Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-28 @ 6:30 PM
Study NCT ID:
NCT06828861
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D011218', 'term': 'Prader-Willi Syndrome'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D000096803', 'term': 'Imprinting Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-13', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score', 'timeFrame': 'Baseline to Week 12', 'description': "The HQ-CT score is a 9 question, 5-point scale to describe the PWS patient's hyperphagia food-related problem behaviors. It is completed by the patient's caregiver. Each question is scored from 0 to 4. The minimum total score is 0 (hyperphagia related behavior symptoms not exhibited) and the maximum total score is 36 (hyperphagia related behavior symptoms are observed)."}], 'secondaryOutcomes': [{'measure': 'Change in Caregiver Global Impression of Severity (CaGI-S) for Hyperphagia in Prader-Willi patients', 'timeFrame': 'Baseline to Week 12', 'description': "The CaGI-S is a single-item, 7-point scale to describe the severity of the PWS patient's hyperphagia (excessive hunger). It is completed by the patient's caregiver. The minimum score is 1 (not present) and the maximum score is 7 (extremely severe). A higher score indicates a worse severity of hyperphagia."}, {'measure': 'Change in Clinical Global Impression of Severity (CGI-S) Score for Hyperphagia in Prader-Willi patients', 'timeFrame': 'Baseline to Week 12', 'description': "The CGI-S is a single-item, 7-point scale designed to assess the severity of the PWS patient's hyperphagia (excessive hunger). It is assessed by the clinician and considers the clinician's experience with the PWS population. The minimum score is 1 (normal, not at all ill) and the maximum score is 7 (among the most extremely ill patients). A higher score indicates a worse severity of hyperphagia."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prader-Willi Syndrome', 'ARD-101', 'PWS', 'Prader-Willi', 'Prader Willi', 'Prader Willi Syndrome'], 'conditions': ['Hyperphagia', 'Prader-Willi Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS). It will also teach us about the safety of ARD-101.\n\nThe main questions it aims to answer are:\n\n* Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)?\n* What medical problems do participants have when taking ARD-101?\n\nResearchers will compare ARD-101 to a placebo (a look-alike substance that contains no drug) to see if ARD-101 works to treat hyperphagia in PWS subjects.\n\nEligible participants will:\n\n* Take ARD-101 or a placebo every day for 12 weeks.\n* Visit the clinic or have a tele-visit once every 2 to 4 weeks during dosing and then have a tele-visit 4 weeks after stopping the ARD-101 or placebo.\n* Patients/Caregivers will keep a daily diary.\n\nParticipants who complete the study may be eligible to enter an open-label extension study where everyone will receive ARD-101.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented confirmation of Prader-Willi Syndrome (PWS)\n* Stable care setting with same, single designated caregiver for at least 6 months prior to Visit 1\n* At least 10 years of age or older in the US and Australia at the time of consent\n* At least 13 years of age or older in countries outside of the US and Australia\n\nExclusion Criteria:\n\n* Diagnosis of schizophrenia, bipolar disorder, personality disorder or other severe mood, anxiety or eating disorder (other than hyperphagia).\n* Presence of any malignancy within 5 years with the exception of basal or squamous cell carcinoma of the skin, in situ carcinoma of the service, or in situations prostate cancer.\n* Presence of clinically relevant renal, hepatic, pancreatic, cardiovascular, neurological, psychiatric, hematological, pulmonary, or GI abnormality that, in the opinion of the investigator, may preclude the patient from safe completion of the study\n* Adults: systolic blood pressure \\>=160 mmHg and/or diastolic blood pressure \\>=100 mmHg\n* Children and Adolescents: systolic blood pressure \\>=140 mmHg and/or diastolic blood pressure \\>=90 mmHg.\n* Type 1 diabetes mellitus; HbA1c \\>8.5%\n* Use of agents to promote weight gain or loss, alter hunger or appetite within 30 days of Visit 1 and throughout the study.\n* Use of any commercially available medication for the treatment of hyperphagia (i.e., Vykat) within 60 days of randomization and throughout the study.\n* Very high doses of glucocorticoids in the previous 3 months of Visit 1 and throughout the study.'}, 'identificationModule': {'nctId': 'NCT06828861', 'acronym': 'HERO', 'briefTitle': 'ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aardvark Therapeutics, Inc.'