An Open Label Extension of a Study Comparing Topiramate a... | NCT00210860

Studies
An Open Label Extension of a Study Comparing Topiramate and Amitriptyline in Migraine Prevention.

NCT00210860

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Status

Completed

Last Update Posted

Jun 10, 2011Estimated

Enrollment

142Actual

Phase

Phase 3

Conditions

Migraine

Interventions

topiramate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Mar 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2011

Last Update Posted Date

Jun 10, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.INDUSTRY

Collaborators

Name	Class
Ortho-McNeil Neurologics, Inc.	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to assess the long-term safety and effectiveness of topiramate for the prevention of migraine headaches in adults. Topiramate has been approved to prevent migraine headaches in adults.

Detailed Description

Migraine headaches can be disabling and can interfere with work and a person's quality of life. Preventing these headaches before they start is the best option. Topiramate, an anti-seizure medication, has been shown to help prevent migraine headaches from occurring. This is an open-label study that is an extension of a previous study (CAPSS-277) comparing topiramate and amitriptyline in migraine prevention. It includes patients who completed the previous study and elected to enter open label treatment with topiramate. The study will involve a 4-week Blinded Transition Phase during which patients will be titrated up to a daily topiramate dose of 100 milligrams (or the maximum tolerated dose, whichever is less). Then there will be a 12-week Open-Label Maintenance Phase during which the topiramate dose may be adjusted according to effectiveness and tolerance, but not to exceed a daily dose of 400 milligrams. While on topiramate, patients will record daily entries in their headache records. Patients will be asked questions to help assess their quality of life. Patients will also have physical examinations and laboratory tests performed during the study. The objective of this study is to evaluate the long-term safety and effectiveness of topiramate for the prevention of migraine headaches.

Topiramate oral tablets, 25 milligrams per tablet, will be given in the morning and evening to a dose not to exceed 400 milligrams per day or to the maximum tolerated dose, whichever is less

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Name	Type	Description	Arm Group Labels	Other Names
topiramate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient diary: number, duration, severity of headaches, symptoms, other medications used; QOL: Migraine Disability Assessment, Migraine-Specific Quality of Life, Quality of Life Enjoyment & Satisfaction Questionnaire-Short Form, Weight Satisfaction Scale

Secondary Outcomes

Measure	Description	Time Frame
Adverse event reports; physical examinations; vital signs; electrocardiogram; laboratory tests for safety

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of migraine with or without aura
Successfully finished CAPSS-277 study
In generally good health
Able to take medicine orally
If female, using birth control

Exclusion Criteria:

Not having a more painful condition than the headache pain
Cannot be taking any other medications not allowed by the study
Abnormal liver tests
Not compliant with study medication during the CAPSS-277 study
Pregnant or breast-feeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Study Director

Locations

Not provided

References Module

Citations

Not provided

ID	Term
D008881	Migraine Disorders
D000092122	Bronchiolitis Obliterans Syndrome
D006261	Headache

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D005632	Fructose
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241