Painful Lumbar RadiculopathyPhase 1NCT01842126
Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)
A Phase 1 study testing BG00010 IV and BG00010 SC in people with Painful Lumbar Radiculopathy and Healthy, run by Biogen at 1 site in Netherlands.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of a range of single intravenous (IV) and subcutaneous (SC) doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in participants with painful lumbar radiculopathy. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Painful Lumbar Radiculopathy, Healthy
- What is being tested?
- BG00010 IV and BG00010 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2013to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers
- Key Inclusion Criteria: Part III multiple ascending dose (MAD)
- Subjects must have a diagnosis of unilateral painful lumbar radiculopathy and painful lumbar radiculopathy symptoms must be present for 3 or more months prior to the Screening Visit.
- Subjects 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.
- Key Inclusion Criteria for All Subjects for Part I, Part II, Part III:
- All male subjects and all 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. -
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- Key Exclusion Criteria for All Subjects for Part I, Part II, Part III:
- History of or positive screening test for hepatitis C infection , hepatitis B infection, or positive for human immunodeficiency virus (HIV) antibody. Subjects who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive are allowed to participate if they are positive for HBsAb immunoglobulin G
- History of malignancy or clinically relevant (as determined by the Investigator) allergies; cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to painful lumbar radiculopathy), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
- Relevant history of illicit drug or alcohol abuse (as defined by the Investigator) within 1 year prior to the Screening Visit. -
- Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at the Screening or Baseline Visits.
- Previous administration of a neurotrophic factor, including BG00010.
- Participation in a study with another investigational drug or approved therapy for investigational use within the 3 months prior to the Baseline Visit, or current enrollment in any other study.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Safety, Tolerability, and Pharmacokinetics of BG00010 (Neublastin) Intravenous and Subcutaneous Single Ascending Doses in Healthy Volunteers, and Subcutaneous Multiple Ascending Doses in Subjects With Painful Lumbar Radiculopathy
The primary objective of the study is to evaluate the safety and tolerability of a range of single intravenous (IV) and subcutaneous (SC) doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in participants with painful lumbar radiculopathy. Secondary objectives of this study are to determine the single IV and SC dose pharmacokinetics (PK) profile of BG00010 in healthy volunteers including assessment of bioavailability by comparing SC exposure to IV exposure in each participant, to determine the multiple SC dose PK profiles of BG00010 in participants with painful lumbar radiculopathy, to assess the single IV and SC dose immunogenicity of BG00010 in healthy volunteers, to assess the multiple SC dose immunogenicity of BG00010 in participants with painful lumbar radiculopathy, and to assess the potential of BG00010 to reduce pain following multiple SC administrations in participants with painful lumbar radiculopathy.
- Conditions
- Painful Lumbar Radiculopathy, Healthy
- Being tested
- BG00010 IV, BG00010 SC, Placebo IV, Placebo SC
- Keywords
- Sciatica
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG00010 IVBiological
Also called Neublastin
Ascending Doses intravenous (IV) of BG00010
BG00010 SCBiological
Also called Neublastin
Ascending Doses subcutaneous (SC) of BG00010
Placebo IVDrug
Ascending Doses intravenous (IV) of Placebo
Placebo SCDrug
Ascending Doses subcutaneous (SC) of placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD): BG00010 | Experimental | Up to five cohorts of healthy volunteers will receive a single dose of intravenous (IV) BG00010 followed by a single SC dose of BG00010 2 weeks apart. Receives: Biological: BG00010 IV; Biological: BG00010 SC |
| SAD: Placebo | Experimental | Up to five cohorts of healthy volunteers will receive a single IV dose of placebo followed by a single SC dose of placebo 2 weeks apart. Receives: Drug: Placebo IV; Drug: Placebo SC |
| Multiple Ascending Dose (MAD): BG00010 | Experimental | Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of BG00010. Receives: Biological: BG00010 SC |
| Multiple Ascending Dose (MAD): Placebo | Experimental | Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of placebo. Receives: Drug: Placebo SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)
Measured: Up to Day 75
Secondary outcomes (8)
Maximum observed concentration (Cmax) of BG00010
Measured: Pre-dose and up to 24 hours post-dose
Time to maximum serum concentration (Tmax) of BG00010
Measured: Pre-dose and up to 24 hours post-dose
Half life (t1/2) of BG00010
Measured: Pre-dose and up to 24 hours post-dose
Area under the serum concentration time curve (AUC) from zero to infinity AUC(0-∞) for BG00010
Measured: Pre-dose and up to 24 hours post-dose
Subcutaneous (SC) bioavailability
Measured: Pre-dose and up to 24 hours post-dose
Number of participants with anti-BG00010 antibodies in serum
Measured: Up to Day 75
Pain as measured by an 11-point numeric rating scale (NRS)
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. The scale ranges from 0 (no pain) to 10 (worst pain imaginable).
