SciaticaPhase 1/2NCT01240876

Study to Evaluate the Safety and Efficacy of Placulumab (CEP-37247) Administered by the Transforaminal Epidural Route for the Treatment of Patients With Lumbosacral Radicular Pain Associated With Disk Herniation

A Phase 1/2 study testing CEP-37247 in people with Sciatica, run by Cephalon at 24 sites in 2 countries.

Completed

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

Trial summary

The primary objective of the study is to evaluate the safety and efficacy of CEP-37247 compared with placebo as assessed by the occurrence of adverse events, and the mean change in average pain intensity (API) in the affected leg. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Sciatica
What is being tested?: CEP-37247
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 98 participants
Where: 24 sitesin 2 countries
Study dates: Jan 2011to Apr 2013
Phase: Phase 1/2
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Over the 4 days prior to the randomization visit, the patient has a mean score greater than or equal to 5 (of 10) for "Average Pain Over the Past 24 Hours" for the pain in the affected leg as assessed by the 11-Point Numerical Rating Scale (NRS-11) captured in the electronic diaries. The patient must have valid (non-missing) data for at least 3 out of the 4 days, and the mean score must be at least 5 without rounding.
The patient has a current diagnosis of lumbosacral radicular pain. Pain must radiate into the leg in a dermatomal/myotomal distribution consistent with the diagnosis of lumbosacral radicular pain in the suspected involved nerve root. Based on history and medical records (if available), the duration of the current episode of pain must be between 6 and 52 weeks duration.
Diagnosis must be confirmed by magnetic resonance imaging (MRI) (or existing computed tomography [CT] or MRI related to the symptoms present at screening) performed within 6 months prior to screening and demonstrating disk herniation at a location consistent with the clinical symptoms of radicular pain. Other incidental pathology is permitted as long as it is asymptomatic and believed not causal of the primary diagnosis of lumbosacral radicular pain at the specific spinal level as described below.
The patient must have at least 1 of the following: a positive straight leg raise (L5-S1), positive femoral stretch test (L3-L4), or other positive test result upon physical examination that is consistent with the presence of nerve root irritation at the nerve root suspected to be involved in the diagnosed lumbosacral radicular pain at screening.
Herniation must affect L3-L4, L4-L5, or L5-S1 and must be consistent with clinical presentation of the current episode of lumbosacral radicular pain as described above.
Patients with significant or progressive sensory impairment or motor impairment (such as foot drop) must be assessed on a case-by-case basis by the investigator, and must in each case receive written approval of the Sponsor prior to randomization.

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There must be confirmation that the patient does not have an active tuberculosis infection at screening. The patient should have either a negative QuantiFERON®-TB Gold blood test or negative tuberculin skin test (TST) result at screening; however if QuantiFERON®-TB Gold test or TST is positive, a chest radiogram may be used to determine whether a patient has an active infection.
The patient is willing to keep all analgesic medication and other therapy usage (such as physiotherapy, acupuncture, or transcutaneous electrical nerve stimulation [TENS]) stable or decreased during the study and use only the rescue pain medication as needed and as specified by the protocol.
The patient is in good health (with the exception of the condition under study) as determined by a medical and psychiatric history, medical examination, ECG, serum chemistry, hematology, urinalysis, and serology.
Women of childbearing potential (ie, not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study, and have a negative pregnancy test at screening.

Who cannot join

The patient:
has a documented history of an allergic reaction (hives, rash, etc.) or a clinically significant intolerance to study drug or ingredients.
has a body mass index (BMI) greater than 40 kg/m2.
the patient has an established history of a major psychiatric disorder, not controlled with medication or appears to have anxiety that would interfere with clinical pain scores or participation in the trial.
has clinically significant abnormalities in clinical chemistry, hematology or urinalysis, including serum glutamic-oxaloacetic transaminase/aspartate aminotransferase (AST) or serum glutamic-pyruvic transaminase/alanine aminotransferase (ALT) greater than or equal to 3 times the upper limit of the reference range or an estimated glomerular filtration rate (eGFR) less than or equal to 30 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD] study formula) at screening.
has received an intra-epidural steroid injection for the treatment of the current episode of sciatica during the last 3 months prior to screening.

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has significant pain unrelated to the disk herniation that would significantly compromise assessment of the radicular back and leg pain related to the disk herniation.
has radiologic evidence of disk herniation at more than 1 spinal level, and clinical evidence of lumbosacral radicular pain at more than 1 spinal nerve corresponding to the levels of the multiple disk herniations.
has received any investigational drug within 30 days prior to screening, or is scheduled to receive an investigational drug other than blinded study drug during the course of this study.
has had lumbar or sacral back surgery related to the specific disk that is the cause of the radicular pain upon presentation to the study, or currently plans to undergo spine surgical intervention while in the study.
has received epidural corticosteroid injections in the back within 3 months of screening.
is involved in an ongoing worker's compensation claim, disability claim, or litigation related to any pain problem.
has any active infection that is not self-limiting and not resolved prior to study drug administration.
has a history of malignancy or evidence of malignancy or lymphoproliferative or neoplastic disease with the exception of successfully treated basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia within 5 years of the screening visit.
has a history of systemic fungal infection.
has a history of opportunistic infection within 3 months prior to screening.
has a history of known or suspected chronic infection, tuberculosis, hepatitis B virus (HBV), hepatitis C virus (HCV), or Human Immunodeficiency Virus (HIV). The investigator will review all medical history (including medication history), and patients found to be HIV positive based on medical review are to be excluded from the study.
has a history of any demyelinating disease, including multiple sclerosis and optic neuritis.
has used anti-tumor necrosis factor (TNF) receptor medication (anakinra [KINERET®, Biovitrum]) or anti-TNF medication (etanercept [ENBREL®, Amgen Inc.], infliximab [REMICADE®, Centocor Ortho Biotech Inc.], or adalimumab [HUMIRA®, Abbott Laboratories], or any experimental TNF inhibitor) within the past year.
has a planned joint replacement surgery or a history of infected joint prosthesis or has received antibiotics for a suspected infection of a joint prosthesis if that prosthesis has not been removed or replaced.
has been given live vaccines within 14 days of study drug administration.
has severe spinal stenosis or spondylolisthesis (grade 2 or higher).
has coagulopathy.
is a pregnant or lactating woman (any women becoming pregnant during the study will be withdrawn from the study).
has a history of diabetic neuropathy or peripheral neuropathy in the lower extremities.
has a history of any condition (not otherwise specified) known to be amenable to TNF inhibitors (e.g., Crohn's disease).
has a known allergy or idiosyncratic (atopic) reaction to contrast agent, local anesthetic, study drug, any ingredient listed as being present in a study formulation, or any other pain management compound likely to be prescribed in the study, including their metabolites (if applicable) or any ingredient listed as being present in their formulations.
has any clinically significant uncontrolled medical condition (treated or untreated).

Trial locations and contacts

24 sites in 2 countries.

Country

City, postcode or hospital

24 sites in 2 countries

United States20 sites

Teva Investigational Site 17
Altoona, Pennsylvania
Teva Investigational Site 9
Bloomington, Illinois
Teva Investigational Site 16
Dayton, Ohio
Teva Investigational Site 21
Eugene, Oregon
Teva Investigational Site 1
Greenville, South Carolina
Teva Investigational Site 22
La Mesa, California
Teva Investigational Site 18
Laguna Hills, California
Teva Investigational Site 10
Marietta, Georgia
Teva Investigational Site 13
Marietta, Georgia
Teva Investigational Site 11
North Charleston, South Carolina
Teva Investigational Site 4
Orem, Utah
Teva Investigational Site 14
Orlando, Florida
Teva Investigational Site 15
Overland Park, Kansas
Teva Investigational Site 19
Pasadena, California
Teva Investigational Site 2
Pasadena, California
Teva Investigational Site 3
Salt Lake City, Utah
Teva Investigational Site 5
Sarasota, Florida
Teva Investigational Site 8
Shreveport, Louisiana
Teva Investigational Site 6
Spartanburg, South Carolina
Teva Investigational Site 20
Winston-Salem, North Carolina

