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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 April 2019 |
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Main ID: |
EUCTR2008-008283-26-ES |
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Date of registration:
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20/01/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Ensayo multicéntrico cruzado, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la tolerabilidad de rizatriptán 10 mg CBD en el tratamiento de la migraña aguda en pacientes que siguen un tratamiento profiláctico de la migraña con topiramato.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg ODT for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
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Scientific title:
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Ensayo multicéntrico cruzado, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la tolerabilidad de rizatriptán 10 mg CBD en el tratamiento de la migraña aguda en pacientes que siguen un tratamiento profiláctico de la migraña con topiramato.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg ODT for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
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Date of first enrolment:
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03/04/2009 |
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Target sample size:
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100 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-008283-26 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Italy
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Male or female at least 18 years of age.
Patient has a history of migraine with or without aura > 1 year with ?2 and ?8 moderate or severe migraine attacks per month in the 3 months prior to screening.
Patient is currently taking topiratmate for migraine prophylaxis, at a minimum daily dose of 50 mg and where the prescribed dose has been stable for at least 3 months.
Female patients of reproductive potential must agree to use acceptable method of birth control.
Patient understands study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
Patient is able to complete the study questionnaire(s) and paper diaries.
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:
Patient is pregnant, or breast-feeding, or is a female expecting to conceive within the projected duration of the study.
Patient has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.
Patient was > 50 years old at age of migraine onset.
Aside from topiramate, patient is taking more than one other medication for migraine prophylaxis.
Patient has a history or clinical evidence of cerebrovascular accident (CVA) or transient ischemic attack (TIA), ischemic heart disease, or other significant underlying cardiovascular disease or peripheral vascular disease.
Patient has uncontrolled hypertension as determined by the investigator.
Patient is taking or has been newly prescribed selective serotonin reuptake inhibitors (SSRI) or serotonin norepinephrine reuptake inhibitors (SNRI) where the prescribed daily dose has changed during the 3 months prior to screening.
Patient is taking other migraine prophylactic medication where the prescribed daily dose has changed during the 3 months prior to screening.
Patient has either demonstrated a hypersensitivity reaction, anaphylaxis or anaphylactoid reaction to or experienced a serious adverse event in response to rizatriptan.
Patient has a history of hypersensitivity to more than two chemical classes of drugs, including prescriptions and over-the-counter medications.
Patient has taken any of the following medications in the time frame specified: (1) Non-steroidal anti-inflammatory drugs (NSAIDS), COX-2 inhibitors, or other analgesics daily or nearly daily (typically >3 days out of 7 days average); (2) Monoamine oxidase inhibitors (MAOIs) or Propranolol within 1 month prior to screening and during the study. (Note: Aspirin ? 325 mg daily is allowed for cardioprotection.)
Patient has a history of neoplastic disease ?5 years.
Patient is legally or mentally incapacitated.
Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening.
Patient has a history (within the past 1 year) or current evidence of drug or alcohol abuse or is a 'recreational user' of illicit drugs or prescription medications.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Acute migraine
Migraña Aguda
MedDRA version: 9.1
Level: LLT
Classification code 10066635
Term: Acute migraine
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Intervention(s)
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Trade Name: MAXALT MAX 10 mg liofilizado oral
Product Name: Maxalt
Pharmaceutical Form: Tablet
INN or Proposed INN: RIZATRIPTAN BENZOATO
Other descriptive name: RIZATRIPTAN BENZOATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: To evaluate the efficacy of MK-0462 compared to placebo in the treatment of acute migraine in patients on topiramate for migraine prophylaxis, as measured by the proportion of treated attacks resulting in pain relief (PR) at 2 hours post-dose.
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Secondary Objective: To evaluate the efficacy of rizatriptan compared to placebo in the treatment of acute migraine in patients on topiramate for migraine prophylaxis as measured by: (1) Sustained pain relief (SPR) from 2-24 hours post dose; (2) pain freedom (PF) at 2 hours post-dose; (3) Functional disability at 2 hours post-dose; (4) Patient satisfaction with treatment at 24 hours post-dose.
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Primary end point(s): Efficacy: Pain relief (PR) at 2 hours post-dose, with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade1/0.
Safety: Safety and tolerability will be assessed by review of all safety parameters, including adverse experiences and vital signs.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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