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SciaticaPhase 2NCT01917825

A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy

A Phase 2 study testing MDT-15 in people with Sciatica and Lumbosacral Radiculopathy, run by Medtronic Spinal and Biologics at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objectives of this clinical trial are to investigate the pharmacokinetics and safety of MDT-15 pellets in escalating sequential doses administered to different cohorts. Preliminary efficacy data will also be collected for assessment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sciatica, Lumbosacral Radiculopathy
What is being tested?
MDT-15
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
6 sitesUnited States
Study dates
Jul 2013to Oct 2016
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

  • Be male or female at least 18 years of age.
  • Have radiating pain toward the buttock down to the leg and/or feet, unilateral.
  • Have radiologic pathology change from L1 - S1 consistent with a disc protrusion, non-sequestered extrusion, or sequestered fragment, as evidenced by magnetic resonance imaging (MRI), that is consistent with the clinical signs and symptoms of lumbar radiculopathy. The MRI must have been performed within 2 months prior to screening or it will need to be repeated.
  • Have primary leg pain with an average NRS score equal to or greater than 5 as measured twice a day for five days in each of two weeks during screening.
  • Have failed conservative care for at least 6 weeks. The subject must have been treated non-operatively (e.g., bed rest, physical therapy, medications, TENS, and/or manipulation) for a period of at least 6 weeks.
  • Be willing to stop current anti-inflammatory therapy taken for treatment of radicular pain.
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  • Be willing and able to keep a diary that will record study-related information.
  • If sexually active female of childbearing potential, be willing to use an acceptable method of birth control during the study. Acceptable methods include oral contraceptives (the pill), IUDs, contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide. Surgical sterilization by tubal ligation or hysterectomy is acceptable. Women of child bearing potential are defined as women who are <12 months since their last menstrual cycle prior to screening and have not experienced surgical menopause.
  • Be able to understand the study and provide written informed consent.

Who cannot join

  • Have a history of lumbar surgery, including vertebroplasty and kyphoplasty.
  • Be ≤ 6 weeks after lumbar ESI or nerve block at start of screening.
  • Have current radicular pain for more than 6 months.
  • Have more than one epidural steroid injection at the affected level to be treated within the last 6 months.
  • Have demonstrated radiographic changes consistent with subject's symptoms at more than one level on the baseline MRI.
  • Have symptomatic spinal stenosis of central origin at any level based on CT myelogram or MRI.
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  • Have pain that is localized in the lower back or other sites and is a greater component of the subject's total pain than the pain in the lower leg and/or foot.
  • Have physical problems that may interfere with any study assessments.
  • Have known infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.
  • Have presence of local or systemic malignant disease or history of local or systemic malignant disease in the past 5 years (history of basal cell carcinoma will be allowed).
  • Have impaired renal function (creatinine >1.5 times upper limit of normal).
  • Have chronic impairment liver function (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >3 times upper limit of normal).
  • Have insulin-dependent diabetes or uncontrolled diabetes mellitus (glycosylated hemoglobin [HbA1c] >7%).
  • Have leukopenia (<3,500 leukocytes/uL).
  • Have current orthostatic hypotension (defined as systolic blood pressure decrease of at least 20 mmHg or a diastolic blood pressure decrease of at least 10 mmHg or an increase in heart rate by 20 beats per minute within 3 minutes of standing).
  • Have clinically significant risk for hypotension (e.g., hypotension defined as systolic reading <90 mmHg and/or diastolic <60 mmHg, hypovolemia, autonomic neuropathy, or other medical conditions affected by changes in blood pressure).
  • Any clinically significant cardiovascular condition as evidenced by physical exam, medical history and/or baseline electrocardiogram (ECG).
  • Have evidence of bradycardia as shown by heart rate of <60 beats per minute via screening ECG.
  • Have any poorly-controlled or serious medical condition, psychiatric illness, or clinically significant laboratory value that, in the opinion of the investigator, could compromise the safety of the subject or the scientific integrity of the study (e.g., uncontrolled hypertension, autoimmune disease, or clinically relevant symptoms of thyroid dysfunction).
  • Have cauda equina syndrome.
  • Have neurological deficits, as determined by the investigator, which would interfere with the assessments required by the protocol.
  • Have been previously diagnosed with peripheral neuropathy.
  • Have vascular claudication, as determined by the investigator, which would interfere with the assessments required by the protocol.
  • Have a history or evidence of bleeding disorder (e.g., hemophilia, disseminated intravascular coagulation disorder [DIC], or thrombocytopenia [TCP])
  • Have greater than 3 mm spondylolisthesis at the affected level.
  • Have BMI greater than or equal to 40, or with any anatomic issues that may interfere with placement of the MDT-15 pellets as noted by the Investigator.
  • Have a diagnosis of major depression.
  • Have sustained a vertebral or hip fracture within the last year.
  • Have known or suspected allergy or hypersensitivity to clonidine, lidocaine, contrast media, opioids, any medication that may be given as part of the site's standard of care related to the study drug implantation procedure, or any other medication that may be given as treatment during the study.
  • Have a known or suspected allergy to polylactic acid (found in products such as Lupron Depot®, Atridox®, some types of dermal fillers, and some types of sutures).
  • If female, be pregnant or breastfeeding, or desiring to become pregnant during the trial.
  • Have taken an investigational drug or used an investigational device within the past 30 days or intending to use an investigational drug or device during the trial.
  • Have active alcoholism or drug dependency, as determined by the investigator
  • Be currently on worker's compensation or in litigation related to injury or medical condition.
  • Be in circumstances which make it difficult to maintain a usual nighttime sleep schedule (e.g., the subject works on an evening/night shift or otherwise has a work or activity schedule which could confound or interfere with study assessments).
  • Have current treatment with any of the following medications:
  • Systemic corticosteroids (intranasal/inhaled steroids are acceptable).
  • Immunosuppressant therapy to treat autoimmune diseases (e.g., rheumatoid arthritis, multiple sclerosis, myasthenia gravis, systemic lupus erythematosus, sarcoidosis, focal segmental glomerulosclerosis, Crohn's disease, Behcet's Disease, pemphigus, and ulcerative colitis).
  • Oral or topical products that contain clonidine (e.g., Catapres).
  • Herbal supplements that contain yohimbine.
  • Anti-coagulant therapy (prophylactic aspirin at 81mg/day is acceptable). If applicable, aspirin therapy should be held before and after the study procedure based on the investigator's discretion.
  • Calcium channel blocker, digoxin, or beta-adrenergic blockers.
  • Have chronic use of opioids (including tramadol), defined as use 20 out of the last 30 days prior to study screening.
  • Have emotional or health concerns (in the judgment of the investigator) that may compromise the safety of the subject, may make compliance difficult, or may confound the reliability of information acquired in this study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Millennium Pain Center

