Lumbosacral RadiculopathyPhase 2NCT01561027
Crossover Study of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
A Phase 2 study testing CNV1014802 in people with Lumbosacral Radiculopathy, run by Biogen at 12 sites in 4 countries.
Trial summary
The study is a randomized, double blind, cross-over study to evaluate the safety and efficacy of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- CNV1014802
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 30 Apr 2011to 31 Aug 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged between 18 and 65 years, with a diagnosis of neuropathic pain due to lumbosacral radiculopathy (LSR).
- Female subjects must be of non-child bearing potential or agree to use an approved form of contraception
- Body weight < 50 kg for men and < 45 kg for women.
- Capable of giving written informed consent.
- Approved concomitant medications must have been stable for at least 4 weeks prior to day 1.
- Average baseline daily pain score for neuropathic pain due to LSR on the 11-point numerical rating scale of 4 or greater.
Who cannot join
- Subjects who are unable to reliably delineate or assess their own pain by anatomical location/distribution.
- Subjects with lumbar canal stenosis in which the pain in the lower limbs occur solely on walking and not at rest.
- Subjects with causes for their neuropathic pain other than LSR.
- Subjects who have received nerve blocks and/or steroid injections for neuropathic pain within 4 weeks prior to day 1.
- Subjects who are indicated for surgical treatment of lumbosacral radiculopathy.
- A positive pre-study drug screen.
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- A positive history of HIV.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- History of any liver disease within the last 6 months, with the exception of known Gilbert's disease.
- History of excessive regular alcohol consumption within 6 months of the study.
- Subjects with a history or risk of seizures or a history of epilepsy, head injury or related neurological disorders
- Subjects with a history of uncontrolled or poorly controlled hypertension, with systolic BP frequently exceeding 160mmHg and/or diastolic BP frequently exceeding 100mmHg, or subjects who have BP greater than or equal to 160mmHg systolic and/or greater than or equal to 100mmHg diastolic at screening after repeated measurements
- History or presence of significant cardiovascular, gastro-intestinal, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Subjects with conditions known to affect cardiac conduction or a personal or familial history of Brugada syndrome
- Pregnant females or lactating females.
- History or presence of any clinically significant abnormality in vital signs / ECG / laboratory tests or have any medical or psychiatric condition, which, in the opinion of the Investigator may interfere with the study procedures or compromise subject safety.
- History of suicidal ideation and/or suicide attempts or clinical evidence of recent major depression.
- Subjects who are unable to maintain their same medications for the treatment of neuropathic pain at a stable dose during the study.
- Unable to refrain from excessive use of sedatives.
- Unable to comply with the prohibited concomitant medication restrictions as detailed in the protocol. This includes but is not limited to sodium channel blockers or drugs that adversely interact with a monoamine oxidase-B inhibitor: MAOI's, antidepressants, opioids and sympathomimetic agents.
- Unable to stop and remain abstained from non-pharmacological treatments for their neuropathic pain during the study.
- History of hypersensitivity to CNV1014802.
- The subject has participated in a clinical trial and has received an investigational product within 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to the start of this study.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Subject is mentally or legally incapacitated.
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
France4 sites
Research Site
Lille
Research Site
Nice
Research Site
Paris
Research Site
Saint-Etienne
Czechia3 sites
Research Site
Brno
Research Site
Litoměřice
Research Site
Prachatice
Sweden3 sites
Research Site
Gothenburg
Research Site
Malmö
Research Site
Stockholm
About this study
Official title: A Randomized, Double Blind, Cross-over Study to Evaluate the Safety and Efficacy of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
The study is a randomized, double blind, cross-over study to evaluate the safety and efficacy of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy.
Read the detailed description
The study consists of two treatment periods of 22 days with randomized CNV1014802 350mg or placebo administered twice daily. In addition, single blind placebo will be administered during a two week run-in, a two week wash-out period between the two treatment periods, and a one week run-out phase.
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- CNV1014802, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNV1014802Drug
Administered as specified in treatment arm.
PlaceboDrug
Administered as specified in treatment arm
| Study group | Role | What they receive |
|---|---|---|
| CNV1014802 | Experimental | CNV1014802 350mg on prescription (BID) for 21 days Receives: Drug: CNV1014802 |
| Placebo | Placebo comparator | Placebo 350mg BID for 21 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Daily Neuropathic Pain Score from Baseline
Change in average daily neuropathic pain score from baseline (average days 10-14) to week 3 based on the 11 point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=maximum pain imaginable).
