Radicular Pain Related to Lumbosacral Disc DiseasePhase 4NCT01777581
Milnacipran for Lumbosacral Radicular Pain
A Phase 4 study testing Milnacipran in people with Radicular Pain Related to Lumbosacral Disc Disease, run by Duke University.
Trial summary
This study investigates whether milnacipran reduces radicular pain ("sciatica") in patients with lumbosacral disc disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radicular Pain Related to Lumbosacral Disc Disease
- What is being tested?
- Milnacipran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Oct 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject is a male or female adult outpatient age 18 or older at the time of consent.
- Subject experiences chronic (> 6 months) radicular pain at least 5 days a week described as sharp or shooting below the level of the knee associated with lumbar or sacral disk disease without suspicion of recent injury; remote (>1 year ago) history of surgical intervention (e.g. "failed back syndrome") is allowed provided current symptoms meet severity criterion.
- Subject-rated VAS specifically related to radicular pain > or = 40 mm at screen and baseline visits
- Subject has an understanding, ability and willingness to fully comply with study procedures and restrictions.
- Subject has the ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
Who cannot join
- Subjects unable to complete assessments due to language or cognitive impairment
- Subjects treated with antidepressant or anticonvulsant medication within 4 weeks of screening visit (6 weeks for fluoxetine).
- Subjects taking monoamine oxidase inhibitors
- Subjects who have received procedural intervention within 3 months of screen.
- Subjects with known sensitivity to milnacipran.
- Subjects unable to complete the questionnaires due to language or cognitive impairment.
Show all 21Show fewer
- Subjects with a history of bipolar disorder or psychosis as confirmed by the Mini International Neuropsychiatric Interview (MINI).
- Subject currently has (or had a history within the last 6 months of) a drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual for Mental Disorders, Text Revision criteria (excluding nicotine).
- Subjects who are currently considered a suicide risk, any subject who has previously made a suicide attempt or who has a prior history of or are currently demonstrating active suicidal ideation.
- Subject has any clinically significant electrocardiogram (ECG) or clinically significant laboratory abnormality (including a positive urine drug screen) at Screening.
- Subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol.
- Subjects who are pregnant or who are nursing
- Subjects who do not agree to use adequate and reliable contraception throughout the study.
- Subject previously completed, discontinued or was withdrawn from this study.
- Subject has taken an investigational drug or taken part in a clinical trial within 30 days prior to Screening.
- Subjects with liver disease or reduced liver function
- Subjects with obstructive uropathies
- Subjects who consume alcohol in amounts viewed by the Investigator to be contraindicated
- Subjects with uncontrolled narrow angle glaucoma
- Subjects with seizure disorders
- Subjects with bleeding disorders or use of other medications that may cause bleeding
About this study
Official title: A Ten-Week, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of Milnacipran for Radicular Pain Associated With Lumbosacral Disk Disease
This study investigates whether milnacipran reduces radicular pain ("sciatica") in patients with lumbosacral disc disease.
Read the detailed description
The current study evaluates the potential efficacy of milnacipran in reducing lower extremity radicular pain associated with lumbar disk disease. Milnacipran will be titrated based on efficacy and tolerability aimed at the higher end of the therapeutic range; a recent study of a serotonin norepinephrine reuptake inhibitor in patients with osteoarthritis pain suggests efficacy may be dose related. Patients are likely to have concomitant nociceptive lower back pain, and cotreatment with opioids, muscle relaxants, benzodiazepines, or nonsteroidal anti-inflammatory drugs at stable doses will be permitted. Patients participating in stable regimen of physical therapy or biofeedback will be eligible. Procedural interventions (e.g. epidural steroid injection, nerve block, facet radioablation, acupuncture) during the study and 3 months prior will be exclusionary. Anticonvulsants, tramadol, and other antidepressant drugs will be excluded.
