A Worldwide, Open Label, Clinical Trial to Examine the Long Term Safety and Tolerability of Rizatriptan in Pediatric Migraineurs for the Treatment of Migraine With or Without Aura
- Conditions
- ong term treatment of acute migraine, with or without aura, in children and adolescents, ages 12 to 17 years.MedDRA version: 12.0Level: LLTClassification code 10066635Term: Acute migraine
- Registration Number
- EUCTR2009-016375-30-GB
- Lead Sponsor
- Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 630
1. Patient is between 12 and 17 years of age at screening visit 1, inclusive.
2. Patient weighs = 20 kg (44 pounds).
3. Patient is either:
a. of reproductive potential and agrees to maintain true abstinence* or use (or have
their partner use) one of the listed highly effective methods of birth control within
the projected duration of the study: hormonal contraceptives, intrauterine device
(IUD), condoms, diaphragm, and/or 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 protocol Section 3.2.3.2.
OR
b. not of reproductive potential. For the purposes of this protocol, the following
definitions apply:
A female patient who is not of reproductive potential is defined as:
one who 1) has not reached menarche, or 2) is 6 weeks post surgical bilateral
oophorectomy, hysterectomy, or bilateral tubal ligation.
A male patient who is not of reproductive potential is defined as:
one who has undergone a successful vasectomy. A successful vasectomy is
defined as: 1) microscopic documentation of azoospermia, or 2) a vasectomy
more than 2 years ago with no resultant pregnancy despite sexual activity post
vasectomy.
* If abstinence is not a locally acceptable method of contraception, then another highly effective birth control method must be used.
4. Patient has a history of migraine defined by International Headache Society [IHS]
migraine definitions, and meets the following criteria:
a. Unilateral or bilateral migraine headache, with or without aura;
b. History of migraine attacks for > 6 months; and
c. Reports = 1 to = 8 mild, moderate or severe migraine attacks per month in the
2 months prior to screening Visit 1.
5. Patient is able to complete the migraine diary and is cooperative with completing the prestudy assessments. Patients who require help to read should be assisted by an adult; however, the patient will provide the actual responses to the pain scale
questions in the migraine diary.
6. The parent or guardian and patient agree to the patient’s participation in the study as indicated by parental/guardian signature on the consent form and patient assent.
7. For patients taking migraine prophylactic medication, treatment regimen has been
stable for at least 3 months prior to Visit 1.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 ß-hCG test at screening) or breast-feeding, or is a female expecting to conceive within the projected duration of study participation.
2. Patient has a history of predominantly mild migraine attacks or migraines usually
resolved spontaneously in less than 2 hours.
3. Patient has basilar or hemiplegic migraine headaches (see Appendix 6.2 for
diagnostic guidance for basilar type migraines).
4. Patient has >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.
5. Patient has clinical, laboratory, or ECG evidence of uncontrolled hypertension,
uncontrolled diabetes, HIV disease, any neoplastic disease, or other significant
pulmonary, renal, hepatic, endocrine, neurological, or other systemic disease in the
opinion of the investigator (e.g., epilepsy; systemic lupus erythematosus; Kawasaki
disease; homozygous sickle cell anemia; recurrent syncope).
6. Patient has a history or clinical evidence of any of the following: congenital heart
disease suspected or confirmed; atherosclerotic disease; history of cerebrovascular
pathology including stroke; Prinzmetal’s angina; cardiac arrhythmias requiring
medication; and hypertension for age.
7. Patient has a history or current evidence of any clinically significant disease that,
according to the investigator, might confound the results of the study [e.g., chronic
pain syndromes (i.e., condition requiring daily use of opiates), major psychiatric
diagnoses such as schizophrenia, bipolar disorder, or major depression], that
complicate the interpretation of the study results, that might interfere with the
patient’s participation for the full duration of the study, or pose an additional undue
risk to the patient.
8. Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan.
9. Patient has demonstrated hypersensitivity to or experienced a serious adverse event in response to 3 or more pharmacologic classes of drugs (prescription and over-thecounter).
10. Patient did not experience satisfactory relief from migraine pain with treatment of 2 or more adequate courses of 5HT1 agonists, in the opinion of the investigator.
11. Patient has a recent history (within the past year) or current evidence of drug or
alcohol abuse or is a recreational user of illicit drugs.
12. Patient is currently taking monoamine oxidase inhibitors, methysergide, or
propranolol, and is unable to tolerate withdrawal of these medications for the
intervals required.
13. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening. (This includes studies using commercially available compounds or devices for investigational purposes, e.g., new indications). Note: Patients who participated in the acute efficacy study (rizatriptan Protocol 082) may enter into this study within 30 days of completion of the acute study.
14. Patient has abnormal screening laboratory values as per the guidelines listed below or other clinically significant, unexplained laboratory abnormality, according to the investigator:
a. AST > 1.5 x upper limit of normal
b. ALT > 1.5 x upper limit of normal
c. Total bilirubin > 1.5 x upper limit of normal
d. Serum creatinine > 1.5 x upper limit of normal
15. Patient is legally or mentally incapacitated.
16. Patient has undergone major surgery (in t
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of rizatriptan in the long term treatment of<br>acute migraine in pediatric patients age 12-17 years.;Secondary Objective: To estimate the efficacy of rizatriptan as measured by pain freedom at 2 hours post<br>dose in the long term treatment of acute migraine in pediatric patients age 12-17<br>years.;Primary end point(s): The main efficacy endpoint is pain freedom at 2 hours postdose.<br>
- Secondary Outcome Measures
Name Time Method