Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.
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ClinicalTrials.gov Identifier: NCT00212810 |
Recruitment Status
:
Completed
First Posted
: September 21, 2005
Last Update Posted
: May 19, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine Headache Classic Migraine Common Migraine | Drug: Topiramate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 385 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | TOPAMAX (Topiramate) Intervention to Prevent Transformation of Episodic Migraine: The Topiramate INTREPID Study |
Study Start Date : | September 2005 |
Actual Study Completion Date : | August 2007 |

- The primary efficacy parameter will be whether or not a patient experiences 15 or more headache days (migraine and non-migraine) during the last 28 days of the study.
- Time to development of transformed migraine;occurrence of transformation as function of baseline headache days;change in the average rate of migraine days;percentage change in the average rate of migraine days;50%,75%, and 100% reduction in migraine days

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- To qualify for this study you must be 18-65 years old
- have a history of migraine headaches for at least 1 year
- experience at least 10 but less than 15 migraine headache days and less than 15 total headache days/month
- able to take oral medication
- able to understand and sign the informed consent and to complete headache diaries.
Exclusion Criteria:
- You will not be able to participate in the study if you previously discontinued Topiramate because it did not make you feel better or it made you feel different
- have migraine aura without headache
- have a positive urine drug screen
- have a history of kidney stones
- have a history of suicide attempt
- pregnant females
- already on a migraine preventive 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 ClinicalTrials.gov identifier (NCT number): NCT00212810
Study Director: | Ortho McNeil Neurologics, Inc. Clinical Trial | Ortho-McNeil Neurologics, Inc. |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00212810 History of Changes |
Other Study ID Numbers: |
CR002854 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | May 19, 2011 |
Last Verified: | March 2010 |
Keywords provided by Ortho-McNeil Neurologics, Inc.:
Migraine Headache Migraine Headache |
Additional relevant MeSH terms:
Headache Disorders, Primary Headache Disorders Migraine Disorders Headache Migraine with Aura Migraine without Aura Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Pain Neurologic Manifestations Signs and Symptoms Topiramate Anticonvulsants Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |