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Lumbosacral RadiculopathyPhase 2NCT01655849

Phase 2 Efficacy Trial of Z160 in Lumbosacral Radiculopathy

A Phase 2 study testing z160 in people with Lumbosacral Radiculopathy, run by Zalicus at 23 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

This study will compare Z160 and placebo in patients with Lumbosacral Radiculopathy for safety and efficacy for a period of 6 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lumbosacral Radiculopathy
What is being tested?
z160
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
141 participants
Where
23 sitesUnited States
Study dates
Aug 2012to Nov 2013
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

  • The subject must have a diagnosis of pain due to LSR, with all of the following characteristics:
  • The subject perceives pain in one or both lower limbs at sites that are consistent with the area innervated by the L4, L5, or S1 nerve roots, with or without other sensory symptoms in the affected areas (typically, the pain may be perceived in the buttock, thigh, calf, leg, foot, or toes).
  • The history of the pain suggests that the cause of the LSR is due to injury of the lumbosacral nerve root(s) by degenerative disease of the vertebrae in the lumbosacral spine or associated soft tissues (including the intervertebral discs).
  • The duration of pain since onset is ≥ 12 weeks.
  • Based on clinical history, the intensity of pain has been stable during the 2-week period before screening.
  • In the investigator's opinion, the subject's diagnosis of LSR is supported by all of the following at screening:
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  • Based on the StEP instrument:
  • Neurological examination of lower limbs shows impaired muscle power, sensory function, or deep tendon reflexes in the territory of the affected nerve roots.
  • Pain/sensory disturbance in dermatomal/myotomal distribution is precipitated or exacerbated by straight leg raising (the straight-leg-raising test should be performed as specified in StEP).
  • The total StEP score is ≥ 4 (indicative of LSR as the cause of the pain)
  • 4. At screening, the subject has an average daily pain score for neuropathic pain due to LSR of ≥ 3 and ≤ 8 on the PI-NRS.
  • 5. If female, the subject must be postmenopausal (defined as no menstruation for at least 12 months), surgically sterilized for ≥3 months before the screening visit, or agree to use 2 reliable methods of contraception (oral, implantable, transdermal, or injectable contraceptives in conjunction with an intrauterine device or a barrier method) during the 6-week treatment period, during the 6 week posttreatment follow-up period, and for an additional 8 weeks after the last study visit (Week 12, Visit 9) to avoid pregnancy if of childbearing potential (defined as biologically capable of becoming pregnant). If male, the subject must agree to use condoms during the 6-week treatment period with the study drug, during the 6-week posttreatment follow up period, and for an additional 8 weeks after the last study visit (Week 12, Visit 9).

Who cannot join

  • The subject has:
  • Neuropathic pain due to causes other than that specified in the inclusion criteria (e.g., postherpetic neuralgia; painful diabetic neuropathy; mononeuritis multiplex; central poststroke pain; failed back surgery in relation to the presenting episode of radiculopathy; spinal abscess, infection, hematoma, or malignancy; phantom limb pain; peripheral neuropathy due to alcoholism, malignancy, human immunodeficiency virus [HIV], syphilis; drug abuse; vitamin B12 deficiency; hypothyroidism; liver disease; toxic exposure).
  • Pain that is associated with a substantial somatic pain component (e.g., non-neuropathic/musculoskeletal pain in lower limbs or other parts of the body apart from the back) or more than one cause or potential cause for pain symptoms.
  • Any painful concurrent rheumatic disease such as, but not limited to, fibromyalgia, rheumatoid arthritis, or significant osteoarthritis.
  • Any question regarding the acceptability of the etiology of the neuropathic pain should be discussed with the Zalicus medical monitor.
  • In the investigator's opinion, the subject is unable to reliably delineate or assess his or her own pain by anatomical location/distribution (e.g., the subject cannot reliably tell the difference between his or her back pain and lower limb pain and cannot rate the intensity of each separately).
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  • The subject has pain in the lower limbs solely upon walking and not at rest.
  • The subject has undergone surgery for LSR within the last 6 months or has received treatment with epidural injections, nerve blocks, or acupuncture for LSR within 4 weeks before screening.
  • The subject has:
  • A history of seizure, excluding pediatric febrile seizures, or currently has seizures
  • A history of or a current diagnosis of schizophrenia or bipolar disorder
  • Had a stroke or TIA ≤ 6 months before the screening visit
  • Has an episode of major depression or generalized anxiety disorder ≤ 6 months before the screening visit.
  • The subject has a history of or currently has any of the following conditions that, in the investigator's opinion, may interfere with the study procedures or compromise the subject's safety:
  • Cardiovascular disease
  • Gastrointestinal disease
  • Hepatic disease
  • Respiratory disease
  • Renal disease
  • Any condition that is known to interfere with the absorption, distribution, metabolism, or excretion of drugs
  • The subject has a history of or currently has:
  • Any clinically significant vital sign, ECG, or laboratory abnormalities.
  • QTcF >450 msec (males) or >470 msec (females)
  • The subject had a malignancy.
  • The subject has had a positive test for HIV antibody or a history of HIV.
  • The subject has had a positive test for hepatitis B surface antigen or hepatitis C antibody.
  • The subject has a history of AST, ALT or bilirubine >2 times the upper limit of normal.
  • The subject has a history of hypersensitivity to calcium channel blockers.
  • The subject has a history of multiple drug allergies (≥ 2 kinds) that, in the investigator's opinion, may place him or her at greater risk during participation in the study.
  • The subject has participated in a previous clinical study of Z160 or has received another investigational drug ≤ 30 days before the screening visit.
  • The subject has taken a prohibited medication ≤ 30 days before the screening visit.
  • The subject has a history of alcohol or narcotic substance abuse, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), ≤ 1 year before the screening visit.
  • The subject has a positive urine drug test at screening.
  • The subject is female and is pregnant or breastfeeding at the time of the screening visit or plans to become pregnant during the study period.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • Investigative Site

