Painful Lumbar RadiculopathyPhase 2SPRINTNCT01873404
BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy
A Phase 2 study testing BG00010 in people with Painful Lumbar Radiculopathy and Sciatica, run by Biogen at 25 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Lumbar Radiculopathy, Sciatica, Radiculopathy
- What is being tested?
- BG00010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 25 sitesUnited States
- Study dates
- Jun 2013to Mar 2015
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body weight ≤133 kg.
- 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.
- Objective, documented evidence of painful lumbar radiculopathy involvement
- Lower back pain
- Leg pain
- 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.
Who cannot join
- History of or positive test result at screening for human immunodeficiency virus, or for hepatitis C virus antibody, or current Hepatitis B infection.
- Clinically significant diseases or conditions as determined by the investigator.
- Major surgery within 30 days prior to the Screening Visit or that is scheduled to occur during the study.
- Previous participation in a study with neurotrophic factors (e.g., nerve growth factor).
- Participation in a study with another investigational drug or approved therapy for investigational use within 3 months prior to Day 1.
- Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec Inc. (Biogen Idec), make the subject unsuitable for enrollment
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Research Site
Bloomington, Illinois, 61701
Research Site
Brockton, Massachusetts, 02301
Research Site
Chicago, Illinois, 60657
Research Site
Columbus, Georgia, 31904
Research Site
Duncansville, Pennsylvania, 16635
Research Site
Evansville, Indiana, 47714
Research Site
Fort Lauderdale, Florida, 33312
Research Site
Fresno, California, 93710
Research Site
Lincoln, Nebraska, 68521
Research Site
Lomita, California, 90717
Research Site
Long Beach, California, 90806
Research Site
Orlando, Florida, 32806
Research Site
Overland Park, Kansas, 66210
Research Site
Pasadena, California, 91105
Research Site
Phoenix, Arizona, 85018
Research Site
Raleigh, North Carolina, 27612
Research Site
Salt Lake City, Utah, 84106
Research Site
San Antonio, Texas, 78731
Research Site
Sarasota, Florida, 34232
Research Site
Savannah, Georgia, 31406
Research Site
St. Petersburg, Florida, 33713
Research Site
Sunrise, Florida, 33351
Research Site
Tampa, Florida, 33606
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Winter Park, Florida, 32789
About this study
Official title: 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
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.
The 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.
Read the detailed description
During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.
- Conditions
- Painful Lumbar Radiculopathy, Sciatica, Radiculopathy
- Being tested
- BG00010, Placebo
- Medical subject headings
- Sciatica, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG00010Drug
Also called Neublastin
As specified in the treatment arm
PlaceboDrug
As specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| BG00010 | Experimental | Administered as an IV injection at various dose levels 3 times per week for 1 week Receives: Drug: BG00010 |
| Placebo | Placebo comparator | Matched placebo IV injection 3 times per week for 1 week Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score
Measured: At the end of treatment period (Day 6-10)
Secondary outcomes (9)
Change from Baseline in the mean 24-hour average back pain intensity (ABPI) score
Measured: At the end of the treatment period (day 6-10)
Change from Baseline in the mean 24-hour average leg pain intensity score (ALPI)
Measured: At the end of the treatment period (day 6-10)
Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI)
Measured: Up to week 5
Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI)
Measured: Up to week 5
Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI)
Measured: Up to week 5
Maximum observed serum concentration (Cmax) of BG00010
Measured: Up to Day 5
Number of participants experiencing adverse events (AEs)
Measured: Up to week 9
Number of participants experiencing serious adverse events (SAEs)
Measured: Up to week 9
Change from Baseline in Incidence of neutralizing antibodies in serum
Measured: Up to week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2015
- Study completionMar 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 183 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
- NCT01873404
- Sponsor's protocol ID
- 103NS201
- Acronym
- SPRINT
- Status last verified
- Apr 2015
- First submitted
- 7 May 2013
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01873404
- Acronym / sponsor ID
- SPRINT / 103NS201
- Conditions
- Painful Lumbar Radiculopathy, Sciatica, Radiculopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Jun 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 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.
The 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.
Detailed description
During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BG00010 | Experimental | Drug: BG00010Administered as an IV injection at various dose levels 3 times per week for 1 week |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo IV injection 3 times per week for 1 week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body weight ≤133 kg.
- 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.
- Objective, documented evidence of painful lumbar radiculopathy involvement
- Lower back pain
- Leg pain
Key exclusion criteria (7 listed)
- History of or positive test result at screening for human immunodeficiency virus, or for hepatitis C virus antibody, or current Hepatitis B infection.
- Clinically significant diseases or conditions as determined by the investigator.
- Major surgery within 30 days prior to the Screening Visit or that is scheduled to occur during the study.
- Previous participation in a study with neurotrophic factors (e.g., nerve growth factor).
- Participation in a study with another investigational drug or approved therapy for investigational use within 3 months prior to Day 1.
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 |
|---|---|---|
| BG00010Also: NeublastinAs specified in the treatment arm | Drug | BG00010 |
| PlaceboAs specified in the treatment arm | Drug | Placebo |
Primary outcome
Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score
Time frame: At the end of treatment period (Day 6-10)
9 secondary outcomes
Change from Baseline in the mean 24-hour average back pain intensity (ABPI) score
Time frame: At the end of the treatment period (day 6-10)
Change from Baseline in the mean 24-hour average leg pain intensity score (ALPI)
Time frame: At the end of the treatment period (day 6-10)
Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI)
Time frame: Up to week 5
Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI)
Time frame: Up to week 5
Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI)
Time frame: Up to week 5
Maximum observed serum concentration (Cmax) of BG00010
Time frame: Up to Day 5
Number of participants experiencing adverse events (AEs)
Time frame: Up to week 9
Number of participants experiencing serious adverse events (SAEs)
Time frame: Up to week 9
Change from Baseline in Incidence of neutralizing antibodies in serum
Time frame: Up to week 9
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 10 Sep 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
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BG00010 in people with Painful Lumbar Radiculopathy and Sciatica, run by Biogen at 25 sites in United States.
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 6 inclusion and 7 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 10 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score (time frame: At the end of treatment period (Day 6-10)). 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 10 Sep 2015.