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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210496
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 17, 2011
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Janssen-Ortho LLC

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.

Condition or disease Intervention/treatment Phase
Migraine Classic Migraine Common Migraine Drug: topiramate; almotriptan malate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of AXERT (Almotriptan Malate) in the Acute Treatment of Migraine: A Pilot Study of the Potential Impact of Preventive Therapy With TOPAMAX (Topiramate)
Study Start Date : June 2005
Actual Study Completion Date : June 2007

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210496

Sponsors and Collaborators
Janssen-Ortho LLC
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Study Director: Janssen Ortho LLC Clinical Trial Janssen-Ortho LLC
Additional Information:
Layout table for additonal information Identifier: NCT00210496    
Other Study ID Numbers: CR002875
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: April 2010
Keywords provided by Janssen-Ortho LLC:
Migraine headache
Topiramate, Almotriptan malate
Additional relevant MeSH terms:
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Migraine Disorders
Migraine with Aura
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action