A Drug Interaction Study of the Pharmacokinetics of Topiramate and FLUNARIZINE When Given Together or Separately

NCT00752466 | Completed Phase 1

• 1 other identifier: CR003283
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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 all subjects, for the entire duration of the study.

Conditions

Human Volunteers; Migraine

Keywords

Healthy volunteers; drug interaction; Flunarizine; Topiramate; Migraine

Outcome Measures

Primary Outcomes (1)

• For each treatment and each group, the plasma concentration at each time point and the pharmacokinetic parameters of interest will be summarized using descriptive summary statistics.

Secondary Outcomes (1)

• Incidence and severity of treatment-emergent adverse events and abnormal findings of other safety evaluations. Changes in clinical laboratory test and vital sign results from Baseline to End of Study or early termination will be evaluated.

Interventions

Topiramate; flunarizine DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Jan-Cil Italy: collaborator
• Jan-Cil Spain: collaborator
• Jan-Cil UK: collaborator
• Jan-Cil Switzerland: collaborator

Related Links

• A Drug Interaction Study of the Pharmacokinetics of Flunarizine and Topiramate (RWJ 17021 000) During Mono- and Concomitant Therapy

MeSH Terms

Conditions

Migraine Disorders

Interventions

Topiramate; Flunarizine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 15, 2008
• Study Start: March 1, 2003
• Study Completion: March 1, 2004
• Last Updated: May 18, 2011

Record last verified: 2010-04