The study is a ten-week randomized, double-blind, placebo-controlled trial (RCT) of milnacipran (100-200 mg/day dosed twice a day) for radicular pain associated with lumbosacral disk disease.
Outcome measures and safety assessments will be obtained at weeks 1, 2, 4, 6, 8, and 10 according to the protocol schedule of assessments.
- Being tested
- Milnacipran, Placebo
- Keywords
- sciatica radiculopathy lumbar disc lumbosacral disc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilnacipranDrug
Also called Savella
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| milnacipran | Experimental | Milnacipran, flexibly dosed Receives: Drug: Milnacipran |
| Sugar pill (placebo) | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad)
The primary outcome is change in pain VAS from baseline through 10 weeks. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative total scores were reported.
Measured: baseline and 10 weeks
Secondary outcomes (6)
VAS Related to Nociceptive Pain Component (VAS-Noc)
The secondary outcome is change in pain VAS from baseline through 1o weeks as related to nociceptive pain component. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative scores were reported
Measured: baseline and 10 weeks
SF-36 (Short Form)
Self-report of quality of life. Subjective measure of perceived quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Scoring: Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Higher scores reflect higher quality of life with 100 high life quality. Total mean cumulative scores were reported
The eight sections are:
vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health
Measured: baseline and 10 weeks
Oswestry Low Back Pain Disability Questionnaire
Self report evaluation of various back pain symptoms. For each of 10 sections participants rate pain on a scale of 0-5 in these categories:
- Section 1 - Pain intensity
- Section 2 - Personal care
- Section 3 - Lifting
- Section 4 - Walking
- Section 5 - Sitting
- Section 6 - Standing
- Section 7 - Sleeping
- Section 8 - Sex life (if applicable)
- Section 9 - Social life
- Section 10 - Travelling
The scores are combined form each category into overall score. Scores are converted to percentages as follows:
0% to 20%: minimal disability: The patient can cope with most living activities.
21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing.
41%-60%: severe disability: Pain remains the main problem-activities of daily living are affected.
61%-80%: crippled: Back pain impinges on all aspects of life.
81%-100%: Patients are either bed-bound or exaggerating their symptoms
Measured: baseline and 10 weeks
Neuropathic Pain Questionnaire
Self-report evaluation of nerve pain symptoms. A low total cumulative score means less pain and higher cumulative score is greater pain.
Total cumulative scores range form 0 to 1000 where in 0 is absence of pain and 1000 highest pain.
Measured: baseline and 10 weeks
Beck Depression Inventory (BDI-II)
Self-report evaluation of depressive symptoms.The secondary outcome measure is change in Beck Depression Inventory. The scale for this inventory is:
0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. The higher the score the degree of depression.
Measured: baseline and 10 weeks
State-trait Anxiety Inventory (STAI)
Self-report evaluation of anxiety symptoms.Assessment of subjective symptoms of current anxiety and chronic anxiety.
There are 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale
Scale
1= almost never 4= almost always
Higher scores indicate greater anxiety. Mean cumulative scores were reported
Measured: baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radicular Pain Related to Lumbosacral Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777581
- Sponsor's protocol ID
- Pro00020888
- Other IDs
- SAV-MD-12
- Status last verified
- Apr 2014
- First submitted
- 30 Nov 2012
- Last updated
- 23 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Marks DM, Pae CU, Patkar AA. A double-blind, placebo-controlled, parallel-group pilot study of milnacipran for chronic radicular pain (sciatica) associated with lumbosacral disc disease. Prim Care Companion CNS Disord. 2014 Aug 14;16(4):10.4088/PCC.14m01658. doi: 10.4088/PCC.14m01658. eCollection 2014.
PubMed 25664215
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Ten-Week, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of Milnacipran for Radicular Pain Associated With Lumbosacral Disk Disease
- ClinicalTrials.gov ID
- NCT01777581
- Acronym / sponsor ID
- Pro00020888
- Keywords
- sciatica radiculopathy lumbar disc lumbosacral disc
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Posted 23 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether milnacipran reduces radicular pain ("sciatica") in patients with lumbosacral disc disease.
