Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-02-25 @ 7:26 PM
Study NCT ID:
NCT00195806
Status:
COMPLETED
Last Update Posted:
2007-09-03
First Post:
2005-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014635', 'term': 'Valproic Acid'}], 'ancestors': [{'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'statusVerifiedDate': '2007-08', 'lastUpdateSubmitDate': '2007-08-30', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2007-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of migraine headache days'}], 'secondaryOutcomes': [{'measure': 'Adverse events'}, {'measure': 'Laboratory data'}, {'measure': 'Vital signs'}, {'measure': 'Study drug exposure'}, {'measure': 'Behavioral/cognitive assessments'}]}, 'conditionsModule': {'keywords': ['Migraine', 'Depakote ER', 'Divalproex sodium'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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;\n* Subject is male, or a non-pregnant, non-lactating female;\n* Subject is between 12 and 17 years of age, inclusive, at the Screening Visit;\n* Subject weighs at least 77 lbs. (i.e., 35 kg);\n* Subject currently has diagnosis of migraine headaches consistent with International Headache Society (IHS) criteria;\n* 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\n* In the investigator's opinion, the subject will benefit from Depakote ER for migraine prophylaxis.\n\nExclusion Criteria:\n\n* History of allergic reaction or significant sensitivity to valproate or similar drugs;\n* History of noncompliance with medication or medical instructions;\n* 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\\]);\n* 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.\n* Use of the following medication classes or any specific drug listed below:\n\n * anti-depressants, other antiepileptic drugs (AEDs)\n * aspirin and/or aspirin-containing products\n * chronic use of systemic corticosteroids, clonazepam,diazepam, erythromycin, ethosuximide, pemoline, phenobarbital,rifampin,tolbutamide, zidovudine\n * anticoagulant drug therapy;\n* Any serious medical or psychiatric disorder(s), including epilepsy and obesity, that may confound the interpretation of the results from this study;\n* Central nervous system (CNS) neoplasm, CNS infection, demyelinating disease, degenerative neurological disease, or any progressive CNS disease;\n* 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;\n* 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;\n* Screening laboratory results indicate:\n\n 1. Platelet count =/\\< 100,000/uL\n 2. ALT or AST =/\\> 2 times Upper Limit of Normal (ULN);\n* 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;\n* 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."}, 'identificationModule': {'nctId': 'NCT00195806', 'briefTitle': 'Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Divalproex Sodium Extended-Release Tablets for Migraine Prophylaxis in Adolescents: An Open-Label, Long-Term Safety Study', 'orgStudyIdInfo': {'id': 'M03-648'}}, 'armsInterventionsModule': {'interventions': [{'name': 'divalproex sodium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60064', 'city': 'North Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Global Medical Information - Abbott', 'geoPoint': {'lat': 42.32558, 'lon': -87.84118}}], 'overallOfficials': [{'name': 'Global Medical Information 800-633-9110', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}}}}