RadiculopathyPhase 1LMRNCT02644421
Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 in Lumbar Radiculopathy (Sciatica)
A Phase 1 study testing VVZ-149 and Lidocaine in people with Radiculopathy and Sciatica, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Double-blind, crossover, randomized, 3x3 Latin square, placebo-controlled study of single intravenous dose administration of VVZ-149. To demonstrate assay sensitivity, lidocaine will be administered as a positive control. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiculopathy, Sciatica
- What is being tested?
- VVZ-149 and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jul 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have a history of persistent pain secondary to unilateral monoradiculopathy present for a minimum of 3 months prior to the study, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.
- Males or females between 18 and 70 years of age, inclusive. Females who are pregnant or breastfeeding will be excluded from the trial.
- Subjects must be in generally good health, either using no medication or using a stabilized medication regimen for chronic and well-controlled conditions such as hypertension, allergies, stable endocrinopathies (e.g. hypothyroidism), etc. Subjects with other active diseases will be reviewed on a case-by-case basis by the principal investigator.
- No concomitant therapy with any medication that is a known significant inhibitor or inducer of CYP450 2D6 and CYP3A4, at the discretion of the PI.
- Normal or clinically insignificant screening laboratory tests:
- Serum BUN, creatinine, bicarbonate, calcium, chloride, potassium, sodium, lactate dehydrogenase, inorganic phosphate, total protein, glucose, albumin, and uric acid. WBC, absolute neutrophil count, hemoglobin, hematocrit, and platelets. SGOT (AST), SGPT (ALT), total bilirubin, alkaline phosphatase, TSH/T4, urinalysis, and urine toxicology screen.
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- Electrocardiogram (12-lead). Any significant laboratory abnormalities will be reviewed by the principal investigator prior to inclusion of the subject in the study.
- Willingness to restrict analgesic therapy during inpatient admission days to the allowed rescue analgesic agent permitted by the study (acetaminophen).
- Subjects must have normal cognitive function and communicative ability in the English language.
- Subjects must be able to provide meaningful written informed consent.
- Subjects must be able to maintain complete required questionnaires, and must be able to fulfill all other conditions of the protocol.
Who cannot join
- Female subjects who are pregnant or breastfeeding, or plan to become pregnant while participating in the study.
- Subjects with a previous history of multiple or severe drug allergies, including lidocaine.
- Subjects with a history of or current chronic substance abuse, including alcohol.
- Subjects who have participated in a study of an investigational drug or device within 30 days prior to screening for this study. Subjects must agree not to participate in other investigational drug or device studies during the entire course of this study (beginning with the screening visit).
- Subjects with the following abnormal clinical evaluations:
- Impaired renal function defined as BUN > 45 or creatinine >2.0 and/or impaired liver function defined as liver transaminases, alkaline phosphatase, or bilirubin greater than 1.5 x upper limit of normal laboratory values.
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- Prolonged PR (>200 ms) interval on electrocardiogram (12-lead). Subjects presenting with the above laboratory abnormalities may be allowed on a case-by-case basis at the discretion of the principal investigator.
- Subjects who intend to donate blood or blood products while participating in this study, and for 30 days following completion of the study.
- Subjects with clinically significant renal, hepatic, or cardiac disease, with seizure disorders, or with a clinical history of life-threatening arrhythmias (i.e. torsades de pointes).
- Subjects with a severe neuropsychiatric disorder requiring treatment.
- Subjects with sensitivity to amide-type local anesthetics.
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Pain Research, Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Phase Ib Randomized, Double-Blind, Latin Square Crossover, Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 v. Lidocaine v. Placebo in Lumbar Radiculopathy
Double-blind, crossover, randomized, 3x3 Latin square, placebo-controlled study of single intravenous dose administration of VVZ-149. To demonstrate assay sensitivity, lidocaine will be administered as a positive control. The study will take place during a single inpatient visit involving three separate treatment periods, each with a washout of (>16-hours. Study drugs (VVZ-149 vs. lidocaine vs. normal saline, NS) will be administered intravenously.
