Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-22 @ 11:38 PM
Study NCT ID:
NCT00961766
Status:
COMPLETED
Last Update Posted:
2014-10-28
First Post:
2009-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012585', 'term': 'Sciatica'}], 'ancestors': [{'id': 'D020426', 'term': 'Sciatic Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020932', 'term': 'Nerve Growth Factor'}], 'ancestors': [{'id': 'D009414', 'term': 'Nerve Growth Factors'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-24', 'studyFirstSubmitDate': '2009-08-17', 'studyFirstSubmitQcDate': '2009-08-18', 'lastUpdatePostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants experiencing Adverse Events (AEs)', 'timeFrame': 'Up to 56 days post dosing'}, {'measure': 'Change in Likert numerical pain rating scale', 'timeFrame': 'Up to 56 days post dosing'}, {'measure': 'Change in Quantitative Sensory Test (QST)', 'timeFrame': 'Up to 28 days post dosing', 'description': 'QST; Vibratory, Cool Thermal,'}, {'measure': 'Change in Intra Epidermal Nerve Fiber Density (IENFD)', 'timeFrame': 'Up to 28 days post dosing'}, {'measure': 'Maximum observed serum concentration (Cmax)', 'timeFrame': 'Up to 5 days post dosing'}, {'measure': 'Area under the serum concentration curve (AUC)', 'timeFrame': 'Up to 5 days post dosing'}, {'measure': 'Terminal half-life (t1/2)', 'timeFrame': 'Up to 5 days post dosing'}, {'measure': 'Total body clearance (CL)', 'timeFrame': 'Up to 5 days post dosing'}, {'measure': 'Steady state volume of distribution (Vss)', 'timeFrame': 'Up to 5 days post dosing'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sciatica']}, 'referencesModule': {'references': [{'pmid': '25962165', 'type': 'DERIVED', 'citation': "Rolan PE, O'Neill G, Versage E, Rana J, Tang Y, Galluppi G, Aycardi E. First-In-Human, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study of BG00010, a Glial Cell Line-Derived Neurotrophic Factor Family Member, in Subjects with Unilateral Sciatica. PLoS One. 2015 May 11;10(5):e0125034. doi: 10.1371/journal.pone.0125034. eCollection 2015."}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to determine the safety/tolerability profile, systemic PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Must have a diagnosis of unilateral sciatica, determined by the Investigator. Sciatica symptoms must be present for 6 or more weeks prior to the Screening Visit.\n* Must have a body mass index (BMI) between 18 kg/m2 and 32 kg/m2.\n* Must rate their pain at \\>40 mm on the 100 mm Visual Analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)at the Screening and Baseline Visits.\n\nKey Exclusion Criteria:\n\n* History of malignancy or clinically significant (as determined by the Investigator) allergies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to sciatica), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.\n* History of signs or symptoms of peripheral neuropathy, other than symptoms of sciatica.\n* History of severe allergic or anaphylactic drug-related reactions. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00961766', 'briefTitle': 'Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'Phase 1: A Single-Center, Randomized, Blinded, Placebo-Controlled, Single-Administration, Sequential-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants', 'orgStudyIdInfo': {'id': '103NS101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BG00010 (Neublastin)', 'description': 'Participants may be randomized to escalating doses of BG00010 or matching placebo', 'interventionNames': ['Drug: BG00010 (Neublastin)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants may be randomized to escalating doses of BG00010 or matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BG00010 (Neublastin)', 'type': 'DRUG', 'description': 'Single dose, weight-based IV administration', 'armGroupLabels': ['BG00010 (Neublastin)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single dose IV matched placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}