Migraine DisordersPhase 3FREEDOM301NCT00623636

Phase 3 Study of MAP0004 in Adult Migraineurs

A Phase 3 study testing MAP0004 in people with Migraine Disorders, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in adult migraineurs. Subjects will self administer study drug in the outpatient setting. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Migraine Disorders
What is being tested?: MAP0004
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 902 participants
Where: 1 siteUnited States
Study dates: Jul 2008to Jan 2011
Phase: Phase 3
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Major Inclusion Criteria:

Male or female between 18 and 65 years of age.
History of episodic, acute migraine (with or without aura) with onset prior to 50

Major Exclusion Criteria:

Known allergy or sensitivity or contraindication to study drugs or their formulations
History of chronic pulmonary disease, coronary artery disease (CAD), liver disease, kidney disease, seizures, stroke, or major psychiatric condition.
Any condition that, in the opinion of the Investigator, would make the subject unsuitable for study participation

Trial locations and contacts

1 site in 1 country.

United States1 site

Swedish Pain and Headache Clinic
Seattle, Washington, 98104

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of MAP0004 in Adult Migraineurs for a Single Migraine Followed by Open Label Extension.

This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in adult migraineurs. Subjects will self administer study drug in the outpatient setting.

Conditions: Migraine Disorders
Being tested: MAP0004, Placebo
Keywords: Migraine
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MAP0004Drug
MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only.
PlaceboDrug
Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.

Study groups in NCT00623636
Study group	Role	What they receive
MAP0004	Experimental	MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Receives: Drug: MAP0004
Placebo	Other	Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks. Receives: Drug: MAP0004; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Pain Relief at 2 Hours From Time of First Dose
Pain relief at 2 hours was defined as change in rating from severe or moderate (score 3 or 2) to a rating of none or mild (score 0 or 1) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Measured: 2 hours from time of first dose
Number of Subjects Photophobia Free at 2 Hours From Time of First Dose
Photophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Measured: 2 hours from time of first dose
Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose
Phonophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Measured: 2 hours from time of first dose
Number of Subjects Nausea Free at 2 Hours From Time of First Dose
Nausea free was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours post-dose.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Measured: 2 hours from time of first dose

Secondary outcomes (4)

Number of Subjects With Sustained Pain Relief From 2 to 24 Hours
Sustained Pain Relief was defined as a rating of none or mild (score 0 or 1) at the 2-hour time point that was maintained during the 2-24 hour post-dose period and no use of rescue medication from the time of first dose to 24 hours.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Measured: From 2 to 24 hours from time of first dose
Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours
The number of subjects who reported pain relief (score of 0 or 1) at any time within the 2 hours following the time of first dose and who did not use rescue medication on or prior to this point. Subjects who did not reach pain relief by the end of the time period were not included.
The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Measured: 2 hours from the first dose
Number of Subjects With Pain Relief at 4 Hours
Pain Relief at 4 hours was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 4-hour time point and no use of rescue medication from the time of first dose to 4 hours.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Measured: 4 hours from time of first dose
Number of Subjects With Pain Relief at 10 Minutes
Pain Relief at 10 minutes was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 10 minute time point and no use of rescue medication from the time of first dose to 2 hours.
The 4-point scale from the International Headache Society was used:
0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Measured: 2 hours from time of first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Jan 2011

First posted26 Feb 2008 (estimated)
Study startJul 2008
Primary completionDec 2010
Study completionJan 2011

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Migraine DisordersStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 902 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00623636
Sponsor's protocol ID: MAP0004 CL P301
Acronym: FREEDOM301
Status last verified: Dec 2013
First submitted: 7 Feb 2008
Last updated: 9 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Tepper SJ, Kori SH, Borland SW, Wang MH, Hu B, Mathew NT, Silberstein SD. Efficacy and safety of MAP0004, orally inhaled DHE in treating migraines with and without allodynia. Headache. 2012 Jan;52(1):37-47. doi: 10.1111/j.1526-4610.2011.02041.x. Epub 2011 Nov 22.
PubMed 22106843
Tepper SJ, Kori SH, Goadsby PJ, Winner PK, Wang MH, Silberstein SD, Cutrer FM. MAP0004, orally inhaled dihydroergotamine for acute treatment of migraine: efficacy of early and late treatments. Mayo Clin Proc. 2011 Oct;86(10):948-55. doi: 10.4065/mcp.2011.0093.
PubMed 21964172
Aurora SK, Silberstein SD, Kori SH, Tepper SJ, Borland SW, Wang M, Dodick DW. MAP0004, orally inhaled DHE: a randomized, controlled study in the acute treatment of migraine. Headache. 2011 Apr;51(4):507-17. doi: 10.1111/j.1526-4610.2011.01869.x.
PubMed 21457235