Subjects should specifically rate the pain intensity for the neuropathic pain associated with lumbosacral radiculopathy and not pain from other concomitant causes
Measured: Three weeks
Secondary outcomes (6)
Numerical Pain Rating Scale
Change in average daily pain score from baseline (average days 10-14) to week 1 and week 2 of treatment and 1 week following the end of randomized treatment.
Measured: 3 weeks
Responder Rate
Proportion of patients who have >= 30% and >=50% reduction in average daily pain score relative to baseline during weeks 1, 2 and 3 of treatment and 1 week following the end of randomized treatment.
Measured: 3 weeks
Galer Neuropathic Pain Scale
Change in Galer Neuropathic Pain Scale from baseline to week 3 of treatment.
Measured: 3 weeks
Oswestry Disability Index
Change in average disability score from baseline to week 1, week 2 and week 3 of treatment based on Oswestry Disability Index
Measured: 3 weeks
PGIC
Proportion of patients who have "improved", "much improved" or "very much improved" relative to baseline on the Patient Global Impression of Change (PGIC) on week 3 of treatment.
Measured: 3 weeks
CGIC
Proportion of patients who have "improved", "much improved" or "very much improved" relative to baseline on the Clinical Global Impression of Change (CGIC) on week 3 of treatment.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study start30 Apr 2011
- Primary completion30 Jun 2012
- Study completion31 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 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
- NCT01561027
- Sponsor's protocol ID
- CNV1014802/201
- Status last verified
- Oct 2017
- First submitted
- 19 Mar 2012
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Cross-over Study to Evaluate the Safety and Efficacy of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
- ClinicalTrials.gov ID
- NCT01561027
- Acronym / sponsor ID
- CNV1014802/201
- Conditions
- Lumbosacral Radiculopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2011 (actual)
- Primary completion
- 30 Jun 2012 (actual)
- Study completion
- 31 Aug 2012 (actual)
- First posted
- 22 Mar 2012 (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 study is a randomized, double blind, cross-over study to evaluate the safety and efficacy of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy.
Detailed description
The study consists of two treatment periods of 22 days with randomized CNV1014802 350mg or placebo administered twice daily. In addition, single blind placebo will be administered during a two week run-in, a two week wash-out period between the two treatment periods, and a one week run-out phase.
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CNV1014802 | Experimental | Drug: CNV1014802CNV1014802 350mg on prescription (BID) for 21 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 350mg BID for 21 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged between 18 and 65 years, with a diagnosis of neuropathic pain due to lumbosacral radiculopathy (LSR).
- Female subjects must be of non-child bearing potential or agree to use an approved form of contraception
- Body weight < 50 kg for men and < 45 kg for women.
- Capable of giving written informed consent.
- Approved concomitant medications must have been stable for at least 4 weeks prior to day 1.
Key exclusion criteria (27 listed)
- Subjects who are unable to reliably delineate or assess their own pain by anatomical location/distribution.
- Subjects with lumbar canal stenosis in which the pain in the lower limbs occur solely on walking and not at rest.
- Subjects with causes for their neuropathic pain other than LSR.
- Subjects who have received nerve blocks and/or steroid injections for neuropathic pain within 4 weeks prior to day 1.
- Subjects who are indicated for surgical treatment of lumbosacral radiculopathy.
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 |
|---|---|---|
| CNV1014802Administered as specified in treatment arm. | Drug | CNV1014802 |
| PlaceboAdministered as specified in treatment arm | Drug | Placebo |
Primary outcome
Change in Average Daily Neuropathic Pain Score from Baseline
Time frame: Three weeks
Change in average daily neuropathic pain score from baseline (average days 10-14) to week 3 based on the 11 point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=maximum pain imaginable). Subjects should specifically rate the pain intensity for the neuropathic pain associated with lumbosacral radiculopathy and not pain from other concomitant causes
6 secondary outcomes
Numerical Pain Rating Scale
Time frame: 3 weeks
Responder Rate
Time frame: 3 weeks
Galer Neuropathic Pain Scale
Time frame: 3 weeks
Oswestry Disability Index
Time frame: 3 weeks
PGIC
Time frame: 3 weeks
CGIC
Time frame: 3 weeks
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 13 Oct 2017.
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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
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CNV1014802 in people with Lumbosacral Radiculopathy, run by Biogen at 12 sites in 4 countries.
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 27 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 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Czechia, Sweden, Denmark. 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 in Average Daily Neuropathic Pain Score from Baseline (time frame: Three weeks). 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 13 Oct 2017; AzTrials last refreshed its copy on 8 Nov 2026.