Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:06 AM
Study NCT ID:
NCT05147220
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2021-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'C537987', 'term': 'Charcot-Marie-Tooth disease, Type 1F'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722911', 'term': 'remibrutinib'}, {'id': 'C527525', 'term': 'teriflunomide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'In order to maintain blinding, a double-dummy design will be used'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible participants will be randomized in a 1:1 ratio'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2021-11-24', 'studyFirstSubmitQcDate': '2021-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized relapse rate (ARR) of confirmed relapses [Core Part]', 'timeFrame': 'From Baseline, up to 30 months', 'description': 'ARR is the average number of confirmed MS relapses in a year'}], 'secondaryOutcomes': [{'measure': 'Time to 3-month confirmed disability progression (3mCDP) on Expanded Disability Status Scale (EDSS) [Core Part] (pooled data)', 'timeFrame': 'Baseline up to 30 months', 'description': 'Time to 3-month confirmed disability progression (3mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 3 months'}, {'measure': 'Time to 6-month confirmed disability progression (6mCDP) on EDSS [Core Part] (pooled data)', 'timeFrame': 'Baseline up to 30 months', 'description': 'Time to 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 6 months'}, {'measure': 'Annualized rate of new or enlarging T2 lesion [Core Part]', 'timeFrame': 'Baseline up to 30 months', 'description': 'Number of new/newly enlarged T2 lesions per year'}, {'measure': 'Neurofilament light chain (Nfl) [Core Part]', 'timeFrame': 'Baseline up to 30 months', 'description': 'Neurofilament light chain (NfL) concentration in serum'}, {'measure': 'Number of Gd-enhancing T1 lesions per MRI scan [Core Part]', 'timeFrame': 'Baseline up to 30 months', 'description': 'Average number of Gd-enhancing T1 lesions per scan'}, {'measure': 'Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3) [Core Part] (pooled data)', 'timeFrame': 'Baseline up to 30 months', 'description': 'Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6mCDP and new/enlarging T2 lesions on MRI'}, {'measure': 'Time to first confirmed relapse [Core Part]', 'timeFrame': 'Baseline up to 30 months', 'description': 'Change in the Expanded Disability Status Scale (EDSS), an increase of at least 0.5 points on the EDSS (total) score, or an increase of at least 1 point on at least two functional scores (FSs), or an increase of at least 2 points on at least one FS, excluding changes involving bowel/bladder or cerebral FS, compared to the previous available rating.'}, {'measure': 'Time to 6-month confirmed disability improvement (6mCDI) on EDSS [Core Part] (pooled data)', 'timeFrame': 'Baseline up to 30 months', 'description': 'Decrease in Expanded Disability Status Scale Score (EDSS) which is sustained for at least 6 months'}, {'measure': 'Time to 3-months confirmed disability progression (3mCDP) and 6-month confirmed disability progression (6mCDP) independent of relapse activity (PIRA) [Core Part] (pooled data)', 'timeFrame': 'Baseline up to 30 months', 'description': 'Time to 3-month confirmed disability progression (3mCDP) and 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 3 months or 6 months, respectively, without an on-study relapse before or on the day of a progression event.'}, {'measure': 'Change from baseline in the Symbol Digit Modalities Test (SDMT) [Core Part] (pooled data)', 'timeFrame': 'Baseline up to 30 months', 'description': 'Symbol Digit Modalities Test (SDMT), an array of symbols paired with empty spaces, measures processing in speed; participants verbally match the number for each symbol as rapidly as possible. The score is the number of correctly coded items in 90 seconds. Higher scores indicate improvement. Lower scores indicate worsening'}, {'measure': 'Time to 6-month confirmed worsening by at least 20% in the Timed 25-foot walk test (T25FW) [Core Part] (pooled data)', 'timeFrame': 'Baseline, up to 30 months', 'description': 'The patient walking speed to cover 25-foot distance is recorded in seconds. Longer time indicates poorer lower limb function. 20% worsening is defined as 20% increase from baseline T25FW score'}, {'measure': 'Time to 6-month confirmed worsening by at least 20% in the Timed 9-hole peg test (9HPT) (pooled data) [Core Part] (pooled data)', 'timeFrame': 'Baseline up to 30 months', 'description': "The patient's right and left arm function to peg 9 holes measured in seconds. Longer time indicates poorer upper limb function. 