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Human VolunteersPhase 1NCT00752466

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

A Phase 1 study testing Topiramate; flunarizine in people with Human Volunteers and Migraine, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Human Volunteers, Migraine
What is being tested?
Topiramate; flunarizine
How many people
75 participants
Where
No sites listed yet
Study dates
Mar 2003to Mar 2004
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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

About this study

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

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.

Read the 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 subjects at a single study center. In Group 1 a total of 36 subjects will be enrolled with a target of having 24 subjects complete the study. In Group 2, a total of 28 healthy subjects will be enrolled so that at least 24 will complete the trial. Group 1 will include patients under treatment for migraine prophylaxis with any dose of flunarizine for at least 4 weeks prior to the 6-week run-in phase. Once selected, patients will enter a 6-week run-in phase in which they will receive 5mg of flunarizine every evening. Following this run-in phase, patients will continue on flunarizine and be randomized into 2 subgroups of equal size; Subgroup 1a will consist of patients being treated with topiramate and flunarizine and Subgroup 1b, the control group, where patients will only be receiving flunarizine treatment. Patients in Group 1 (Subgroups 1a and 1b) will commence initial confinement (Day 1) after completing the 6-week run-in phase. All these patients must have a history of migraine according to IHS1 criteria for at least 1 year prior to study entry. For both Groups 1 and 2 dropouts will be replaced to ensure the required number of patients/subjects of each sex to complete the study. Safety will be assessed by studying the 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.

In Group 1: 5 mg flunarizine every 24 hours (at 8:00 p.m.), beginning on Day -42 for 6 weeks, through Day -1. Patients will continue to receive this dose from Days 1 through 81. Group 1a: On Day 4 Topiramate dose titrated from 25 mg BID to 75 mg (25 mg am and 50 mg pm) by Day 19 and 50 mg BID by Day 26 - Day 81. Group 1b continue on Flunarizine only. Group 2: Topiramate beginning Day 2 titration from 25 mg BID to 50 mg BID by Day 5 through 18. 5mg Flunarizine daily starting Day 12- Day 18.

Being tested
Topiramate; flunarizine
Keywords
Healthy volunteers, drug interaction, Flunarizine, Topiramate, Migraine
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Topiramate; flunarizineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2008 (estimated)
  2. Study startMar 2003
  3. Study completionMar 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00752466
Sponsor's protocol ID
CR003283
Status last verified
Apr 2010
First submitted
11 Sep 2008
Last updated
18 May 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Topiramate; flunarizine in people with Human Volunteers and Migraine, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00752466.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2011.

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