SciaticaPhase 1NCT01405833
Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.
A Phase 1 study testing BG00010 (Neublastin) in people with Sciatica, run by Biogen at 1 site in Netherlands.
Trial summary
The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sciatica
- What is being tested?
- BG00010 (Neublastin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2011to Sep 2012
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a diagnosis of unilateral sciatica, determined by the Investigator and as outlined in the protocol. Sciatica symptoms must be present for 3 or more months prior to the Screening Visit.
- 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.
Who cannot join
- History of malignancy or clinically relevant allergies and/or cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to sciatica), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
- History of severe pain as judged by the Investigator, other than that caused by sciatica during the 3 months prior to Screening Visit.
- Signs or symptoms of peripheral neuropathy, other than symptoms of sciatica during the 3 months prior to Screening Visit.
- Current generalized myalgia
- Serum creatinine >1.5 x upper limit of normal (ULN).
- History of or positive screening test for hepatitis C infection, hepatitis B infection and/or positive for hepatitis B core antibody or positive for human immunodeficiency virus (HIV) antibody. Subjects who are HBsAg negative and HBcAb positive are allowed to participate if they are positive for HBsAb IgG (see the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel).
- Treatment with any prescription medication and/or over the-counter products such as herbal supplements, unless the dose has been stable for 2 weeks prior to the Baseline Visit.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1: A Multi-Centered, Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of BG00010 (Neublastin) in Subjects With Sciatica
The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week).
Secondary objectives of this study in this study population are to explore the repeated-dose immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following multiple-dose administration.
- Conditions
- Sciatica
- Being tested
- BG00010 (Neublastin), Placebo
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG00010 (Neublastin)Drug
Multiple doses, weight-based IV administration
PlaceboDrug
Single dose IV matched placebo
| Study group | Role | What they receive |
|---|---|---|
| BG00010 (Neublastin) | Experimental | Participants may be randomized to escalating doses of BG00010 Receives: Drug: BG00010 (Neublastin) |
| Placebo | Placebo comparator | Participants may be randomised to a matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants experiencing Adverse Events
Measured: Throughout the study period- an expected 15 weeks
Serum drug concentrations of BG00010 as a measure of pharmacokinetics
Measured: Throughout the study period- an expected 15 weeks
Secondary outcomes (3)
Presence of anti-BG00010 antibodies in serum
Assessment of study-treatment-specific safety of BG00010
Measured: Throughout the study period- an expected 15 weeks
Change in pain as measured by Likert numerical pain rating scale
Measured: Every day for 3 consecutive days prior to baseline throughout the study period
Change in Visual analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)
Measured: Throughout the study period at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies 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
- 56 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
- NCT01405833
- Sponsor's protocol ID
- 103NS102
- Status last verified
- Sep 2014
- First submitted
- 21 Jul 2011
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1: A Multi-Centered, Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of BG00010 (Neublastin) in Subjects With Sciatica
- ClinicalTrials.gov ID
- NCT01405833
- Acronym / sponsor ID
- 103NS102
- Conditions
- Sciatica
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Jul 2011 (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, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week).
Secondary objectives of this study in this study population are to explore the repeated-dose immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following multiple-dose administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BG00010 (Neublastin) | Experimental | Drug: BG00010 (Neublastin)Participants may be randomized to escalating doses of BG00010 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants may be randomised to a matching placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have a diagnosis of unilateral sciatica, determined by the Investigator and as outlined in the protocol. Sciatica symptoms must be present for 3 or more months prior to the Screening Visit.
- 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 exclusion criteria (8 listed)
- History of malignancy or clinically relevant allergies and/or cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to sciatica), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
- History of severe pain as judged by the Investigator, other than that caused by sciatica during the 3 months prior to Screening Visit.
- Signs or symptoms of peripheral neuropathy, other than symptoms of sciatica during the 3 months prior to Screening Visit.
- Current generalized myalgia
- Serum creatinine >1.5 x upper limit of normal (ULN).
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 (Neublastin)Multiple doses, weight-based IV administration | Drug | BG00010 (Neublastin) |
| PlaceboSingle dose IV matched placebo | Drug | Placebo |
Primary outcome
Number of Participants experiencing Adverse Events
Time frame: Throughout the study period- an expected 15 weeks
Serum drug concentrations of BG00010 as a measure of pharmacokinetics
Time frame: Throughout the study period- an expected 15 weeks
3 secondary outcomes
Presence of anti-BG00010 antibodies in serum
Time frame: Throughout the study period- an expected 15 weeks
Change in pain as measured by Likert numerical pain rating scale
Time frame: Every day for 3 consecutive days prior to baseline throughout the study period
Change in Visual analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: Throughout the study period at each visit
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 Sep 2014.
Related trials for Sciatica
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
RecruitingPhase 1
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radicular Pain, Sciatic Radiculopathy
Recruiting
Effect of Sensorimotor Training on Pain and Gait Performance in Patients With Discogenic Sciatica
Sciatica Due to Intervertebral Disc Disorder
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
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 (Neublastin) in people with Sciatica, 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 2 inclusion and 8 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 Sep 2014. 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. Some participants in this study may receive a placebo. 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?
Number of Participants experiencing Adverse Events (time frame: Throughout the study period- an expected 15 weeks). The study lists 2 primary outcomes in all. 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 Sep 2014.