EUCTR2004-001969-17-GBActive, not recruitingPhase 1
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
Vernalis Development Limited0 sites550 target enrollmentStarted: February 23, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 550
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Patients must be/have:
- •1. Female aged 15 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? yes
- •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
- •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.
Investigators
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