A double-blind, placebo-controlled, parallel group study, with an open-label extension phase, to assess the efficacy, tolerability and safety of oral frovatriptan in the prevention of menstrually-related migraine (MRM) headaches in a ‘difficult to treat’ population - MRM02
- Conditions
- Menstrually-Related Migraine (MRM)
- Registration Number
- EUCTR2004-001969-17-DE
- Lead Sponsor
- Vernalis Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 550
Patients must be/have:
1. Female aged 18 years and over, with at least a 12 month documented history of experiencing MRM headache, according to IHS classification
2. Classified as ‘difficult to treat’ (see Section 5.4 and Appendix IX of the protocol)
3. Provided adequate diary data during the run-in phase to confirm diagnosis of MRM headache
4. At least 2 MRM headaches in the previous 3 months
5. Regular predictable menstrual periods
6. MRM headaches occurring between Day –2 and Day +3 of menses
7. Able and willing to sign informed consent and to comply with study procedures, including collection and reporting of diary data
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
Patients must not be/have:
1. More than three migraine attacks per month that are not MRM attacks
2. A history of myocardial infarction, ischemic heart disease (or presenting with symptoms or signs compatible with ischemic heart disease), coronary vasospasm or peripheral vascular disease
3. Significant cerebrovascular disease including basilar or hemiplegic migraine
4. Uncontrolled hypertension SBP > 180 mmHg, DBP > 95 mmHg
5. Severe hepatic or renal insufficiency
6. More than 15 headache days per month
7. Any other condition or serious illness which, in the opinion of the investigator, would interfere with optimal participation in the study
8. A history of clinically relevant allergy, including that to frovatriptan or other triptans
9. Pregnant or breast feeding, or intending to become pregnant or breast-feed during the study period (patients must be using adequate contraception and have a negative pregnancy test at screening)
10. Participated in clinical study VML 251/00/02 (frovatriptan in the prevention of menstrually-related migraine) or VML 251-3MAM03 (open label safety study of frovatriptan in the prevention of menstrually-related migraine.
11. Had treatment with another investigational drug within 30 days or 5 half lives (whichever is longer) before the screening visit
12. Had any change in their oral contraceptive medication (if applicable) in the 2 months prior to screening, or anticipate any change during study participation
13. Had any change in the type or dose of any prophylactic migraine medication in the 2 months prior to screening or anticipate any change during study participation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - The primary objective of the study is to determine whether frovatriptan taken for 6 days, starting 2 days prior to the expected onset of a MRM headache, is effective in the prevention of MRM headaches compared to placebo, in a ‘difficult to treat population’.;Secondary Objective: - To determine the effect of frovatriptan 2.5 mg od and 2.5 mg bd on the incidence, and severity of MRM headaches and associated symptoms over consecutive treated peri-menstrual periods (PMPs). <br><br>- To determine if frovatriptan increases incidence of migraine headaches outside of the treated peri-menstrual period. <br><br>- To evaluate the safety and tolerability of frovatriptan 2.5 mg od and 2.5 mg bd as short-term prophylaxis. <br><br>- To determine the effect of frovatriptan on health related quality of life.;Primary end point(s): Number of MRM headache free PMPs out of a potential of three treated PMPs
- Secondary Outcome Measures
Name Time Method