search
Back to results

Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
divalproex sodium
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Depakote ER, Divalproex sodium

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject and subject's legal representative have voluntarily signed and dated an IRB-approved informed assent form and an IRB-approved informed consent form, respectively, before any study-specific procedures or tests are performed; Subject is male, or a non-pregnant, non-lactating female; Subject is between 12 and 17 years of age, inclusive, at the Screening Visit; Subject weighs at least 77 lbs. (i.e., 35 kg); Subject currently has diagnosis of migraine headaches consistent with International Headache Society (IHS) criteria; Subject is judged to be in generally good health based on the results of a medical history, physical examination, 12-lead electrocardiogram (ECG), and laboratory profile; and In the investigator's opinion, the subject will benefit from Depakote ER for migraine prophylaxis. Exclusion Criteria: History of allergic reaction or significant sensitivity to valproate or similar drugs; History of noncompliance with medication or medical instructions; Recent (previous 6 months) history of drug and/or alcohol abuse or has a positive urine drug screen, at the Screening Visit, for drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and phencyclidine [PCP]); Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives) as judged by the investigator. Use of the following medication classes or any specific drug listed below: anti-depressants, other antiepileptic drugs (AEDs) aspirin and/or aspirin-containing products chronic use of systemic corticosteroids, clonazepam,diazepam, erythromycin, ethosuximide, pemoline, phenobarbital,rifampin,tolbutamide, zidovudine anticoagulant drug therapy; Any serious medical or psychiatric disorder(s), including epilepsy and obesity, that may confound the interpretation of the results from this study; Central nervous system (CNS) neoplasm, CNS infection, demyelinating disease, degenerative neurological disease, or any progressive CNS disease; History of encephalopathy, hepatitis, pancreatitis, or urea-cycle disorder or any underlying condition/disease, which might interfere with study drug absorption or completion of study drug therapy evaluation throughout the duration of the trial; Screening laboratory results indicate the presence of Hepatitis B surface antigen (HBsAg), or Hepatitis C antibody or known history of any positive test result for HIV; Screening laboratory results indicate: Platelet count =/< 100,000/uL ALT or AST =/> 2 times Upper Limit of Normal (ULN); Receipt of an investigational drug within 30 days prior to study drug administration or scheduled to receive any other investigational drug anytime during the study; Participation in a prior Depakote ER migraine study (M02-488 or M02-554); or if for any reason, subject is considered by the investigator to be an unsuitable candidate to receive Depakote or to participate in this study.

Sites / Locations

  • Global Medical Information - Abbott

Outcomes

Primary Outcome Measures

Number of migraine headache days

Secondary Outcome Measures

Adverse events
Laboratory data
Vital signs
Study drug exposure
Behavioral/cognitive assessments

Full Information

First Posted
September 14, 2005
Last Updated
August 30, 2007
Sponsor
Abbott
search

1. Study Identification

Unique Protocol Identification Number
NCT00195806
Brief Title
Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With Migraine
Official Title
Divalproex Sodium Extended-Release Tablets for Migraine Prophylaxis in Adolescents: An Open-Label, Long-Term Safety Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote ER is safe in the reduction of occurrence of migraine headaches in adolescents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Depakote ER, Divalproex sodium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
315 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
divalproex sodium
Primary Outcome Measure Information:
Title
Number of migraine headache days
Secondary Outcome Measure Information:
Title
Adverse events
Title
Laboratory data
Title
Vital signs
Title
Study drug exposure
Title
Behavioral/cognitive assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject and subject's legal representative have voluntarily signed and dated an IRB-approved informed assent form and an IRB-approved informed consent form, respectively, before any study-specific procedures or tests are performed; Subject is male, or a non-pregnant, non-lactating female; Subject is between 12 and 17 years of age, inclusive, at the Screening Visit; Subject weighs at least 77 lbs. (i.e., 35 kg); Subject currently has diagnosis of migraine headaches consistent with International Headache Society (IHS) criteria; Subject is judged to be in generally good health based on the results of a medical history, physical examination, 12-lead electrocardiogram (ECG), and laboratory profile; and In the investigator's opinion, the subject will benefit from Depakote ER for migraine prophylaxis. Exclusion Criteria: History of allergic reaction or significant sensitivity to valproate or similar drugs; History of noncompliance with medication or medical instructions; Recent (previous 6 months) history of drug and/or alcohol abuse or has a positive urine drug screen, at the Screening Visit, for drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and phencyclidine [PCP]); Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives) as judged by the investigator. Use of the following medication classes or any specific drug listed below: anti-depressants, other antiepileptic drugs (AEDs) aspirin and/or aspirin-containing products chronic use of systemic corticosteroids, clonazepam,diazepam, erythromycin, ethosuximide, pemoline, phenobarbital,rifampin,tolbutamide, zidovudine anticoagulant drug therapy; Any serious medical or psychiatric disorder(s), including epilepsy and obesity, that may confound the interpretation of the results from this study; Central nervous system (CNS) neoplasm, CNS infection, demyelinating disease, degenerative neurological disease, or any progressive CNS disease; History of encephalopathy, hepatitis, pancreatitis, or urea-cycle disorder or any underlying condition/disease, which might interfere with study drug absorption or completion of study drug therapy evaluation throughout the duration of the trial; Screening laboratory results indicate the presence of Hepatitis B surface antigen (HBsAg), or Hepatitis C antibody or known history of any positive test result for HIV; Screening laboratory results indicate: Platelet count =/< 100,000/uL ALT or AST =/> 2 times Upper Limit of Normal (ULN); Receipt of an investigational drug within 30 days prior to study drug administration or scheduled to receive any other investigational drug anytime during the study; Participation in a prior Depakote ER migraine study (M02-488 or M02-554); or if for any reason, subject is considered by the investigator to be an unsuitable candidate to receive Depakote or to participate in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information 800-633-9110
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Global Medical Information - Abbott
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With Migraine

We'll reach out to this number within 24 hrs