Other trials in United States

Australia4 sites

Teva Investigational Site 103
Caulfied South
Teva Investigational Site 102
Malvern East
Teva Investigational Site 100
North Terrace
Teva Investigational Site 101
St Leonards

Other trials in Australia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Study to Evaluate the Safety and Efficacy of CEP-37247 Administered at Single Doses of 0.5, 1, 3, 6, or 12 mg by the Transforaminal Epidural Route for the Treatment of Patients With Lumbosacral Radicular Pain Associated With Disk Herniation

Conditions: Sciatica
Being tested: CEP-37247, Placebo
Keywords: Sciatica, Pain
Medical subject headings: Sciatica, Pain

What participants receive

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

CEP-37247Drug
Also called placulumab
0.5-, 1-, 3-, 6-, and 12-mg doses of CEP-37247 will be administered by the transforaminal epidural route.
PlaceboDrug
Matching placebo vials will be filled with the buffered solution for CEP-37247.

Study groups in NCT01240876
Study group	Role	What they receive
CEP-37247	Experimental	Not described Receives: Drug: CEP-37247
Matching placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Occurrence of adverse events compared to placebo
Measured: throughout the 28-week double-blind treatment period
Mean change in the weekly average of daily average pain intensity (API) in the affected leg on the 11-Point Numerical Rating Scale (NRS-11)
The average pain intensity over the past 24 hours on the NRS-11 will be collected daily by electronic diary.
Measured: at week 4 compared with baseline

Secondary outcomes (19)

Weekly average of daily leg API score as assessed by the NRS-11 from electronic diary entries
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Measured: at each of the first 6 weeks
Weekly average of daily back API score as assessed by the NRS-11 from electronic diary entries
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Measured: at each of the first 6 weeks
Weekly average of daily worst leg pain score as assessed by the NRS-11 from electronic diary entries
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Measured: at each of the first 6 weeks
Weekly average of daily worst back pain score as assessed by the NRS-11 from electronic diary entries
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Measured: at each of the first 6 weeks
Patients with 30% and 50% reductions in average pain over the previous 24 hours as measured by the Brief Pain Inventory Short Form (BPI-SF)
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Measured: at 1, 2, 4, 6, 14, and 28 weeks
Change in total Oswestry Disability Index (ODI) score as well as subscale scores
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Measured: at 1, 2, 4, 6, 14, and 28 weeks
Score on the Patient Global Impression of Change
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Measured: at 1, 2, 4, 6, 14, and 28 weeks
Change in 36-Item Short Form Health Survey (SF-36) score
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Measured: from baseline to weeks 4, 14, and 28
Average daily amount of rescue medication used
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Measured: during each of the first 6 weeks of the 28-week double-blind treatment period
Patients requiring a subsequent injection of epidural steroids
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Measured: up to 28 weeks after CEP-37247 treatment
Patients requiring back surgery
Evaluate the efficacy of each dose of CEP-37247 as compared with placebo within each individual dose group and with the combined placebo group.
Measured: up to 28 weeks after CEP-37247 treatment
Evaluate the safety of CEP-37247 treatment as assessed by vital signs measurements
Measured: at weeks 1, 2, 4, 6, 14, and 28 (or early termination)
Evaluate the safety of CEP-37247 treatment as assessed by electrocardiogram (ECG) results
Measured: at week 4
Evaluate the safety of CEP-37247 treatment as assessed by clinical laboratory tests
Measured: at weeks 1, 2, 4, 6, 14, and 28 (or early termination)
Evaluate the safety of CEP-37247 treatment as assessed by physical examination
Measured: at weeks 4 and 28 (or early termination)
Evaluate the safety of CEP-37247 treatment as assessed by neurologic examination
Measured: at weeks 1, 2, 4 and 28 (or early termination)
Evaluate the safety of CEP-37247 treatment as assessed by concomitant medication usage
Measured: throughout the 28-week double-blind treatment period
Evaluate the safety of CEP-37247 treatment as assessed by immunogenicity tests
Measured: at weeks 2, 4, 6, 14, and 28 (or early termination)
Characterize the serum pharmacokinetics of CEP-37247 following epidural administration
Measured: Throughout the 28-week double-blind treatment period

