Status:
COMPLETED
A Drug Interaction Study of the Pharmacokinetics of Topiramate and FLUNARIZINE When Given Together or Separately
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Jan-Cil Italy
Jan-Cil Spain
Conditions:
Human Volunteers
Migraine
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary purpose of this open-label study is to determine if concomitant therapy with topiramate and flunarizine has any effect on the pharmacokinetics of either drug. Safety will be assessed for a...
Detailed Description
This is a multicenter, randomized open-label study to be conducted in 2 groups of subjects. Group 1 will consist of migraine patients to be recruited at multiple sites and Group 2 will include healthy...
Eligibility Criteria
Inclusion
- Subjects in Group 1 must be diagnosed with migraine for at least 1 year prior to study start. Subjects must also have received any dose of flunarizine for the prophylaxis of migraine, for a minimum of 4 weeks prior to the run-in phase. Subjects in Group 2 must be healthy subjects
- Weight within 15% of the ideal body weight according to height and frame size
- Healthy based on a detailed medical history, physical examination, and clinical laboratory evaluations
- Normal ECG at the time of screening
- Women of non-child bearing potential or practicing acceptable birth control
- Negative pregnancy test within 4 days of run-in phase
- Signed informed consent
Exclusion
- History of significant medical disease (e.g., ophthalmologic, cardiovascular, renal, hepatic, gastrointestinal, hematological, endocrine, metabolic, neurologic or psychiatric disease)
- Conditions known to be contraindications to the use of flunarizine including obesity, hypotension, a history of depressive illness or pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders
- History of an acquired or hereditary neurologic disease, e.g., epilepsy or significant brain trauma
- Subjects who are schizophrenic, exhibit bipolar disorder, or have exhibited any psychotic symptoms or have a history of any serious psychiatric disorder, including suicide attempt
- Subjects demonstrating significant active physical disease, acute or chronic, within 7 days prior to the start of the study
- Active liver disease
- Clinically significant abnormal laboratory tests including, but not limited to, an out-of-range screening TSH level, LFT levels greater than or equal to 2 times above the upper limit of normal, a creatinine level above the upper limit of normal
- Personal or family history of nephrolithiasis
- Allergy to heparin
- History of drug allergy or hypersensitivity to sulfonamides (including RWJ-17021-000, topiramate)
- Malignancy or history of malignancy within the last 5 years with the exception of treated basal cell carcinoma
- Glaucoma
- Testing positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and drugs of abuse, including alcohol
- History of alcohol or drug abuse
- Subjects taking concomitant medications within 14 days prior to Day 1 including iodinated contrast materials that have not been preapproved by the Medical Monitor and Global Clinical Pharmacokinetics Leader
- Subjects who have taken medications that are known cytochrome P450 inducers or inhibitors (see Attachment 4) within the 28 days prior to Day 1
- Subjects who have taken prescription medications within 14 days prior to Day 1 (with the exception of chronic thyroid therapy and rescue/abortive medication for migraine headache) or
- Over-the-counter medications (including aspirin, vitamins) within 7 days prior to Day 1 or antacids within the 48 hours prior to Day 1
- Use tobacco products during the 3 months prior to screening
- Consumption of grapefruit and Seville orange containing products, or herbal medications within the 28 days prior to Day 1
- Drinking alcohol for at least 7 days prior to Day 1
- Subjects who have not limited the consumption of methylxanthine containing products to 2, 8 oz. drinks/day or less within the 24 hours prior to each confinement
- Female subjects who are pregnant and/or nursing
- Subjects who have received an experimental drug, donated blood, or used an experimental medical device within 30 days prior to screening (also subjects who have been recent participants in a topiramate study, within 2 weeks of screening
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00752466
Start Date
March 1 2003
End Date
March 1 2004
Last Update
May 18 2011
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