NCT00195806

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 3, 2007

Status Verified

August 1, 2007

First QC Date

September 14, 2005

Last Update Submit

August 30, 2007

Conditions

Migraine

Keywords

MigraineDepakote ERDivalproex sodium

Outcome Measures

Primary Outcomes (1)

  • Number of migraine headache days

Secondary Outcomes (5)

  • Adverse events

  • Laboratory data

  • Vital signs

  • Study drug exposure

  • Behavioral/cognitive assessments

Interventions

divalproex sodiumDRUG

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Global Medical Information - Abbott

North Chicago, Illinois, 60064, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Global Medical Information 800-633-9110

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 20, 2005

Study Start

February 1, 2005

Last Updated

September 3, 2007

Record last verified: 2007-08

Locations

US(1)