    Anaheim, California, 92804

  • Investigative Site

    Atlanta, Georgia, 30342

  • Investigative Site

    Bellevue, Washington, 98007

  • Investigative Site

    Boston, Massachusetts, 02135

  • Investigative Site

    Clearwater, Florida, 33756

  • Investigative Site

    Clearwater, Florida, 33765

  • Investigative Site

    Dallas, Texas, 75230

  • Investigative Site

    Duncansville, Pennsylvania, 16635

  • Investigative Site

    Fresno, California, 93726

  • Investigative Site

    Hazelwood, Missouri, 63042

  • Investigative Site

    Huntsville, Alabama, 35801

  • Investigative Site

    Las Vegas, Nevada, 89144

  • Investigative Site

    Medford, Oregon, 97504

  • Investigative Site

    Orange, California, 92868

  • Investigative Site

    Orlando, Florida, 32806

  • Investigative Site

    Overland Park, Kansas, 66210

  • Investigative Site

    Peoria, Arizona, 85381

  • Investigative Site

    Pinellas Park, Florida, 33781

  • Investigative Site

    Plantation, Florida, 33317

  • Investigative Site

    Royal Palm Beach, Florida, 33411

  • Investigative Site

    Sacramento, California, 95821

  • Investigative Site

    Sandy City, Utah, 84070

  • Investigative Site

    Shreveport, Louisiana, 71105

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy and Safety of Z160 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

This study will compare Z160 and placebo in patients with Lumbosacral Radiculopathy for safety and efficacy for a period of 6 weeks.

Being tested
z160, Placebo

What participants receive

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

  • z160Drug

  • PlaceboDrug

Study groups in NCT01655849
Study groupRoleWhat they receive
Z160Experimental375mg BID
Receives: Drug: z160
placeboPlacebo comparatormatching placebo control
Receives: Drug: Placebo

What is being measured

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

  1. Change in weekly average of daily pain scores (PI-NRS)

    Measured: Baseline to week 6

Secondary outcomes (14)

  1. Change in weekly average of daily pain scores (PI-NRS)

    Measured: Baseline to weeks 1,2,3,4,5, 6

  2. Galer Neuropathic Pain Scale (NPS)

    Measured: Baseline to weeks 1,2,4,6

  3. Patient Global Impression of Change (PGIC)

    Measured: Baseline to week 6

  4. Modified Roland-Morris Disability Scale (RMDQ)

    Measured: Baseline to weeks 1,2,4,6

  5. Rescue medication use

    Measured: Weeks 1,2,3,4,5,6

  6. Profile of Mood States (POMS)

    Measured: Baseline to weeks 1,2,4,6

  7. Daily Sleep Interference Scale

    Measured: Baseline to weeks 1,2,3,4,5,6

  8. Short Form 36 (SF-36)

    Measured: Baseline to week 6

  9. Safety and tolerability

    Adverse events, ECG, labs

    Measured: Baseline, weeks 1,2,3,4,5,6,7,12

  10. Relationship of plasma concentrations

    Measured: Baseline to weeks 1,2,3,4,5,6

  11. Time to a 30% reduction in average daily pain score

    Measured: Baseline to weeks 1,2,3,4,5,6

  12. Time to a 50% reduction in average daily pain score

    Measured: Baseline to weeks 1,2,3,4,5,6

  13. Subjects who have greater than or equal to a 30% reduction in average daily pain score

    Measured: Baseline to weeks 1,2,3,4,5,6

  14. Subjects who have greater than or equal to a 50% reduction in average daily pain score

    Measured: Baseline to weeks 1,2,3,4,5,6

Timeline

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

  1. First posted2 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionOct 2013
  4. Study completionNov 2013

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01655849
Sponsor's protocol ID
Z160-LSR-201
Status last verified
Dec 2013
First submitted
26 Jul 2012
Last updated
12 Dec 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing z160 in people with Lumbosacral Radiculopathy, run by Zalicus at 23 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 12 inclusion and 34 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 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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 in weekly average of daily pain scores (PI-NRS) (time frame: Baseline to week 6). 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 NCT01655849.

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 12 Dec 2013.

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