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

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Janssen-Ortho LLC
ClinicalTrials.gov Identifier:
NCT00210496
First received: September 13, 2005
Last updated: May 16, 2011
Last verified: April 2010
  Purpose

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 Intervention Phase
Migraine
Classic Migraine
Common Migraine
Drug: topiramate; almotriptan malate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Janssen-Ortho LLC:

Primary Outcome Measures:
  • 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:
  • 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).

Enrollment: 406
Study Start Date: June 2005
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210496

Sponsors and Collaborators
Janssen-Ortho LLC
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Janssen Ortho LLC Clinical Trial Janssen-Ortho LLC
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00210496     History of Changes
Other Study ID Numbers: CR002875
Study First Received: September 13, 2005
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen-Ortho LLC:
Migraine headache
Topiramate, Almotriptan malate

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Migraine without Aura
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Almotriptan
Topiramate
Anti-Obesity Agents
Anticonvulsants
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Serotonin Agents
Serotonin Receptor Agonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014