Measured: Up to Day 75
Pain as measured by short form McGill pain questionnaire (SF-MPQ) visual analog scale (VAS)
A 10 cm visual analog scale ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Up to Day 75
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842126
- Sponsor's protocol ID
- 103NS103
- Other IDs
- 2012-005224-15
- Status last verified
- Feb 2015
- First submitted
- 25 Apr 2013
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Safety, Tolerability, and Pharmacokinetics of BG00010 (Neublastin) Intravenous and Subcutaneous Single Ascending Doses in Healthy Volunteers, and Subcutaneous Multiple Ascending Doses in Subjects With Painful Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT01842126
- Acronym / sponsor ID
- 103NS103
- Conditions
- Painful Lumbar Radiculopathy, Healthy
- Keywords
- Sciatica
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the safety and tolerability of a range of single intravenous (IV) and subcutaneous (SC) doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in participants with painful lumbar radiculopathy. Secondary objectives of this study are to determine the single IV and SC dose pharmacokinetics (PK) profile of BG00010 in healthy volunteers including assessment of bioavailability by comparing SC exposure to IV exposure in each participant, to determine the multiple SC dose PK profiles of BG00010 in participants with painful lumbar radiculopathy, to assess the single IV and SC dose immunogenicity of BG00010 in healthy volunteers, to assess the multiple SC dose immunogenicity of BG00010 in participants with painful lumbar radiculopathy, and to assess the potential of BG00010 to reduce pain following multiple SC administrations in participants with painful lumbar radiculopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD): BG00010 | Experimental | Biological: BG00010 IV, Biological: BG00010 SCUp to five cohorts of healthy volunteers will receive a single dose of intravenous (IV) BG00010 followed by a single SC dose of BG00010 2 weeks apart. |
| SAD: Placebo | Experimental | Drug: Placebo IV, Drug: Placebo SCUp to five cohorts of healthy volunteers will receive a single IV dose of placebo followed by a single SC dose of placebo 2 weeks apart. |
| Multiple Ascending Dose (MAD): BG00010 | Experimental | Biological: BG00010 SCUp to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of BG00010. |
| Multiple Ascending Dose (MAD): Placebo | Experimental | Drug: Placebo SCUp to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy Volunteers
- Key Inclusion Criteria: Part III multiple ascending dose (MAD)
- Subjects must have a diagnosis of unilateral painful lumbar radiculopathy and painful lumbar radiculopathy symptoms must be present for 3 or more months prior to the Screening Visit.
- Subjects 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.
- All male subjects and all 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. -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BG00010 IVAlso: NeublastinAscending Doses intravenous (IV) of BG00010 | Biological | Single Ascending Dose (SAD): BG00010 |
| BG00010 SCAlso: NeublastinAscending Doses subcutaneous (SC) of BG00010 | Biological | Multiple Ascending Dose (MAD): BG00010, Single Ascending Dose (SAD): BG00010 |
| Placebo IVAscending Doses intravenous (IV) of Placebo | Drug | SAD: Placebo |
| Placebo SCAscending Doses subcutaneous (SC) of placebo | Drug | Multiple Ascending Dose (MAD): Placebo, SAD: Placebo |
Primary outcome
The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)
Time frame: Up to Day 75
8 secondary outcomes
Maximum observed concentration (Cmax) of BG00010
Time frame: Pre-dose and up to 24 hours post-dose
Time to maximum serum concentration (Tmax) of BG00010
Time frame: Pre-dose and up to 24 hours post-dose
Half life (t1/2) of BG00010
Time frame: Pre-dose and up to 24 hours post-dose
Area under the serum concentration time curve (AUC) from zero to infinity AUC(0-∞) for BG00010
Time frame: Pre-dose and up to 24 hours post-dose
Subcutaneous (SC) bioavailability
Time frame: Pre-dose and up to 24 hours post-dose
Number of participants with anti-BG00010 antibodies in serum
Time frame: Up to Day 75
Pain as measured by an 11-point numeric rating scale (NRS)
Time frame: Up to Day 75
Pain as measured by short form McGill pain questionnaire (SF-MPQ) visual analog scale (VAS)
Time frame: Up to Day 75
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BG00010 IV and BG00010 SC in people with Painful Lumbar Radiculopathy and Healthy, run by Biogen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs) (time frame: Up to Day 75). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.