A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006 AM1)



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:July 2012
End Date:January 2013
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine


The purpose of this study is to assess the effectiveness, safety and tolerability of a range
of doses of MK-1602 versus placebo in the treatment of acute migraine.


Inclusion Criteria:

- > 1 year history of migraine with or without aura as defined by International
Headache Society (IHS) criteria 1.1 and/or 1.2

- Migraines typically last between 4 to 72 hours, if untreated

- ≥ 2 and ≤ 8 moderate or severe migraine attacks per month in each of the two months
prior to screening

- Male, female who is not of reproductive potential, or female of reproductive
potential with a screening serum β-human chorionic gonadotropin (β-hCG) level
consistent with a not-pregnant state, and who agrees to use acceptable contraception

Exclusion Criteria:

- Pregnant or breast-feeding, or is a female expecting to conceive within the projected
duration of study participation

- Participant has difficulty distinguishing his/her migraine attacks from tension-type
headaches

- History of predominantly mild migraine attacks or migraines that usually resolve
spontaneously in less than two hours

- More than 15 headache-days per month or has taken medication for acute headache on
more than 10 days per month in any of the three months prior to screening

- Basilar-type or hemiplegic migraine headache

- > 50 years old at age of migraine onset

- Taking migraine prophylactic medication where the prescribed daily dose has changed
during the 3 months prior to screening and will not be changed during the study

- Taking a proton pump inhibitor (PPI) or a histamine receptor 2 (H2) blocker on a
daily or near daily basis (> 3 days per week)

- Taking the following medications from 1 month prior to screening through study
period: potent cytochrome P450 (CYP) 3A4 inhibitors (e.g., cyclosporine,
itraconazole, ketoconazole, fluconazole, erythromycin, clarithromycin, nefazodone,
telithromycin, cimetidine, quinine, diltiazem, verapamil, and human immunodeficiency
virus [HIV] protease inhibitors), moderate or marked CYP3A4 inducers (e.g.,
rifampicin, rifabutin, barbiturates [e.g., phenobarbital and primidone], systemic
glucocorticoids, nevirapine, efavirenz, pioglitazone, carbamazepine, phenytoin, and
St. Johns wort), or drugs with narrow therapeutic margins and potential for drug
interactions in the CYP2C family (e.g., warfarin)

- Participant is unable to refrain from consumption of grapefruit or grapefruit juice
during study

- History of hypersensitivity to, or has experienced a serious adverse event in
response to 3 or more classes of drugs (prescription and over-the-counter)

- Clinical or laboratory evidence of uncontrolled diabetes, human immunodeficiency
virus (HIV) disease, or significant pulmonary, renal, hepatic, endocrine, or other
systemic disease

- Other confounding pain syndromes, psychiatric conditions such as uncontrolled major
depression, dementia or significant neurological disorders other than migraine.
Patients who are currently being treated with non-prohibited medication for
depression and symptoms are well controlled are eligible to participate

- Participant is at imminent risk of self-harm

- History of malignancy ≤ 5 years prior to study, except for adequately treated basal
cell or squamous cell skin cancer, or in situ cervical cancer

- History of gastric or small intestinal surgery (including gastric bypass surgery or
banding), or presence of a disease that causes malabsorption

- Participant has recent history (within the last year) of drug or alcohol abuse or
dependence or is a user of recreational or illicit drugs

- Participant is legally or mentally incapacitated

- Donation of blood products or phlebotomy of > 300 ml within 8 weeks of study, or
intent to donate blood products or receive blood products within 30 days of screening
and throughout study

- Intent to donate eggs or sperm within the projected duration of the study

- Current participation in or participation within 30 days of screening in a study with
an investigational compound or device

- Previous exposure to MK-0974 and/or MK-3207

- Use within the past 2 months of an opioid- or barbiturate-containing analgesic for
migraine relief

- Inpatient or emergency department treatment of an acute migraine attack within the
past 2 months
We found this trial at
52
sites
636
mi
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Watertown, MA
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167
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Ann Arbor, MI
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344
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Baltimore, MD
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655
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Bentonville, AZ
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1655
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Chandler, AZ
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362
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Chattanooga, TN
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274
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Chicago, IL
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98
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Cincinnati, OH
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98
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Cincinnati, OH
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995
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Coral Gables, FL
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1174
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Corpus Christi, TX
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457
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Edison, NJ
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393
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Endwell, NY
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1958
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Fullerton, CA
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Greensboro, North Carolina 27405
321
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Greensboro, NC
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989
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Hialeah, FL
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666
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Hot Springs, AR
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991
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Houston, TX
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991
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Houston, TX
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673
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Jacksonville, FL
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237
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Kingsport, TN
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1942
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La Mesa, CA
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1032
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Lake Jackson, TX
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636
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Lexington, MA
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188
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Louisville, KY
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134
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Lyndhurst, OH
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802
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Marrero, LA
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996
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Miami, FL
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617
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Milford, MA
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625
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Minneapolis, MN
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North Dartmouth, Massachusetts 02747
639
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North Dartmouth, MA
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850
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Oklahoma City, OK
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767
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Orange City, FL
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796
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Orlando, FL
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745
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Ormond Beach, FL
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Palm Beach Gardens, Florida 33418
922
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Palm Beach Gardens, FL
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Philadelphia, Pennsylvania 19114
416
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Philadelphia, PA
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1662
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Phoenix, AZ
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1654
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Phoenix, AZ
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162
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Pittsburgh, PA
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2028
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Portland, OR
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Redondo Beach, California 90277
1985
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Redondo Beach, CA
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1137
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San Antonio, TX
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1947
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San Diego, CA
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1985
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Santa Monica, CA
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407
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St. Louis, MO
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179
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Troy, MI
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1958
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Tustin, CA
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174
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Uniontown, PA
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615
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Warwick, RI
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85
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West Chester, OH
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Winston-Salem, North Carolina 27103
307
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Winston-Salem, NC
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