Potential Impact (Benefit) of Preventative Treatment With Topamax on the Effectiveness of Axert in the Acute Treatment of Migraine - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 17, 2008

Start Date ^ICMJE

June 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The primary effectiveness parameter will be the proportion of subjects in each treatment group who achieve a Sustained Pain Free (SPF) response during the first qualifying headache of the Assessment Period.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00210496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

For first headache of the Assessment Period, Pain relief at 2 hours; Pain free at 2 hours; Maximum intensity of headache pain; Headache duration; Rescue medication use; Maximum intensity of migraine associated symptoms (photophobia, phonophobia, nausea).

Original Secondary Outcome Measures ^ICMJE

For first headache of the Assessment Period, pain relief at 2 hours, pain free at 2 hours, maximum intensity of headache, headache duration, rescue medication use, and maximum intensity of migraine associated symptoms (photophobia, phonophobia, nausea).

Descriptive Information

Brief Title ^ICMJE

Potential Impact (Benefit) of Preventative Treatment With Topamax on the Effectiveness of Axert in the Acute Treatment of Migraine

Official Title ^ICMJE

Efficacy of AXERT (Almotriptan Malate) in the Acute Treatment of Migraine: A Pilot Study of the Potential Impact of Preventive Therapy With TOPAMAX (Topiramate)

Brief Summary

The purpose of this study is to evaluate the impact of topiramate (migraine prevention medicine) on the effectiveness of almotriptan malate (acute migraine medicine) when treating acute migraine headaches.

Detailed Description

Migraine afflicts greater than 28 million adults in the United States. Acute treatments, such as almotriptan malate, target the symptoms of a migraine attack. Preventive treatments, such as topiramate, primarily target the generation of attacks and may decrease use of acute treatments. Preventive treatments, by a process of neurostabilization, may result in an additive effect on almotriptan malate to improve acute treatment intervention response during a migraine attack. This is a randomized, double blind, parallel group multicenter study that will enroll patients 18-65 years old with a history of 3-12 migraine headaches each month for the past 3 months. The total study duration will be approximately 32 weeks. The study is divided into 4 phases as follows: A Screening Phase that lasts one month; An Open Label Phase where all patients will be treated with topiramate gradually dosed to 100mg a day lasting 6 weeks; A Double Blind Phase lasting 19 weeks at which time patients will be randomized to stay on topiramate 100mg per day or switch to placebo topiramate (50:50 chance) and a Taper/Exit Phase lasting 2 weeks. Almotriptan malate will be used for all migraine headaches during the study as needed. The study hypothesis is that the combination of almotriptan malate and topiramate will have a better clinical response than the combination of almotriptan malate and placebo topiramate. Migraine pain information will be collected from each patient with the use of a Personal Digital Assistant (PDA or Palm Pilot) throughout the study for each migraine attack.

Commercial Topiramate will be gradually increased to 100mg/day in approximately 4-6 weeks. You will then be randomized to either Topiramate or Placebo, dosed at 100mg a day, for the remainder of the study (18 weeks). AXERT 12.5mg may be taken to treat migraine headaches during the study.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Migraine
Common Migraine
Classic Migraine

Intervention ^ICMJE

Drug: topiramate; almotriptan malate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

150

Completion Date

June 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Have a history of migraine headaches for at least 6 months
Experience 3-12 migraines per month
Able to take oral medication
Able to complete the electronic diary (Personal Digital Assistant-PDA)

Exclusion Criteria:

You will not be able to participate in the study if you previously discontinued Topiramate or Almotriptan because it did not make you feel better or it made you feel different
Have 15 or more headache days a month
Experience migraine aura without a headache
Already on a migraine preventative medicine

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00210496

Responsible Party

Study ID Numbers ^ICMJE

CR002875

Study Sponsor ^ICMJE

Janssen-Ortho LLC

Collaborators ^ICMJE

Ortho-McNeil Neurologics, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators ^ICMJE

Study Director:

Janssen Ortho LLC Clinical Trial

Janssen-Ortho LLC

Information Provided By

Janssen-Ortho LLC

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP