A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK-0974 Co-administered with Ibuprofen or Acetaminophen in Patients with Migraine With or Without Aura

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 628

Inclusion Criteria

1.=18 years of age
2.History of migraine with or without aura > 1 year
3.=1 and =8 migraine days per month in the last 2 months that typically last from 4 to 72 hours untreated.
4.Willing to stay awake for at least 2 hours after administration of study medication

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.> 50 years old at age of migraine onset. Difficulty distinguishing migraine from other headaches
2.Predominantly mild migraine attacks or attacks that usually resolve spontaneously in < 2 hours
3.Basilar or hemiplegic migraine headache.
4.> 15 headache-days/month or has taken medication for acute migraine or other headache on > 10 days/month in last 3 months.
5.Changed dose of prophylactic medication in last 3 months
6.Within 3 months of screening, has had myocardial infarction, unstable angina, coronary artery bypass surgery or other revascularization procedure, stroke, or transient ischemic attack.
7.Uncontrolled hypertension (> 160/100 mm Hg), uncontrolled diabetes, HIV disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease
8.Malignancy = 5 years prior to signing consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or prostate cancer.
9.History of gastric or small intestinal surgery, or disease that causes malabsorption.
10.Hypersensitivity to or previous SAE in response to ibuprofen or acetaminophen.
11.Other confounding pain syndromes (i.e., condition requiring daily use of opioids), psychiatric condition such as major depression based on the criteria such as DSM-IV, dementia or significant neurological disorders other than migraine
12.Any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the patient’s participation for the full duration of the study, or pose an additional undue risk to the patient.
13.Score =2 on item 9 of the PHQ-9
14.Patient has taken any of the following medications in the time frame specified:
Time Frame 1 month prior to screening (and also prohibited throughout the study period)

Therapy
Potent CYP3A4 inhibitors
cyclosporine, itraconazole, ketoconazole,, erythromycin, clarithromycin, telithromycin, nefazodone, HIV protease inhibitorsPotent CYP3A4 inducers
rifampicin, rifabutin, carbamazepine, phenytoin, barbiturates, systemic glucocorticoids, nevirapine, efavirenz, pioglitazone, primidone, St. Johns wort
Specific CYP3A substrates
astemizole, cisapride, pimozide, terfenadine

Concomitant use of other CYP3A4 substrates is permitted with caution (e.g., theophylline, ergot derivatives)
Concomitant use of other CYP3A4 and P-gp substrates is permitted, however, these medications should be administered with appropriate caution due to the potential for drug-drug interaction (e.g. quinidine, theophylline, ergot derivatives).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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