalTrials.gov ID
- NCT00123201
- Acronym / sponsor ID
- S175.2.103
- Conditions
- Migraine With Aura, Migraine Without Aura
- Keywords
- efficacy & safety, migraine headache, placebo-controlled, migraine headache with or without aura
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics
- Study start
- Sep 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy and safety of dronabinol MDI for the acute treatment of moderate to severe migraine headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female subjects 18 to 65 years, inclusive, with clinically diagnosed migraine with or without aura based on International Headache Society criteria
Key exclusion criteria (1 listed)
- Subjects who experience migraine with prolonged aura; familiar hemiplegic migraine; migrainous infarction or basilar migraine; and those with greater than eight migraine attacks per month and/or greater than 14 migraine days per month.
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 |
|---|---|---|
| Dronabinol MDI | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
29 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 Dronabinol MDI in people with Migraine With Aura and Migraine Without Aura, run by Solvay Pharmaceuticals at 29 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 1 inclusion and 1 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 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 16 Jan 2015.