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of the Glymphatic System in Migraine
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Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
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A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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All Migraine Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of MAP0004 in Adult Migraineurs for a Single Migraine Followed by Open Label Extension.
ClinicalTrials.gov ID: NCT00623636
Acronym / sponsor ID: FREEDOM301 / MAP0004 CL P301
Conditions: Migraine Disorders
Keywords: Migraine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 902 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Collaborators: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Study start: Jul 2008
Primary completion: Dec 2010 (actual)
Study completion: Jan 2011 (actual)
First posted: 26 Feb 2008 (estimated)
Results: Posted 29 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in adult migraineurs. Subjects will self administer study drug in the outpatient setting.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MAP0004	Experimental	Drug: MAP0004MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
Placebo	Other	Drug: MAP0004, Drug: PlaceboPlacebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
MAP0004MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only.	Drug	MAP0004, Placebo
PlaceboPlacebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.	Drug	Placebo

Primary outcome

Number of Subjects With Pain Relief at 2 Hours From Time of First Dose
Time frame: 2 hours from time of first dose
Pain relief at 2 hours was defined as change in rating from severe or moderate (score 3 or 2) to a rating of none or mild (score 0 or 1) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Number of Subjects Photophobia Free at 2 Hours From Time of First Dose
Time frame: 2 hours from time of first dose
Photophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose
Time frame: 2 hours from time of first dose
Phonophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Number of Subjects Nausea Free at 2 Hours From Time of First Dose
Time frame: 2 hours from time of first dose
Nausea free was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours post-dose. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities

4 secondary outcomes

Number of Subjects With Sustained Pain Relief From 2 to 24 Hours
Time frame: From 2 to 24 hours from time of first dose
Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours
Time frame: 2 hours from the first dose
Number of Subjects With Pain Relief at 4 Hours
Time frame: 4 hours from time of first dose
Number of Subjects With Pain Relief at 10 Minutes
Time frame: 2 hours from time of first dose

Results and safety

Results posted to the registry on 29 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	452	419
MAP0004	450	422

Primary outcome: Number of Subjects With Pain Relief at 2 Hours From Time of First Dose

Time frame: 2 hours from time of first dose. Number. Unit: participants

Measure	Placebo n = 397	MAP0004 n = 397
Value	136	231

Population analysed: mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.

Primary outcome: Number of Subjects Photophobia Free at 2 Hours From Time of First Dose

Time frame: 2 hours from time of first dose. Number. Unit: participants

Measure	Placebo n = 397	MAP0004 n = 397
Value	107	182

Primary outcome: Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose

Time frame: 2 hours from time of first dose. Number. Unit: participants

Measure	Placebo n = 397	MAP0004 n = 397
Value	133	208

Primary outcome: Number of Subjects Nausea Free at 2 Hours From Time of First Dose

Time frame: 2 hours from time of first dose. Number. Unit: participants

Measure	Placebo n = 397	MAP0004 n = 397
Value	234	266

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double-blind Placebo	0 of 404 (0%)	60 of 404 (14.9%)	Not reported
Double-blind MAP0004	0 of 410 (0%)	86 of 410 (21%)	Not reported
Open-label MAP0004	14 of 638 (2.2%)	454 of 638 (71.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22106843Tepper SJ, Kori SH, Borland SW, Wang MH, Hu B, Mathew NT, Silberstein SD. Efficacy and safety of MAP0004, orally inhaled DHE in treating migraines with and without allodynia. Headache. 2012 Jan;52(1):37-47. doi: 10.1111/j.1526-4610.2011.02041.x. Epub 2011 Nov 22.
Derived from this study: PubMed 21964172Tepper SJ, Kori SH, Goadsby PJ, Winner PK, Wang MH, Silberstein SD, Cutrer FM. MAP0004, orally inhaled dihydroergotamine for acute treatment of migraine: efficacy of early and late treatments. Mayo Clin Proc. 2011 Oct;86(10):948-55. doi: 10.4065/mcp.2011.0093.
Derived from this study: PubMed 21457235Aurora SK, Silberstein SD, Kori SH, Tepper SJ, Borland SW, Wang M, Dodick DW. MAP0004, orally inhaled DHE: a randomized, controlled study in the acute treatment of migraine. Headache. 2011 Apr;51(4):507-17. doi: 10.1111/j.1526-4610.2011.01869.x.

Related trials for Migraine Disorders

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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.

Medical Director study director

MAP Pharmaceuticals a Wholly Owned Subsidiary of Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MAP0004 in people with Migraine Disorders, run by Allergan at 1 site 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?

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 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 29 Oct 2013). 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?

Number of Subjects With Pain Relief at 2 Hours From Time of First Dose (time frame: 2 hours from time of first dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00623636, which also lists 3 linked publications.

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 9 Jan 2014.