A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Dose-Finding Study of MK-3207 in the Treatment of Acute Migraine. - ND
- Conditions
- Patient has greater than a 1 year history of migraine with or without aura.MedDRA version: 9.1Level: LLTClassification code 10009236Term: Classical migraine
- Registration Number
- EUCTR2008-001226-14-IT
- Lead Sponsor
- MERCK & CO., INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 685
1. Patient is ≥ 18 and ≤ 65 years of age at screening (Visit 1).
2. Patient has greater than a 1 year history of migraine with or without aura as defined
by IHS criteria 1.1 and/or 1.2 whose migraines typically last between 4 to 72 hours, if
untreated (Refer to Appendix 6.1 and ICHD II Attachment for IHS migraine
definitions).
3. Patient has had ≥ 2 and ≤ 8 moderate or severe migraine attacks per month in the 2
months prior to screening (Visit 1).
4. Patient is either a male or:a. a female of reproductive potential and agrees to maintain true abstinence* or use
(or have their partner use) two of the listed highly effective methods of birth
control within the projected duration of the study: hormonal contraceptives?,
intrauterine device (IUD), condoms, diaphragm, vasectomy. The use of barrier
contraceptive (condom or diaphragm) should always be supplemented with the
use of a spermicide. Complete details regarding contraceptive requirements are
specified in Section 3.2.2.3.
OR
b. a female who is not of reproductive potential defined as:
one who has either (1) reached natural menopause (defined as at least 46 years
old with (a) 12 months spontaneous amenorrhea or (b) 6 months of
spontaneous amenorrhea with serum FSH levels in the postmenopausal range
as determined by the central laboratory), (2) 6 weeks post surgical bilateral
oophorectomy, (3) hysterectomy, or (4) bilateral tubal ligation.
* If abstinence is not a locally acceptable method of contraception, then two
highly effective birth control methods must be used.
? Patients taking hormonal contraceptives may continue use during the trial, but
must use 2 additional forms of non-hormonal contraception throughout the study
period until data regarding potential interaction of MK-3207 with oral
contraceptives are available. Patients who have been using hormonal
contraceptives for at least 2 months prior to the trial must agree to use 2 additional
forms of non-hormonal contraception from the time of signing informed consent
up to 2 weeks post treatment.
5. Patient understands the study procedures, alternative treatments available, and risks
involved with the study and voluntarily agrees to participate in the study by giving
written informed consent.
6. Patient is able to read, understand and complete the study questionnaires, paper diary,
and access the Interactive Voice Response System (IVRS) 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
1. Patient is pregnant (positive serum β-hCG test at pre-study) or breast-feeding, or is a
female expecting to conceive within the projected duration of the study.
2. Patient has difficulty distinguishing his/her migraine attacks from tension-type
headaches.
3. Patient has a history of predominantly mild migraine attacks or migraines that usually
resolve spontaneously in less than 2 hours.
4. Patient has 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 3 months prior to screening
(Visit 1).
5. Patient has basilar-type or hemiplegic migraine headache.
6. Patient was > 50 years old at age of migraine onset.
7. Patient is taking migraine prophylactic medication where the prescribed daily dose
has changed during the 3 months prior to screening (Visit 1).
8. Patient is taking a proton pump inhibitor (PPI) or a H2 blocker on a daily or near
daily basis (> 3 days per week).
9. Patient has taken any of the following medications in the time frame specified
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To assess dose response of 2-hour pain freedom (PF) post dose across a range of<br>MK-3207 doses.<br>2. To assess the effectiveness of MK-3207 in the treatment of acute migraine as<br>measured by 2-hour PF post dose.<br>3. To evaluate the safety and tolerability of various doses of MK-3207 in the treatment<br>of acute migraine.;Secondary Objective: To assess the effectiveness of MK-3207 in the treatment of acute migraine as<br>measured by pain relief at 2 hours post dose.;Primary end point(s): The primary efficacy endpoint is the proportion of patients reporting pain freedom from headache (Grade 0) at 2 hours after treatment.
- Secondary Outcome Measures
Name Time Method