Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-30 @ 4:36 PM
Study NCT ID:
NCT01873404
Status:
COMPLETED
Last Update Posted:
2015-09-10
First Post:
2013-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012585', 'term': 'Sciatica'}, {'id': 'D011843', 'term': 'Radiculopathy'}], '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': 'C490886', 'term': 'ARTN protein, human'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'dispFirstSubmitDate': '2015-08-27', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-27', 'studyFirstSubmitDate': '2013-05-07', 'dispFirstSubmitQcDate': '2015-08-27', 'studyFirstSubmitQcDate': '2013-06-06', 'dispFirstPostDateStruct': {'date': '2015-09-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score', 'timeFrame': 'At the end of treatment period (Day 6-10)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in the mean 24-hour average back pain intensity (ABPI) score', 'timeFrame': 'At the end of the treatment period (day 6-10)'}, {'measure': 'Change from Baseline in the mean 24-hour average leg pain intensity score (ALPI)', 'timeFrame': 'At the end of the treatment period (day 6-10)'}, {'measure': 'Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI)', 'timeFrame': 'Up to week 5'}, {'measure': 'Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI)', 'timeFrame': 'Up to week 5'}, {'measure': 'Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI)', 'timeFrame': 'Up to week 5'}, {'measure': 'Maximum observed serum concentration (Cmax) of BG00010', 'timeFrame': 'Up to Day 5'}, {'measure': 'Number of participants experiencing adverse events (AEs)', 'timeFrame': 'Up to week 9'}, {'measure': 'Number of participants experiencing serious adverse events (SAEs)', 'timeFrame': 'Up to week 9'}, {'measure': 'Change from Baseline in Incidence of neutralizing antibodies in serum', 'timeFrame': 'Up to week 9'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Painful Lumbar Radiculopathy', 'Sciatica', 'Radiculopathy']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to assess the efficacy of Intravenous (IV) BG00010 (Neublastin) in improving pain in painful lumbar radiculopathy participants when administered 3 times per week for 1 week.\n\nThe secondary objectives of this study in this study population are as follows: To explore the duration of the effect of BG00010 in improving pain; To explore the dose response curve on pain reduction; To assess the safety and tolerability of BG00010; To assess the serum exposure to BG00010.', 'detailedDescription': 'During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Body weight ≤133 kg.\n* Leg pain radiating, diagnosed as being due to painful lumbar radiculopathy or lumbosacral radiculopathy, the diagnosis of which occurred within ≥6 months and ≤5 years of the time of randomization.\n* Objective, documented evidence of painful lumbar radiculopathy involvement\n* Lower back pain\n* Leg pain\n* Male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.\n\nKey Exclusion Criteria:\n\n* History of or positive test result at screening for human immunodeficiency virus, or for hepatitis C virus antibody, or current Hepatitis B infection.\n* Clinically significant diseases or conditions as determined by the investigator.\n* Major surgery within 30 days prior to the Screening Visit or that is scheduled to occur during the study.\n* Previous participation in a study with neurotrophic factors (e.g., nerve growth factor).\n* Participation in a study with another investigational drug or approved therapy for investigational use within 3 months prior to Day 1.\n* Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec Inc. (Biogen Idec), make the subject unsuitable for enrollment\n\nNOTE: Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01873404', 'acronym': 'SPRINT', 'briefTitle': 'BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Using a Bayesian Adaptive Design to Assess the Efficacy, Safety, Tolerability, and Serum Exposure of Multiple Doses of BG00010 (Neublastin) in Subjects With Painful Lumbar Radiculopathy', 'orgStudyIdInfo': {'id': '103NS201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BG00010', 'description': 'Administered as an IV injection at various dose levels 3 times per week for 1 week', 'interventionNames': ['Drug: BG00010']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matched placebo IV injection 3 times per week for 1 week', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BG00010', 'type': 'DRUG', 'otherNames': ['Neublastin'], 'description': 'As specified in the treatment arm', 'armGroupLabels': ['BG00010']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'As specified in the treatment arm', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90717', 'city': 'Lomita', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '33312', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33713', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33351', 'city': 'Sunrise', 'state': 'Florida', 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'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '78731', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}