Detailed description
The current study evaluates the potential efficacy of milnacipran in reducing lower extremity radicular pain associated with lumbar disk disease. Milnacipran will be titrated based on efficacy and tolerability aimed at the higher end of the therapeutic range; a recent study of a serotonin norepinephrine reuptake inhibitor in patients with osteoarthritis pain suggests efficacy may be dose related. Patients are likely to have concomitant nociceptive lower back pain, and cotreatment with opioids, muscle relaxants, benzodiazepines, or nonsteroidal anti-inflammatory drugs at stable doses will be permitted. Patients participating in stable regimen of physical therapy or biofeedback will be eligible. Procedural interventions (e.g. epidural steroid injection, nerve block, facet radioablation, acupuncture) during the study and 3 months prior will be exclusionary. Anticonvulsants, tramadol, and other antidepressant drugs will be excluded.
The study is a ten-week randomized, double-blind, placebo-controlled trial (RCT) of milnacipran (100-200 mg/day dosed twice a day) for radicular pain associated with lumbosacral disk disease.
Outcome measures and safety assessments will be obtained at weeks 1, 2, 4, 6, 8, and 10 according to the protocol schedule of assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| milnacipran | Experimental | Drug: MilnacipranMilnacipran, flexibly dosed |
| Sugar pill (placebo) | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is a male or female adult outpatient age 18 or older at the time of consent.
- Subject experiences chronic (> 6 months) radicular pain at least 5 days a week described as sharp or shooting below the level of the knee associated with lumbar or sacral disk disease without suspicion of recent injury; remote (>1 year ago) history of surgical intervention (e.g. "failed back syndrome") is allowed provided current symptoms meet severity criterion.
- Subject-rated VAS specifically related to radicular pain > or = 40 mm at screen and baseline visits
- Subject has an understanding, ability and willingness to fully comply with study procedures and restrictions.
- Subject has the ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
Key exclusion criteria (21 listed)
- Subjects unable to complete assessments due to language or cognitive impairment
- Subjects treated with antidepressant or anticonvulsant medication within 4 weeks of screening visit (6 weeks for fluoxetine).
- Subjects taking monoamine oxidase inhibitors
- Subjects who have received procedural intervention within 3 months of screen.
- Subjects with known sensitivity to milnacipran.
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 |
|---|---|---|
| MilnacipranAlso: Savella | Drug | milnacipran |
| Placebo | Drug | Sugar pill (placebo) |
Primary outcome
Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad)
Time frame: baseline and 10 weeks
The primary outcome is change in pain VAS from baseline through 10 weeks. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative total scores were reported.
6 secondary outcomes
VAS Related to Nociceptive Pain Component (VAS-Noc)
Time frame: baseline and 10 weeks
SF-36 (Short Form)
Time frame: baseline and 10 weeks
Oswestry Low Back Pain Disability Questionnaire
Time frame: baseline and 10 weeks
Neuropathic Pain Questionnaire
Time frame: baseline and 10 weeks
Beck Depression Inventory (BDI-II)
Time frame: baseline and 10 weeks
State-trait Anxiety Inventory (STAI)
Time frame: baseline and 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25664215Marks DM, Pae CU, Patkar AA. A double-blind, placebo-controlled, parallel-group pilot study of milnacipran for chronic radicular pain (sciatica) associated with lumbosacral disc disease. Prim Care Companion CNS Disord. 2014 Aug 14;16(4):10.4088/PCC.14m01658. doi: 10.4088/PCC.14m01658. eCollection 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Milnacipran in people with Radicular Pain Related to Lumbosacral Disc Disease, run by Duke University.
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 5 inclusion and 21 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 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad) (time frame: baseline and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01777581, which also lists 1 linked publication.
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 23 Jul 2014.