Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 7:32 PM
Study NCT ID:
NCT01684657
Status:
SUSPENDED
Last Update Posted:
2014-05-20
First Post:
2012-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013342', 'term': 'Stuttering'}], 'ancestors': [{'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522667', 'term': 'asenapine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'whyStopped': 'Study transferring to another facility', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-19', 'studyFirstSubmitDate': '2012-07-24', 'studyFirstSubmitQcDate': '2012-09-10', 'lastUpdatePostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stuttering Severity Instrument', 'timeFrame': '10 minutes', 'description': 'This is an objective measure of stuttering in which it captures verbal samples of five minutes speaking during a conversation and 5 minutes of reading a passage.'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression', 'timeFrame': '2 minutes', 'description': 'This is an evaluation of the patient by the investigator as to whether or not the subjects has improved, remained the same, or worsened while in the study.'}, {'measure': 'Barnes Akathisia Scale', 'timeFrame': '3 minutes', 'description': 'Measures how restless the subject is during the examination.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stuttering'], 'conditions': ['Stuttering']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to find out the potential benefits and safety of asenapine (Saphris®) in adults who suffer from the developmental form of stuttering.\n\nIt is hypothesized that individuals who are randomly assigned to asenapine will have an improvement in speech as compared to a placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects can be enrolled in the study only if they meet all of the following criteria:\n\n1. Subjects must satisfy DSM-IV criteria for stuttering.\n2. The nature of stuttering must be developmental in origin with the onset prior to ten years of age.\n3. Subjects must have a score of moderate or higher on the SSI-IV. 4) Women of child-bearing potential are eligible to participate as long as they are practicing a medically accepted form of contraception (i.e. condom with spermicide or diaphragm, oral or depot contraception, or an intrauterine device).\n\n5)Subjects will be male or female from the ages of 18-70. 6)Subjects will be of only English speaking.\n\nExclusion Criteria:\n\nSubjects will be excluded from the study for any of the following reasons:\n\n1. Stuttering related to a known neurologic cause (e.g. head trauma, stroke).\n2. Unstable medical or psychiatric illness.\n3. Active substance abuse within three months prior to study inclusion.\n4. Any illness that would require the concomitant use of a CNS active medication during the course of the study.\n5. Subjects with Parkinson's dementia or other degenerative neurologic illness.\n6. Subjects who are pregnant or nursing an infant.\n7. No minors (under the age of 18) will not be enrolled in this study as the research with this compound in children and adolescents has not been fully performed.\n8. Subjects who suffer from seizures, irregular heartbeat or an elevated blood sugar level (glucose)."}, 'identificationModule': {'nctId': 'NCT01684657', 'briefTitle': 'A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering', 'orgStudyIdInfo': {'id': 'Asenapine Stuttering'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This is the comparator. Placebo will be matched to color, taste, size, and smell.'}, {'type': 'EXPERIMENTAL', 'label': 'Asenapine', 'description': 'This is an atypical antipsychotic that blocks dopamine and increases serotonin. The dosage will be from 2.5 to 10mg daily throughout the study.', 'interventionNames': ['Drug: Asenapine']}], 'interventions': [{'name': 'Asenapine', 'type': 'DRUG', 'otherNames': ['Saphris'], 'description': 'This is an atypical antipsychotic that blocks dopamine and increase the serotonin level.', 'armGroupLabels': ['Asenapine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Gerald Maguire, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCIMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Associate Dean', 'investigatorFullName': 'Gerald Maguire', 'investigatorAffiliation': 'University of California, Irvine'}}}}