Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT00253032
Status:
TERMINATED
Last Update Posted:
2006-03-03
First Post:
2005-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Relief Investigation of NeuroModulation Therapy in Adult Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'TERMINATED', 'statusVerifiedDate': '2006-03', 'lastUpdateSubmitDate': '2006-03-02', 'studyFirstSubmitDate': '2005-11-11', 'studyFirstSubmitQcDate': '2005-11-11', 'lastUpdatePostDateStruct': {'date': '2006-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Chronic Musculoskeletal Pain']}, 'referencesModule': {'references': [{'pmid': '33025213', 'type': 'DERIVED', 'citation': 'Sepulveda-Sanchez JM, Gil-Gil M, Alonso-Garcia M, Vaz Salgado MA, Vicente E, Mesia Barroso C, Rodriguez Sanchez A, Duran G, De Las Penas R, Munoz-Langa J, Velasco G, Hernandez-Lain A, Hilario A, Navarro Martin M, Benavides M, Oleaga L, Cantero Montenegro D, Ruano Y, Sanchez-Gomez P, Martin-Soberon MC, Morales-Llombart R, Pachon V, Pineda E. Phase II Trial of Palbociclib in Recurrent Retinoblastoma-Positive Anaplastic Oligodendroglioma: A Study from the Spanish Group for Research in Neuro-Oncology (GEINO). Target Oncol. 2020 Oct;15(5):613-622. doi: 10.1007/s11523-020-00754-6.'}]}, 'descriptionModule': {'briefSummary': 'The study is being performed to determine the efficacy and safety of Fralex Neuromodulation Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal pain.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT']}, 'identificationModule': {'nctId': 'NCT00253032', 'briefTitle': 'Pain Relief Investigation of NeuroModulation Therapy in Adult Humans', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fralex Therapeutics'}, 'officialTitle': 'PRIMA Study: Pain Relief Investigation of NeuroModulation Therapy in an Adult Population: A Double Blind, Randomized, Multicenter, Placebo Controlled Trial.', 'orgStudyIdInfo': {'id': 'F05001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PRIMA', 'type': 'DEVICE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fralex Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PharmaNet', 'class': 'INDUSTRY'}]}}}