- Conditions
- Radiculopathy, Sciatica
- Being tested
- VVZ-149, Lidocaine, Placebo
- Keywords
- Neuropathic Pain, Sciatica
- Medical subject headings
- Radiculopathy, Sciatica, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VVZ-149Drug
LidocaineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| VVZ-149 | Experimental | The following doses will be administered intravenously:
* Loading Dose: 1.8 mg/kg VVZ-149 over 0.5 hours
* Maintenance infusion: 1.3 mg/kg/hr VVZ-149 over 7.5 hours Receives: Drug: VVZ-149 |
| Lidocaine | Active comparator | The following doses will be administered intravenously:
* Lidocaine 4mg/kg LBM over 0.5 hours
* Normal saline over 7.5 hours Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | Normal saline administered intravenously over 8 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with treatment-related Adverse Events as assessed using an internal, categorical severity/relationship scale
The number of subjects who report mild, moderate or severe treatment-emergent adverse events that are deemed by the investigator to be possibly, probably, or definitely related to the study medication
Measured: over 8 hour infusion
Secondary outcomes (1)
Reduction in Pain Intensity using the 11-pt Likert Pain Intensity Scale
Reductions in pain intensity from baseline will be calculated using data obtained over the 8 hour infusion from the 11-pt Likert Pain Intensity Scale
Measured: over 8 hour infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine N. Sang, MD, MPH, Brigham and Women's Hospital
- Investigators
- Christine N Sang, MD MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644421
- Sponsor's protocol ID
- 2015-P-002050
- Acronym
- LMR
- Status last verified
- Mar 2018
- First submitted
- 8 Dec 2015
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Randomized, Double-Blind, Latin Square Crossover, Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 v. Lidocaine v. Placebo in Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT02644421
- Acronym / sponsor ID
- LMR / 2015-P-002050
- Conditions
- Radiculopathy, Sciatica
- Keywords
- Neuropathic Pain, Sciatica
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 31 Dec 2015 (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.
Double-blind, crossover, randomized, 3x3 Latin square, placebo-controlled study of single intravenous dose administration of VVZ-149. To demonstrate assay sensitivity, lidocaine will be administered as a positive control. The study will take place during a single inpatient visit involving three separate treatment periods, each with a washout of (>16-hours. Study drugs (VVZ-149 vs. lidocaine vs. normal saline, NS) will be administered intravenously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VVZ-149 | Experimental | Drug: VVZ-149The following doses will be administered intravenously: * Loading Dose: 1.8 mg/kg VVZ-149 over 0.5 hours * Maintenance infusion: 1.3 mg/kg/hr VVZ-149 over 7.5 hours |
| Lidocaine | Active comparator | Drug: LidocaineThe following doses will be administered intravenously: * Lidocaine 4mg/kg LBM over 0.5 hours * Normal saline over 7.5 hours |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline administered intravenously over 8 hours |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must have a history of persistent pain secondary to unilateral monoradiculopathy present for a minimum of 3 months prior to the study, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.
- Males or females between 18 and 70 years of age, inclusive. Females who are pregnant or breastfeeding will be excluded from the trial.
- Subjects must be in generally good health, either using no medication or using a stabilized medication regimen for chronic and well-controlled conditions such as hypertension, allergies, stable endocrinopathies (e.g. hypothyroidism), etc. Subjects with other active diseases will be reviewed on a case-by-case basis by the principal investigator.
- No concomitant therapy with any medication that is a known significant inhibitor or inducer of CYP450 2D6 and CYP3A4, at the discretion of the PI.
- Normal or clinically insignificant screening laboratory tests:
Key exclusion criteria (11 listed)
- Female subjects who are pregnant or breastfeeding, or plan to become pregnant while participating in the study.
- Subjects with a previous history of multiple or severe drug allergies, including lidocaine.
- Subjects with a history of or current chronic substance abuse, including alcohol.
- Subjects who have participated in a study of an investigational drug or device within 30 days prior to screening for this study. Subjects must agree not to participate in other investigational drug or device studies during the entire course of this study (beginning with the screening visit).
- Subjects with the following abnormal clinical evaluations:
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 |
|---|---|---|
| VVZ-149 | Drug | VVZ-149 |
| Lidocaine | Drug | Lidocaine |
| Placebo | Drug | Placebo |
Primary outcome
Number of subjects with treatment-related Adverse Events as assessed using an internal, categorical severity/relationship scale
Time frame: over 8 hour infusion
The number of subjects who report mild, moderate or severe treatment-emergent adverse events that are deemed by the investigator to be possibly, probably, or definitely related to the study medication
1 secondary outcome
Reduction in Pain Intensity using the 11-pt Likert Pain Intensity Scale
Time frame: over 8 hour infusion
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 19 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Christine N Sang, MD MPH principal investigator
Brigham and Women's Hospital
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 VVZ-149 and Lidocaine in people with Radiculopathy and Sciatica, run by Brigham and Women's Hospital at 1 site 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 11 inclusion and 11 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 19 Mar 2018. 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 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 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 subjects with treatment-related Adverse Events as assessed using an internal, categorical severity/relationship scale (time frame: over 8 hour infusion). 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 19 Mar 2018.