    Bloomington, Illinois, 61701

  • Indiana Spine Group

    Carmel, Indiana, 46032

  • Otrimed Clinical Research

    Edgewood, Kentucky, 41017

  • Holy Cross Orthopedic Institute

    Fort Lauderdale, Florida, 33334

  • Franciscan St Francis Pain and Spine Center

    Indianapolis, Indiana, 46237

  • Pain and Rehabilitation Specialists

    St Louis, Missouri, 63017

Other trials in United States

About this study

Official title: An Open-Label, Sequential, Dose Escalation Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy

The primary objectives of this clinical trial are to investigate the pharmacokinetics and safety of MDT-15 pellets in escalating sequential doses administered to different cohorts. Preliminary efficacy data will also be collected for assessment.

Being tested
MDT-15
Keywords
radicular pain
Medical subject headings
Sciatica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDT-15Drug

Study groups in NCT01917825
Study groupRoleWhat they receive
MDT-15ExperimentalThe treatments will be administered to separate, sequential cohorts of 18 treated subjects in the following escalating doses:1 pellet, 3 pellets, and 6 pellets.
Receives: Drug: MDT-15

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.

    Measured: 84 days

  2. Tmax

    The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.

    Measured: 84 days

  3. AUC0-t

    The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.

    Measured: 84 days

  4. AUC0-∞

    The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.

    Measured: 84 days

  5. Incidence of Adverse Events

    Incidence of Adverse Events as a Measure of Safety.

    Measured: 364 days

Secondary outcomes (8)

  1. Change in Radicular Leg Pain

    Radicular leg pain measured by a 0-10 Numeric Rating Scale (NRS).

    Measured: Baseline and 364 days

  2. Change in Physical Function

    Physical Functioning measured by the Modified Roland Disability Questionnaire (RMS-L).

    Measured: Baseline and 364 days

  3. Change in Back Pain

    Back pain measured by a 0-10 Numeric Rating Scale (NRS).

    Measured: Baseline and 364 days

  4. Change in Neuropathic Type Symptoms

    Neuropathic Type Symptoms as measured by the Short-form McGill Pain Questionnaire (SF-MPQ-2).

    Measured: Baseline and 84 days

  5. Change in Medical Outcomes study - Sleep Scale

    Sleep as measured by the Medical Outcomes Study - Sleep Scale (MOS-Sleep).

    Measured: Baseline and 84 days

  6. Change in Emotional Function

    Emotional functioning as measured by the Profile of Mood States - Brief Form (POMS- Brief).

    Measured: Baseline and 84 days

  7. Change in Work Function

    Work Function as measured by the Work Limitations Questionnaire (WLQ).

    Measured: Baseline and 84 days

  8. Global Rating of Improvement

    Global rating of improvement as measured by a Patient Global Impression of Change (PGIC).

    Measured: 84 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionOct 2015
  4. Study completionOct 2016

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01917825
Sponsor's protocol ID
P12-06
Status last verified
Feb 2017
First submitted
30 Jul 2013
Last updated
20 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MDT-15 in people with Sciatica and Lumbosacral Radiculopathy, run by Medtronic Spinal and Biologics at 6 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 9 inclusion and 44 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 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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. 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?

Cmax (time frame: 84 days). The study lists 5 primary outcomes in all. 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 NCT01917825.

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 20 Apr 2017.

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