Timeline

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

Jan 2011Apr 2013

First posted15 Nov 2010 (estimated)
Study startJan 2011
Primary completionMar 2013
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SciaticaStudies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01240876
Sponsor's protocol ID: C37247/1083
Status last verified: Jul 2016
First submitted: 10 Nov 2010
Last updated: 21 Jul 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sciatica trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Study to Evaluate the Safety and Efficacy of CEP-37247 Administered at Single Doses of 0.5, 1, 3, 6, or 12 mg by the Transforaminal Epidural Route for the Treatment of Patients With Lumbosacral Radicular Pain Associated With Disk Herniation
ClinicalTrials.gov ID: NCT01240876
Acronym / sponsor ID: C37247/1083
Conditions: Sciatica
Keywords: Sciatica, Pain
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: CephalonIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Mar 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 15 Nov 2010 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CEP-37247	Experimental	Drug: CEP-37247
Matching placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Over the 4 days prior to the randomization visit, the patient has a mean score greater than or equal to 5 (of 10) for "Average Pain Over the Past 24 Hours" for the pain in the affected leg as assessed by the 11-Point Numerical Rating Scale (NRS-11) captured in the electronic diaries. The patient must have valid (non-missing) data for at least 3 out of the 4 days, and the mean score must be at least 5 without rounding.
The patient has a current diagnosis of lumbosacral radicular pain. Pain must radiate into the leg in a dermatomal/myotomal distribution consistent with the diagnosis of lumbosacral radicular pain in the suspected involved nerve root. Based on history and medical records (if available), the duration of the current episode of pain must be between 6 and 52 weeks duration.
Diagnosis must be confirmed by magnetic resonance imaging (MRI) (or existing computed tomography [CT] or MRI related to the symptoms present at screening) performed within 6 months prior to screening and demonstrating disk herniation at a location consistent with the clinical symptoms of radicular pain. Other incidental pathology is permitted as long as it is asymptomatic and believed not causal of the primary diagnosis of lumbosacral radicular pain at the specific spinal level as described below.
The patient must have at least 1 of the following: a positive straight leg raise (L5-S1), positive femoral stretch test (L3-L4), or other positive test result upon physical examination that is consistent with the presence of nerve root irritation at the nerve root suspected to be involved in the diagnosed lumbosacral radicular pain at screening.
Herniation must affect L3-L4, L4-L5, or L5-S1 and must be consistent with clinical presentation of the current episode of lumbosacral radicular pain as described above.

Key exclusion criteria (28 listed)

has a documented history of an allergic reaction (hives, rash, etc.) or a clinically significant intolerance to study drug or ingredients.
has a body mass index (BMI) greater than 40 kg/m2.
the patient has an established history of a major psychiatric disorder, not controlled with medication or appears to have anxiety that would interfere with clinical pain scores or participation in the trial.
has clinically significant abnormalities in clinical chemistry, hematology or urinalysis, including serum glutamic-oxaloacetic transaminase/aspartate aminotransferase (AST) or serum glutamic-pyruvic transaminase/alanine aminotransferase (ALT) greater than or equal to 3 times the upper limit of the reference range or an estimated glomerular filtration rate (eGFR) less than or equal to 30 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD] study formula) at screening.
has received an intra-epidural steroid injection for the treatment of the current episode of sciatica during the last 3 months prior to screening.