20% worsening is defined as 20% increase from baseline 9HPT score in at least one hand (average of two trials per hand)"}, {'measure': 'Time to composite 6-month confirmed disability Progression (CDP) [Core Part] (pooled data)', 'timeFrame': 'Baseline up to 30 months', 'description': 'The composite involves CDP and worsening by at least 20% in T25FW and 9HPT'}, {'measure': 'Change from Baseline in T2 lesion volume [Core Part]', 'timeFrame': 'Baseline up to 30 months', 'description': 'Change from baseline in total T2 lesion volume.'}, {'measure': 'Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Core Part]', 'timeFrame': 'Baseline up to 30 months', 'description': '29-item, self-administered questionnaire that includes 2 domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day to day life'}, {'measure': 'Number of participants with Adverse events and Serious adverse events(SAE) [Core Part]', 'timeFrame': 'Baseline up to 30 months', 'description': 'Adverse events and SAEs including clinically significant , laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating'}, {'measure': 'Pharmacokinetics of remibrutinib [Core Part]', 'timeFrame': 'Month 1, Month 6', 'description': 'Blood concentrations of remibrutinib'}, {'measure': 'Number of participants with Adverse events and Serious adverse events (SAE) [Extension Part]', 'timeFrame': 'Day 1 Extension up to 5 years', 'description': 'Adverse events and SAEs including clinically significant, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating'}, {'measure': 'Annualized relapse rate (ARR) of confirmed relapses [Extension Part]', 'timeFrame': 'Day 1 Extension up to 5 years', 'description': 'ARR is the average number of confirmed MS relapses in a year'}, {'measure': 'Annualized rate of new or enlarging T2 lesion [Extension Part]', 'timeFrame': 'Day 1 Extension up to 5 years', 'description': 'Number of new/newly enlarged T2 lesions per year'}, {'measure': 'Time to 6-month confirmed disability progression (6mCDP) on EDSS [Extension Part]', 'timeFrame': 'Day 1 Extension up to 5 years', 'description': 'Time to 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 6 months'}, {'measure': 'Change from baseline in the Symbol Digit Modalities Test (SDMT) [Extension Part]', 'timeFrame': 'Day 1 Extension up to 5 years', 'description': 'Symbol Digit Modalities Test (SDMT), an array of symbols paired with empty spaces, measures processing in speed; participants verbally match the number for each symbol as rapidly as possible. The score is the number of correctly coded items in 90 seconds. Higher scores indicate improvement. Lower scores indicate worsening'}, {'measure': 'Neurofilament light chain (NfL) [Extension Part]', 'timeFrame': 'Day 1 Extension up to 5 years', 'description': 'Neurofilament light chain (NfL) concentration in serum'}, {'measure': 'Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Extension Part]', 'timeFrame': 'Day 1 Extension up to 5 years', 'description': '29-item, self-administered questionnaire that includes 2 domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day to day life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MS', 'RMS', 'RRMS', 'active secondary progressive multiple sclerosis SPMS', 'remibrutinib', 'LOU064', 'teriflunomide', 'adult', 'relapse', 'Expanded Disability Status Scale', 'T2 lesions', 'T1 lesions', 'GD- enhancing MRI', 'Neurofilament light chain', 'McDonald diagnostic criteria'], 'conditions': ['Relapsing Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)', 'detailedDescription': 'The study CLOU064C12301 consists of an initial Core Part (CP) (maximum duration per participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years duration) for eligible participants.\n\nThe Core Part is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study in approximately 800 participants with relapsing multiple sclerosis (RMS).\n\nThe Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years.\n\nA second study of identical design (CLOU064C12302) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 55 years of age\n* Diagnosis of RMS according to the 2017 McDonald diagnostic criteria\n* At least: 1 documented relapse within the previous year. OR 2 documented relapses within the previous 2 years, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months.