Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-03-01 @ 10:03 PM
Study NCT ID:
NCT00015457
Status:
COMPLETED
Last Update Posted:
2013-04-01
First Post:
2001-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Amlodipine Plus Botulinum Toxin for Focal Dystonia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020821', 'term': 'Dystonic Disorders'}, {'id': 'D014103', 'term': 'Torticollis'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D017311', 'term': 'Amlodipine'}, {'id': 'D001905', 'term': 'Botulinum Toxins'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karpb@ninds.nih.gov', 'phone': '301-496-0150', 'title': 'Barbara I Karp, MD', 'organization': 'National Institutes of Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Amlodipine', 'description': 'Patients receiving Amlodipine plus botulinum toxin injections during either period.', 'otherNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients receiving Placebo plus botulinum toxin injections during either period.', 'otherNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'hypereosinophila', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'swelling', 'notes': 'ankle edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'Patients receiving Amlodipine plus botulinum toxin injections during either period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients receiving Placebo plus botulinum toxin injections during either period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.00', 'spread': '10.23', 'groupId': 'OG000'}, {'value': '-3.23', 'spread': '6.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-2 month maximal rating', 'description': 'Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Total enrolled less withdrawals from study. One participant completed the study but did not yield analyzeable data'}, {'type': 'SECONDARY', 'title': 'Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine', 'description': 'Patients receiving Amlodipine plus botulinum toxin injections during either period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients receiving Placebo plus botulinum toxin injections during either period.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '12'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'Self reported duration of effect in weeks.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Total enrolled less withdrawals. Less one participant who completed the study but who did not yield analyzeable data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amlodipine Then Placebo', 'description': 'Patients with cervical dystonia receiving botulinum toxin injections plus Amlodipine during the first period and botulinum toxin injections plus Placebo during the second period.'}, {'id': 'FG001', 'title': 'Placebo Then Amlodipine', 'description': 'Patients with cervical dystonia receiving botulinum toxin injections plus Placebo during the first period and botulinum toxin injections plus Amlodipine during the second period.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients recruited from a medical clinic providing botulinum toxin treatment for cervical dystonia. Patients recruited between 6/21/01 and 10/19/06', 'preAssignmentDetails': 'Patients were excluded if response to previous btx injections were not stable, serious medical conditions, pregnancy, abnormal medical screening'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cervical Dystonia', 'description': 'All participants enrolled in study'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'age \\>18', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'lastUpdateSubmitDate': '2013-03-14', 'studyFirstSubmitDate': '2001-04-18', 'resultsFirstSubmitDate': '2013-03-14', 'studyFirstSubmitQcDate': '2001-04-18', 'lastUpdatePostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-14', 'studyFirstPostDateStruct': {'date': '2001-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score', 'timeFrame': '1-2 month maximal rating', 'description': 'Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.'}], 'secondaryOutcomes': [{'measure': 'Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo', 'timeFrame': '3 months', 'description': 'Self reported duration of effect in weeks.'}]}, 'conditionsModule': {'keywords': ["Writer's Cramp", 'Calcium Channel Antagonists', 'Torticollis', 'Chemodenervation'], 'conditions': ['Focal Dystonia']}, 'referencesModule': {'references': [{'pmid': '9783280', 'type': 'BACKGROUND', 'citation': 'Anderson RL, Patel BC, Holds JB, Jordan DR. Blepharospasm: past, present, and future. Ophthalmic Plast Reconstr Surg. 1998 Sep;14(5):305-17.'}, {'pmid': '2300249', 'type': 'BACKGROUND', 'citation': 'Jankovic J, Schwartz K. Botulinum toxin injections for cervical dystonia. Neurology. 1990 Feb;40(2):277-80. doi: 10.1212/wnl.40.2.277.'}, {'pmid': '2213039', 'type': 'BACKGROUND', 'citation': 'Jankovic J, Schwartz K, Donovan DT. Botulinum toxin treatment of cranial-cervical dystonia, spasmodic dysphonia, other focal dystonias and hemifacial spasm. J Neurol Neurosurg Psychiatry. 1990 Aug;53(8):633-9. doi: 10.1136/jnnp.53.8.633.'}]}, 'descriptionModule': {'briefSummary': 'Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.\n\nStudy Population: 20 patients with cervical dystonia\n\nDesign: Double-bind, placebo-controlled clinical trail.\n\nOutcome measures: For patients: dystonia rating scales (Twistrs, Fahn-Marsden dystonia scale, NINDS subjective patient rating scale), and hand grip strength. For healthy volunteers: Amplitude of EDB MEP.', 'detailedDescription': 'Objective: To determine if the calcium channel blocker, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.\n\nStudy Population: 20 patients with cervical dystonia\n\nDesign: Double-bind, placebo-controlled clinical trail.\n\nOutcome measures: dystonia rating scales (TWISTRS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* INCLUSION CRITERIA:\n\nPatients enrolled in Protocol 85-N-0195, Efficacy and Pathophysiology of Botulinum Toxin for Treatment of Involuntary Movement Disorders are eligible for enrollment if they meet the following inclusion and exclusion criteria.\n\nGood general health\n\nFocal hand dystonia or cervical dystonia\n\nStable response to botulinum toxin demonstrated through a series of at least 3 injections over a period of at least a year\n\nBenefit from the 3 immediately prior btx injections rated as 75% or less or a duration of benefit lasting less than or equal to 2 months\n\nNo other medications for dystonia\n\nEXCLUSION CRITERIA:\n\nCervical dystonia accompanied by dysphagia or dyspnea, either before or with botulinum toxin injection\n\nPresent or past cardiac disease, hypertension, arrhythmia or congestive heart failure\n\nAnterocollis or other neck dystonia requiring bilateral anterior neck muscle injections\n\nUse of concomitant medications affecting calcium channels or those metabolized by the cytochrome p450 3A4 system including grapefruit juice, St. John's wort, HIV protease inhibitors, cimetidine, antibiotics (macrolides, fluoroquinones, antifungal, rifampin), antidepressants (fluvoxamine, norfluoxetine), barbiturates, anticonvulsants (carbamazepine, phenytoin), oral diabetes agents (pioglitazone, troglitazone), and glucocorticoids\n\nAllergy to amlodipine or related compounds\n\nPregnany/ nursing\n\nAge less than 18 years of age\n\nAbnormal EKG\n\nAbnormal coagulation profile or liver function tests\n\nUse of anticoagulants"}, 'identificationModule': {'nctId': 'NCT00015457', 'briefTitle': 'Amlodipine Plus Botulinum Toxin for Focal Dystonia', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Trial of Amlodipine Combined With Botulinum Toxin Injections for Focal Dystonia', 'orgStudyIdInfo': {'id': '010147'}, 'secondaryIdInfos': [{'id': '01-N-0147', 'type': 'OTHER', 'domain': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cervical dystonia', 'description': 'cervical dsytonia patinets', 'interventionNames': ['Drug: Amlodipine plus Botulinum toxin']}], 'interventions': [{'name': 'Amlodipine plus Botulinum toxin', 'type': 'DRUG', 'armGroupLabels': ['cervical dystonia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Barbara Karp, M.D.', 'investigatorAffiliation': 'National Institutes of Health Clinical Center (CC)'}}}}