Migraine MedDRA version: 12.1 Level: LLT Classification code 10027599 Term: Migraine
Conditions
Interventions
Product Name: MK-0974
Product Code: MK-0974
Pharmaceutical Form: Film-coated tablet
Other descriptive name: Telcagepant
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Merck Sharp & Dohme Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is/has: 1. = 18 years of age at screening. 2. female who has had regular menstrual cycles monthly (22 to 32 days) for at least the last 3 cycles. 3. a history of migraine with or without aura for = 3 months and with = 2 migraine attacks per month in the 2 months prior to screening (see Appendix 6.1 and ICHD II Attachment for IHS migraine definitions). 4. headache during menstrual period in at least 2 out of last 3 cycles. Note: headache during menstrual period may occur within -2 days of menses onset to +3 days of menses cessation. 5. agrees to use (or have their partner use) a highly effective method of birth control within the projected duration of the study. Complete details regarding contraceptive requirements are specified in protocol Section 3.2.2.3. 6. understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. 7. able to complete the paper patient headache diary. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient is/has: 1. basilar or hemiplegic migraine headache. 2. taken medication for acute headache attack on more than 15 days per month in any of the 3 months prior to screening. 3. taking migraine prophylactic medication where the prescribed daily dose has changed during the 4 weeks prior to screening. 4. pregnant (positive pregnancy test at pre-study), breast-feeding, or expecting to conceive within the projected duration of the study. 5. clinical or laboratory evidence of uncontrolled hypertension (defined as SBP of = 160 mm Hg and/or DBP of = 100 mm Hg), uncontrolled diabetes, HIV disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the investigator. 6. myocardial infarction, unstable angina, coronary artery bypass surgery, or other revascularization procedure, stroke, or transient ischemic attack within 3 months of screening. 7. other confounding pain syndromes (i.e., condition requiring daily use of opioids), psychiatric conditions such as uncontrolled major depression based on criteria such as DSM-IV, dementia or significant neurological disorders other than migraine. 8. history of neoplastic disease = 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. 9. history of gastric or small intestinal surgery (including gastric bypass surgery or banding), or has a disease that causes malabsorption. 10. history or current evidence of any clinically significant disease that according to the investigator 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. 11. history of AST or ALT = 5 x upper limit of normal. 12. history of Gilbert’s syndrome, infectious hepatitis, or other significant hepatic disease in the opinion of the investigator. (e.g. any chronic hepatitis, cirrhosis, autoimmune hepatitis, primary sclerosing cholangitis, non-alcoholic steatohepatitis, or hereditary liver disease). 13. abnormal screening laboratory values as per the guidelines listed below or other clinically significant, unexplained laboratory abnormality according to the investigator. - AST >1.5 x upper limit of normal - ALT > 1.5 x upper limit of normal - Total bilirubin >1.5 x upper limit of normal - Serum creatinine >2.0 x upper limit of normal 14. has taken any of the following systemic medications (oral/IV) in the time frame specified: Therapy Time Frame Potent CYP3A4 inhibitors, including but not limited to: cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, nefazodone, HIV protease inhibitors Potent CYP3A4 inducers, including but not limited to: rifampicin, rifabutin, carbamazepine, phenytoin, barbiturates (low-dose barbiturates permitted), systemic glucocorticoids (replacements and inhaled are permitted), nevirapine, efavirenz, pioglitazone, primidone Divalproex, Valproic acid 1 mo. prior to screening and throughout the study period 15. history of hypersensitivity to more than two chemical classes of drugs, including prescription and over-the-counter medications. 16. history (within the past 1 year) of drug or alcohol abuse. 17. consumes 3 or more alcoholic drinks per day. Note: 1 drink = 12 oz. can/bottle of beer or 4 oz. of wine, or 1 oz. of liquor. 18. legally or mentally incapacitated. 19. donated blood produc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Mean monthly headache days while on drug.;Main Objective: 1. To evaluate the efficacy of telcagepant 140 mg once daily for 7-days per month compared to placebo for the prevention of migraine during the study period in female patients with menstually related migraine or pure menstrual migraine. 2. To examine the tolerability and safety of telcagepant 140 mg once daily for 7-days per month for the prevention of migraine in female patients with episodic migraine. ;Secondary Objective: 1. To evaluate the efficacy of telcagepant 140 mg once daily for 7-days per month compared to placebo, for the prevention of migraine in female patients with menstrually related migraine. 2.To evaluate the efficacy of telcagepant 140 mg once daily for 7-days per month compared to placebo for the prevention of migraine while on drug in female patients with mentrually related migraine of pure mentsrual migraine. 3.To evaluate the efficacy of telcagepant 140 mg once daily for 7-days per month compared to placebo for the prevention of migraine while on drug in female patients with menstrually related migraine. 4. To evaluate the efficacy of telcagepant 140 mg once daily for 7-days per month compared to placebo for the preventive treatment of migraine while on drug in female patients with pure menstrual migraine. | — |
Countries
Denmark, Finland, Germany, Netherlands, Sweden, United Kingdom
Outcome results
None listed