Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 8:53 PM
Study NCT ID:
NCT07088159
Status:
AVAILABLE
Last Update Posted:
2025-12-17
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intermediate-size Patient Population Expanded Access Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Expanded Access Protocol', 'synapse', 'ALS (Amyotrophic Lateral Sclerosis)', 'neural connectivity'], 'conditions': ['ALS (Amyotrophic Lateral Sclerosis)']}, 'descriptionModule': {'briefSummary': 'The purpose of this Expanded Access Program is to provide SPG302 to ALS patients who are not eligible to enroll in an ALS clinical trial. This Expanded Access Program will assess safety and tolerability, and clinical efficacy of SPG302.', 'detailedDescription': 'This is a multi-site, intermediate-size patient population expanded access protocol developed to provide compassionate use access to SPG302 to adult patients with ALS who have progressed following available standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* ALS diagnosis\n* Age 18 -80 years at time of signing informed consent form\n* Ineligible for other interventional ALS clinical research participation\n* Vital Capacity less than 50% of predicted capacity for age, height, and sex\n* If currently taking standard of care treatment for ALS, must be on stable dose for at least 30 days prior to taking SPG302.\n* Life expectancy of at least 6 months, according to Investigator's judgement\n\nExclusion Criteria:\n\n* Clinically significant and/or unstable medical condition (other than ALS) that would pose a risk to the patient\n* Known ongoing or clinically uncontrolled cardiac disease\n* Clinically significant liver disease\n* Clinical significant cognitive impairment or neurological disorder, as determined by Investigator judgement\n* Concomitant use of another investigational medical product for treatment of ALS\n* Unable to reliably and regularly swallow whole oral medications on a daily basis"}, 'identificationModule': {'nctId': 'NCT07088159', 'briefTitle': 'Intermediate-size Patient Population Expanded Access Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spinogenix'}, 'officialTitle': 'Intermediate-size Patient Population Expanded Access Protocol for SPG302 in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)', 'orgStudyIdInfo': {'id': 'SPG302-ALS-ISEAP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SPG302', 'type': 'DRUG', 'description': '300 mg SPG302 will taken by mouth once daily.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Melanie Benge', 'role': 'CONTACT', 'email': 'Melaniebenge@uabmc.edu'}], 'facility': 'University of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Bojko.Alissa@mayo.edu'}], 'facility': 'Mayo Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'GroupNeuromuscularResearch@cshs.org'}], 'facility': 'Cedar-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Daniela Sanchez', 'role': 'CONTACT', 'email': 'daniela.sanchez@sutterhealth.org'}], 'facility': 'California Pacific Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33314', 'city': 'Davie', 'state': 'Florida', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Donovan.mott@nova.edu'}], 'facility': 'Nova Southeastern University', 'geoPoint': {'lat': 26.06287, 'lon': -80.2331}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Sarah Bohlman', 'role': 'CONTACT', 'email': 'research-studies@synapticure.com'}], 'facility': 'Synapticure', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Grace Addy', 'role': 'CONTACT', 'email': 'SPG302healey@mgb.org'}, {'name': 'Klea Tryfoni', 'role': 'CONTACT', 'email': 'SPG302healey@mgb.org'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Gina.E.Kersey@Hitchcock.ORG'}], 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '07901', 'city': 'Summit', 'state': 'New Jersey', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Jillian Anderson, MD', 'role': 'CONTACT', 'email': 'Research@atlantichealth.org'}], 'facility': 'Atlantic Health', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'contact@spinogenix.com'}], 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'contact@spinogenix.com'}], 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '23233', 'city': 'Henrico', 'state': 'Virginia', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'neuromuscular_research@vcuhealth.org'}], 'facility': 'VCU ALS Research Group', 'geoPoint': {'lat': 36.59264, 'lon': -78.61611}}], 'centralContacts': [{'name': 'Project Lead', 'role': 'CONTACT', 'email': 'als302eap@cbcc.global', 'phone': '1 (661) 862-7122'}, {'name': 'Spinogenix Lead, PhD', 'role': 'CONTACT', 'email': 'studyiseap@spinogenix.com', 'phone': '1 (503) 9151400'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spinogenix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}