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Placebo-controlled Study of ARD-101 for the Treatment of Hyperphagia in Patients With Prader-Willi Syndrome', 'orgStudyIdInfo': {'id': 'AVK-101-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm A', 'description': 'ARD-101', 'interventionNames': ['Drug: ARD-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment Arm B', 'description': 'Placebo for ARD-101', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': '200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks', 'armGroupLabels': ['Treatment Arm B']}, {'name': 'ARD-101', 'type': 'DRUG', 'description': '200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks', 'armGroupLabels': ['Treatment Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233-1711', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hussein Abdul-Latif, MD', 'role': 'CONTACT'}, {'name': 'Tushima Reeves', 'role': 'CONTACT', 'email': 'tfails@uabmc.edu', 'phone': '205-638-9173'}], 'facility': "Children's of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92123', 'city': 'Encinitas', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lynne Bird, MD', 'role': 'CONTACT'}, {'name': 'Katherine Bunda', 'role': 'CONTACT', 'email': 'kbunda@health.ucsd.edu', 'phone': '858-236-5145'}], 'facility': "Rady Children's Hospital", 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Virginia Kimonis, MD', 'role': 'CONTACT'}], 'facility': "Children's Hospital of Orange Country", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diane Stafford, MD', 'role': 'CONTACT'}, {'name': 'Alondra Loyola', 'role': 'CONTACT', 'email': 'aloyola1@stanford.edu', 'phone': '650-725-0641'}], 'facility': 'Stanford Childrens Health Specialty Services', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045-7106', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shawn McCandless, MD', 'role': 'CONTACT'}, {'name': 'Lukas Jacyniuk Moskalis', 'role': 'CONTACT', 'email': 'lukas.jacyniukmoskalis@childrenscolorado.org', 'phone': '720-777-5693'}], 'facility': 'Childrens Hospital Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '19803-3607', 'city': 'Wilmington', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aaron Chidekel, MD', 'role': 'CONTACT'}, {'name': 'Kerry Smallacombe, DO', 'role': 'CONTACT', 'email': 'kerry.smallacombe@nemours.org', 'phone': '302-559-0247'}], 'facility': 'Nemours Children Clinic Wilmington', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '32610-3008', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Miller, MD', 'role': 'CONTACT', 'email': 'millejl@peds.ufl.edu', 'phone': '352-294-8229'}], 'facility': 'UF Shands Childrens Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30322-1047', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Gambello, MD', 'role': 'CONTACT'}, {'name': 'Jean Luan McColl', 'role': 'CONTACT', 'email': 'jean.luan@emory.edu', 'phone': '404-778-8619'}], 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611-2991', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Priya Khanna, MD', 'role': 'CONTACT'}, {'name': 'Madeleine Muller', 'role': 'CONTACT', 'email': 'mmuller@luriechildrens.org', 'phone': '312-227-8290'}], 'facility': "Ann and Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287-0005', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ann Scheimann, MD', 'role': 'CONTACT'}], 'facility': 'The Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55102', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bradley Miller, MD', 'role': 'CONTACT', 'email': 'mille685@umn.edu', 'phone': '612-624-5409'}], 'facility': "University of Minnesota Masonic Children's Hospital", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '11219-2918', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edward Yi, MD', 'role': 'CONTACT'}, {'name': 'Hasan Mustafić', 'role': 'CONTACT', 'email': 'HMustafic@maimo.org', 'phone': '718-283-8170'}], 'facility': 'Maimonides Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11501-4077', 'city': 'Mineola', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jorge Mejia-Corletto, MD', 'role': 'CONTACT', 'email': 'jorge.mejia-corletto@nyulangone.org', 'phone': '516-663-4600'}], 'facility': "NYU Langone Children's Ambulatory Care Center", 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '37232-0005', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Shoemaker, MD', 'role': 'CONTACT'}, {'name': 'Celia Núñez', 'role': 'CONTACT', 'email': 'celia.m.nunez@vumc.org', 'phone': '615-322-4559'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sani Roy, MD', 'role': 'CONTACT'}, {'name': 'Kelsey Citta', 'role': 'CONTACT', 'email': 'kelsey.citta@cookchildrens.org', 'phone': '682-885-6837'}], 'facility': "Cook Children's Medical Center", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78596-7288', 'city': 'Weslaco', 'state': 'Texas', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Texas Valley Clinical Research, LLC', 'geoPoint': {'lat': 26.15952, 'lon': -97.99084}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Isabella Niu, MD', 'role': 'CONTACT'}, {'name': 'Stephanie Purdy', 'role': 'CONTACT', 'email': 'stephanie.purdy@seattlechildrens.org', 'phone': '206-987-2640'}], 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Tania Markovic, MD', 'role': 'CONTACT'}, {'name': 'Tegan Picone', 'role': 'CONTACT', 'email': 'tegan.picone@sydney.edu.au'}], 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Yoon Hi Cho, MD', 'role': 'CONTACT'}, {'name': 'Rochelle Burgess', 'role': 'CONTACT', 'email': 'rochelle.burgess@health.nsw.gov.au'}], 'facility': "The Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Helen Heussler, MD', 'role': 'CONTACT'}, {'name': 'Michael Duhig', 'role': 'CONTACT', 'email': 'Michael.Duhig@health.qld.gov.au'}], 'facility': "Queensland Children's Hospital", 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Josephine