Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-01 @ 1:11 PM
Study NCT ID:
NCT02706795
Status:
COMPLETED
Last Update Posted:
2019-11-06
First Post:
2016-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-escalating Safety and Preliminary Efficacy of DaxibotulinumtoxinA for Injection in Cervical Dystonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014103', 'term': 'Torticollis'}], 'ancestors': [{'id': 'D004421', 'term': 'Dystonia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'dispFirstSubmitDate': '2019-10-30', 'completionDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2016-03-08', 'dispFirstSubmitQcDate': '2019-10-30', 'studyFirstSubmitQcDate': '2016-03-08', 'dispFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of dystonia as measured by change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total Score', 'timeFrame': 'Week 4'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS) - Total Score', 'timeFrame': 'Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24'}, {'measure': 'Change from baseline in TWSTRS subscale scores (Severity, Disability and Pain)', 'timeFrame': 'Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24'}, {'measure': 'Duration of effect based on number of weeks from treatment until return of symptoms that warrant treatment', 'timeFrame': 'Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24'}, {'measure': 'Percentage of treatment responders with at least a 20% reduction in the TWSTRS - Total score post-treatment', 'timeFrame': 'Weeks 2, 4, 6, 9, 12, 16, 20, 24'}, {'measure': 'Patient-rated quality of life measurement based upon change from baseline of the Cervical Dystonia Impact Profile Scale (CDIP-58)', 'timeFrame': 'Post-treatment: Weeks 4, 6, 12, 16, 20, 24'}, {'measure': 'Percentage of responders showing improvement on Clinical Global Impression of Change (CGIC)', 'timeFrame': 'Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24'}]}, 'conditionsModule': {'keywords': ['Cervical dystonia', 'Spasmodic torticollis'], 'conditions': ['Torticollis (Spasmodic)']}, 'referencesModule': {'references': [{'pmid': '30009213', 'type': 'DERIVED', 'citation': 'Jankovic J, Truong D, Patel AT, Brashear A, Evatt M, Rubio RG, Oh CK, Snyder D, Shears G, Comella C. Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose-Escalation Multicenter Study. Mov Disord Clin Pract. 2018 Apr 26;5(3):273-282. doi: 10.1002/mdc3.12613. eCollection 2018 May-Jun.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets diagnostic criteria for isolated cervical dystonia\n* Has moderate severity with a baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total score of at least 20 and a TWSTRS-Severity subscale score or at least 15\n* Has been using stable doses of focal dystonia medications for at least 3 months and willing to continue through end of study\n\nExclusion Criteria:\n\n* Cervical dystonia attributable to an underlying etiology, such as traumatic torticollis or tardive torticollis; predominant retrocollis or anterocollis cervical dystonia\n* Significant dystonia in other body areas, or is currently being treated with botulinum toxin for dystonia in other areas than isolated cervical dystonia\n* Neurological abnormalities other than cervical dystonia\n* History of severe dysphagia or aspiration, or current clinically significant swallowing disorder\n* Previous neck surgery, phenol injection to the neck muscles, myotomy or denervation surgery in the neck/shoulder region, or intrathecal baclofen\n* Marked limitation on passive range of motion that suggests contractures or other structural abnormality, e.g. cervical contractures or cervical spinal deformity\n* Profound atrophy of cervical musculature\n* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis\n* Suboptimal efficacy response to any prior botulinum toxin type A product, when a previous treatment produced more optimal therapeutic response, as judged subjectively by the Investigator\n* Previous treatment with any botulinum toxin product for any condition within the 6 months prior to Screening and during the study; presence of any blood coagulation disorder; or on anticoagulation treatment with international normalized ratio (INR) \\> 3.5'}, 'identificationModule': {'nctId': 'NCT02706795', 'briefTitle': 'Dose-escalating Safety and Preliminary Efficacy of DaxibotulinumtoxinA for Injection in Cervical Dystonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revance Therapeutics, Inc.'}, 'orgStudyIdInfo': {'id': 'RT002-CL005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'daxibotulinumtoxinA (DAXI) for injection', 'description': 'DAXI for injection', 'interventionNames': ['Biological: DaxibotulinumtoxinA']}], 'interventions': [{'name': 'DaxibotulinumtoxinA', 'type': 'BIOLOGICAL', 'description': 'Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study', 'armGroupLabels': ['daxibotulinumtoxinA (DAXI) for injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': "The Parkinson's & Movement Disorder Institute", 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Springs Neurological Associates', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Center for Movement Disorders & Neurorestoration', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Precision Research Organization', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Bone & Joint Clinic', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '70810', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'The NeuroMedical Center Clinic', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake forest Baptist Health', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Riverhills Healthcare, Inc.', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '29935', 'city': 'Port Royal', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Neurology', 'geoPoint': {'lat': 32.37896, 'lon': -80.69265}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Parkinson's Disease Center and Movement Disorder Clinic", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Nubia Kaba', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revance Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}