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
CEP-37247Also: placulumab0.5-, 1-, 3-, 6-, and 12-mg doses of CEP-37247 will be administered by the transforaminal epidural route.	Drug	CEP-37247
PlaceboMatching placebo vials will be filled with the buffered solution for CEP-37247.	Drug	Matching placebo

Primary outcome

Occurrence of adverse events compared to placebo
Time frame: throughout the 28-week double-blind treatment period
Mean change in the weekly average of daily average pain intensity (API) in the affected leg on the 11-Point Numerical Rating Scale (NRS-11)
Time frame: at week 4 compared with baseline
The average pain intensity over the past 24 hours on the NRS-11 will be collected daily by electronic diary.

19 secondary outcomes

Weekly average of daily leg API score as assessed by the NRS-11 from electronic diary entries
Time frame: at each of the first 6 weeks
Weekly average of daily back API score as assessed by the NRS-11 from electronic diary entries
Time frame: at each of the first 6 weeks
Weekly average of daily worst leg pain score as assessed by the NRS-11 from electronic diary entries
Time frame: at each of the first 6 weeks
Weekly average of daily worst back pain score as assessed by the NRS-11 from electronic diary entries
Time frame: at each of the first 6 weeks
Patients with 30% and 50% reductions in average pain over the previous 24 hours as measured by the Brief Pain Inventory Short Form (BPI-SF)
Time frame: at 1, 2, 4, 6, 14, and 28 weeks
Change in total Oswestry Disability Index (ODI) score as well as subscale scores
Time frame: at 1, 2, 4, 6, 14, and 28 weeks
Score on the Patient Global Impression of Change
Time frame: at 1, 2, 4, 6, 14, and 28 weeks
Change in 36-Item Short Form Health Survey (SF-36) score
Time frame: from baseline to weeks 4, 14, and 28
Average daily amount of rescue medication used
Time frame: during each of the first 6 weeks of the 28-week double-blind treatment period
Patients requiring a subsequent injection of epidural steroids
Time frame: up to 28 weeks after CEP-37247 treatment
Patients requiring back surgery
Time frame: up to 28 weeks after CEP-37247 treatment
Evaluate the safety of CEP-37247 treatment as assessed by vital signs measurements
Time frame: at weeks 1, 2, 4, 6, 14, and 28 (or early termination)
Evaluate the safety of CEP-37247 treatment as assessed by electrocardiogram (ECG) results
Time frame: at week 4
Evaluate the safety of CEP-37247 treatment as assessed by clinical laboratory tests
Time frame: at weeks 1, 2, 4, 6, 14, and 28 (or early termination)
Evaluate the safety of CEP-37247 treatment as assessed by physical examination
Time frame: at weeks 4 and 28 (or early termination)
Evaluate the safety of CEP-37247 treatment as assessed by neurologic examination
Time frame: at weeks 1, 2, 4 and 28 (or early termination)
Evaluate the safety of CEP-37247 treatment as assessed by concomitant medication usage
Time frame: throughout the 28-week double-blind treatment period
Evaluate the safety of CEP-37247 treatment as assessed by immunogenicity tests
Time frame: at weeks 2, 4, 6, 14, and 28 (or early termination)
Characterize the serum pharmacokinetics of CEP-37247 following epidural administration
Time frame: Throughout the 28-week double-blind treatment period

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 21 Jul 2016.

Related trials for Sciatica

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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.

Sponsor's Medical Expert, Associate Director, Clinical Research, MD, PhD study director

Cephalon

24 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CEP-37247 in people with Sciatica, run by Cephalon at 24 sites in 2 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 10 inclusion and 28 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 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Australia. 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 combined 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.

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?

Occurrence of adverse events compared to placebo (time frame: throughout the 28-week double-blind treatment period). The study lists 2 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 NCT01240876.

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 21 Jul 2016.