Ho, MD', 'role': 'CONTACT'}, {'name': 'Heidi Virtanen', 'role': 'CONTACT', 'email': 'heidi.virtanen@ahs.ca'}], 'facility': "Alberta Children's Hospital Research Institute", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Andrea Haqq, MD', 'role': 'CONTACT'}, {'name': 'Jyoti Singh', 'role': 'CONTACT', 'email': 'jyoti1@ualberta.ca', 'phone': '780-492-1098'}], 'facility': 'Li Ka Shing Centre for Health Research Innovation', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Marina Ybarra, MD', 'role': 'CONTACT'}], 'facility': "Children's Hospital at London Health Sciences Centre", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nathalie Alos, MD', 'role': 'CONTACT'}, {'name': 'Teresa Bouramia', 'role': 'CONTACT', 'email': 'teresa.bouramia.hsj@ssss.gouv.qc.ca'}], 'facility': 'Centre Hospitalier Universitaire Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '31300', 'city': 'Toulouse', 'state': 'Haute-Garonne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gwenaelle Diene, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Toulouse-Hôpital Des Enfants', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '49933', 'city': 'Angers', 'state': 'Maine-et-Loire', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frederic Illouz, MD', 'role': 'CONTACT'}], 'facility': "CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '75013', 'city': 'Paris', 'state': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christine Poitou-Bernert, MD', 'role': 'CONTACT'}], 'facility': 'AP-HP - Hôpital de la Pitié Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Graziella Pinto, MD', 'role': 'CONTACT'}], 'facility': 'AP-HP - Hôpital universitaire Necker-Enfants malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie Montastier, MB', 'role': 'CONTACT'}], 'facility': 'CHU de Toulouse- Hôpital de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '50', 'city': 'Rome', 'state': 'Lazio', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Danilo Fintini, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale Pediatrico Bambino Gesù IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberta Pajno, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale San Raffaele S.r.l. - PPDS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '50139', 'city': 'Florence', 'state': 'Tuscany', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Stagi, MD', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '11852', 'city': 'Bucharest', 'state': 'București', 'status': 'NOT_YET_RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Iuliana Gherlan, MD', 'role': 'CONTACT'}], 'facility': 'Institutul National de Endocrinologie C. I. Parhon', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '41408', 'city': 'Bucharest', 'state': 'București', 'status': 'NOT_YET_RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Madalina Leanca, MD', 'role': 'CONTACT'}], 'facility': 'National University Hospital for Children\'s Neurorehabilitation "Dr. Nicolae Robanescu"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '700125', 'city': 'Iași', 'status': 'NOT_YET_RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Cristina Preda, MD', 'role': 'CONTACT'}], 'facility': 'Spitalul Clinic de Urgenta Sfantul Spiridon', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '06351', 'city': 'Seoul', 'state': 'South Korea', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Yoon Cho, MD', 'role': 'CONTACT'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '22332', 'city': 'Incheon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ji Eun Lee, MD', 'role': 'CONTACT'}], 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '16499', 'city': 'Suwon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young Bae Sohn, MD', 'role': 'CONTACT'}], 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '8208', 'city': 'Sabadell', 'state': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raquel Corripio Collado, MD', 'role': 'CONTACT'}], 'facility': 'Corporacio Sanitaria Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '8035', 'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Eduard Mogas Vinals, PhD', 'role': 'CONTACT'}], 'facility': "Hospital Universitario Vall d'Hebron - PPDS", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Irene Lazaro Rodriquez, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'state': 'Leicestershire', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'James Greening, MD', 'role': 'CONTACT'}], 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'CB21 5EF', 'city': 'Cambridge', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Shahid Zaman, MD', 'role': 'CONTACT'}], 'facility': 'Fulborn Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Mohamad Guftar Shaikh, MBBS', 'role': 'CONTACT'}], 'facility': 'Royal Hospital for Children (Glasgow) - PPDS - PIN', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'E1 4NS', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Evelien Gevers, MD', 'role': 'CONTACT'}], 'facility': 'The Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Robin Schmidt, MS', 'role': 'CONTACT', 'email': 'Info@AardvarkTherapeutics.com', 'phone': '(858) 225-7696'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aardvark Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}