\n* EDSS score of 0 to 5.5 (inclusive)\n* Neurologically stable within 1 month\n\nExclusion Criteria:\n\n* Diagnosis of primary progressive multiple sclerosis (PPMS)\n* Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening\n* History of clinically significant CNS disease other than MS\n* Ongoing substance abuse (drug or alcohol)\n* History of malignancy of any organ system (other than complete resection of localized basal cell carcinoma of the skin or in situ cervical cancer),\n* Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or Neurological symptoms consistent with PML\n* suicidal ideation or behavior\n* Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary , renal, hepatic, endocrine, metabolic, hematological disorders or gastrointestinal disease that can interfere with interpretation of the study results or protocol adherence\n* Participants who have had a splenectomy\n* Active clinically significant systemic bacterial, viral, parasitic or fungal infections\n* Positive results for syphilis or tuberculosis testing\n* Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids\n* Active, chronic disease of the immune system (including stable disease treated with immune therapy (e.g. Leflunomide, Methotrexate)) other than MS (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.) with the exception of well-controlled diabetes or thyroid disorder.\n* Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody\n* History or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis (including all Child-Pugh classes) or hepatic failure or any chronic liver or biliary disease.\n* History of severe renal disease or creatinine level\n* Participants at risk of developing or having reactivation of hepatitis\n* Hematology parameters at screening:\n\n * Hemoglobin: \\< 10 g/dl (\\<100g/L)\n * Platelets: \\< 100000/mm3 (\\<100 x 109/L)\n * Absolute lymphocyte count \\< 800/mm3 (\\<0.8 x 109/L)\n * White blood cells: \\<3 000/mm3 (\\<3.0 x 109/L)\n * Neutrophils: \\< 1 500/mm3 (\\<1.5 x 109/L)\n * B-cell count \\< 50% lower limit of normal (LLN) or total IgG \\& total IgM \\< LLN (only required for participants who had a history of receiving B-cell therapies, such as rituximab, ocrelizumab or ofatumumab, prior to screening)\n* History or current diagnosis of significant ECG abnormalities\n* Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment as per central ECG reading at screening visit\n* Use of other investigational drugs\n* Requirement for anticoagulant medication or use of dual anti-platelet therapy Significant bleeding risk or coagulation disorders,\n* History of gastrointestinal bleeding\n* Major surgery within 8 weeks prior to screening\n* History of hypersensitivity to any of the study drugs or excipients\n* Pregnant or nursing (lactating) female participants, prior to randomization\n* Women of childbearing potential not using highly effective contraception\n* Sexually active males not agreeing to use condom\n* Have received any live or live-attenuated vaccines within 6 weeks of randomization or requirement to receive these vaccinations during study\n* Use of strong CYP3A4 inhibitors or use of moderate or strong CYP3A4 inducers within two weeks prior to randomization\n\nInclusion to Extension part:\n\n• Participants who complete the Core Part of the study on double-blind study treatment and conduct the Accelerated Elimination Procedure (AEP)\n\nOther inclusion and exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT05147220', 'acronym': 'REMODEL-1', 'briefTitle': 'Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib', 'orgStudyIdInfo': {'id': 'CLOU064C12301'}, 'secondaryIdInfos': [{'id': '2020-005899-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remibrutinib - Core', 'description': 'Remibrutinib tablet and matching placebo of teriflunomide capsule', 'interventionNames': ['Drug: Remibrutinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Teriflunomide - Core', 'description': 'Teriflunomide capsule and matching placebo remibrutinib tablet', 'interventionNames': ['Drug: Teriflunomide']}, {'type': 'EXPERIMENTAL', 'label': 'Remibrutinib - Extension', 'description': 'Participants on remibrutinib in Core will continue on remibrutinib tablet', 'interventionNames': ['Drug: Remibrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Remibrutinib - Extension (on teriflunomide in Core)', 'description': 'Participants on teriflunomide in Core will switch to remibrutinib tablet', 'interventionNames': ['Drug: Remibrutinib']}], 'interventions': [{'name': 'Remibrutinib', 'type': 'DRUG', 'otherNames': ['LOU064'], 'description': 'tablet taken orally', 'armGroupLabels': ['Remibrutinib - Core', 'Remibrutinib - Extension', 'Remibrutinib - Extension (on teriflunomide in Core)']}, {'name': 'Teriflunomide', 'type': 'DRUG', 'description': 'capsule taken orally', 'armGroupLabels': ['Teriflunomide - Core']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85037', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'AZ Integrated Neuro and Spine', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Honor Health Research Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85718', 'city': 'Tucson', 'state': 'Arizona', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Center for Neurosciences', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'The Belinga Clinic', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maya Eshel', 'role': 'CONTACT', 'email': 'Maya.Eshel@sutterhealth.org', 'phone': '510-849-0417'}, {'name': 'Deepak Soneji', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Research and Education Inst. of Alta Bates Summit Med. Grp', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'The Neuron Clinic', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Neur Ctr of N Orange County', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Glendale Adventist Medical Center', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madison Martin', 'role': 'CONTACT', 'email': 'Madison.Martin@hoag.org', 'phone': '800-400-4624'}, {'name': 'Yasir Jassam', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hoag Health System', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'SC3 Research Pasadena', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '91767', 'city': 'Pomona', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ikram Rfifa', 'role': 'CONTACT', 'email': 'ikram@amctrials.com', 'phone': '909-267-7495'}, {'name': 'Sadiq Altamimi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neuro Center', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '81621', 'city': 'Basalt', 'state': 'Colorado', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Mountain Neuro Research Center PC', 'geoPoint': {'lat': 39.36887, 'lon': -107.03282}}, {'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Alpine Clinical Research Center', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Theresa Whitehead Izwylde', 'role': 'CONTACT', 'email': 'Theresa.Izwylde@Christianacare.org', 'phone': '+1 302 623 3844'}, {'name': 'Jason M Silversteen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anu Bhooshan', 'role': 'CONTACT', 'email': 'anu.r.bhooshan@medstar.net', 'phone': '202-877-6607'}, {'name': 'Brian Barry', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32714', 'city': 'Altamonte Springs', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Neurology of Central FL Res Ctr', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Susan Black', 'role': 'CONTACT', 'email': 'sblack@arrowtrials.com'}, {'name': 'David Billmeier', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arrow Clinical Trials', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '33033', 'city': 'Homestead', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Homestead Assoc In Research Inc', 'geoPoint': {'lat': 25.46872, 'lon': -80.47756}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yuisy Obregon', 'role': 'CONTACT', 'email': 'Yobregon@associatesinresearch.com', 'phone': '786-801-0912'}, {'name': 'Carlos Ramirez-Calderon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Reliant Medical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'US Associates in Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Neurological Services of Orlando PA', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Orlando Health Clinical Trials', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32825', 'city': 'Orlando', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Comprehensive Neurology Clinic', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Neurology Associates of Ormond Beach', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patricia Trumble', 'role': 'CONTACT', 'email': 'trishtmigraine79@gmail.com', 'phone': '941-764-0800'}, {'name': 'Liliana Montoya', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neurostudies Inc', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '33777', 'city': 'Seminole', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Accel Research Sites St Pete-Largo', 'geoPoint': {'lat': 27.83975, 'lon': -82.79121}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Axiom Clinical Research of Florida', 'geoPoint': {'lat': 27.94752, 'lon': 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