Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain

NCT ID: NCT01463397

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-05-31

Brief Summary

Primary Objective:

To assess the efficacy of SAR292833 versus placebo in reducing pain intensity associated with chronic peripheral neuropathic pain using 11-point numerical rating scale (NRS).

Secondary Objectives:

• To compare the effects of SAR292833 with placebo on the change of neuropathic pain symptoms versus baseline Neuropathic Pain Symptoms Inventory (NPSI);
• To evaluate the effects of SAR292833 in comparison to placebo on the change in pain intensity of mechanical allodynia;
• To investigate the safety and tolerability of SAR292833 in comparison to placebo;
• To investigate the pharmacokinetics (PK) and the relationships between main efficacy parameters or pharmacodynamic effect (PD) and pharmacokinetics (PK/PD) of SAR292833 in patients with chronic peripheral neuropathic pain.

Detailed Description

Total study duration (from screening to last follow-up visit) is 9 weeks that includes a 3 week follow-up period.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SAR292833 dose level 1

Dose level 1 twice daily immediately after breakfast/dinner

Group Type: EXPERIMENTAL

SAR292833

Intervention Type: DRUG

Pharmaceutical form: capsule

Route of administration: oral

SAR292833 dose level 2

Dose level 2 twice daily immediately after breakfast/dinner

Group Type: EXPERIMENTAL

SAR292833

Intervention Type: DRUG

Pharmaceutical form: capsule

Route of administration: oral

Placebo

Placebo (for SAR292833) twice daily immediately after breakfast/dinner

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Pharmaceutical form:capsule

Route of administration: oral

Interventions

SAR292833

Pharmaceutical form: capsule

Route of administration: oral

Intervention Type: DRUG

placebo

Pharmaceutical form:capsule

Route of administration: oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-The study will include adult patients of either gender, 18 - 85 of age, who have signed the informed consent form, and presenting with chronic peripheral neuropathic pain associated with: diabetic polyneuropathy, post-herpetic neuralgia.

• The neuropathic pain must have a distinct neuroanatomically plausible distribution with sensory signs and symptoms confirmed by DN4 (Douleur Neuropathique en 4 questions) score of ≥4 and being present for more than 3 months.
• SAR292833 should be taken in fed condition. Therefore, only patients who were judged to be reliable to fulfill this condition (used to having breakfast and dinner) will be included in the study.

Exclusion Criteria

• Patients with a baseline average daily pain intensity for their neuropathic pain < 5 on the 11-point NRS over the last 7 days before randomization;
• Patients with a pain intensity of ≥ 9 on the 11-point NRS at Visit 1;
• Any pain other than the neuropathic pain of equal or greater severity;
• Sensory polyneuropathy post chemotherapy or in the context of cancer or AIDS;
• Patients with complex regional pain syndrome;
• Trigeminal neuralgia;
• Patients with clinically significant or uncontrolled hepatic, metabolic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that might interfere with the evaluation of study medication according to Investigator's medical judgment;
• Patients on statins metabolized by CYP3A4, (e.g. simvastatin, atorvastatin) and abnormal CPK level;
• Major depression;
• Serum creatinine >150 μmol/L;
• ALT 3 x ULN;
• Total bilirubin > 1.5 x ULN except known Gilbert syndrome;
• Presence of signs of clinically significant abnormalities on a standard electrocardiogram (ECG) recording at the screening visit according to Investigator's medical judgment;
• Pregnant or breastfeeding women;
• Women of childbearing potential (WOCBP), not protected by highly effective contraceptive method of birth control;
• Patients with diabetes mellitus and time between diagnosis of diabetes and enrolment <6 months;
• Patients with diabetes mellitus and HbA1c >10% or fasting plasma glucose >250 mg/dL;
• Use of the following drugs within 7 days prior to start with the pain intensity assessment (Visit 2):
• Antidepressants (except for stable [>30 days] regimens of Selective serotonin reuptake inhibitors (SSRIs) for treatment of anxiety or depression), anticonvulsants or mexiletine for the treatment of pain;
• Opioids or morphinomimetics;
• Fatty acid supplements, primrose oil, myoinositol, chromium picolinate that are known to be used in neuropathic pain;
• Acetyl salicylic acid (ASA) except up to 325 mg/d for myocardial infarction or transient ischemic attack prophylaxis;
• Benzodiazepines other than indicated at low doses for sleep disorders;
• Capsaicin patch;
• Lidocaine patch;
• Electroconvulsive therapy within 30 days of baseline evaluation;
• CYP3A4 potent and moderate inhibitors;
• CYP3A4 potent and moderate inducers;
• Substrates of CYP3A4 with narrow therapeutic window.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840014

Tucson, Arizona, United States

Investigational Site Number 840007

Garden Grove, California, United States

Investigational Site Number 840020

Newport Beach, California, United States

Investigational Site Number 840038

Santa Ana, California, United States

Investigational Site Number 840002

Tustin, California, United States

Investigational Site Number 840046

Coral Gables, Florida, United States

Investigational Site Number 840013

Ocala, Florida, United States

Investigational Site Number 840034

Palm Beach Gardens, Florida, United States

Investigational Site Number 840019

Evansville, Indiana, United States

Investigational Site Number 840012

Indianapolis, Indiana, United States

Investigational Site Number 840042

Framingham, Massachusetts, United States

Investigational Site Number 840004

Springfield, Massachusetts, United States

Investigational Site Number 840035

St Louis, Missouri, United States

Investigational Site Number 840010

Las Vegas, Nevada, United States

Investigational Site Number 840037

Albuquerque, New Mexico, United States

Investigational Site Number 840040

Hartsdale, New York, United States

Investigational Site Number 840001

New York, New York, United States

Investigational Site Number 840033

Rochester, New York, United States

Investigational Site Number 840015

Raleigh, North Carolina, United States

Investigational Site Number 840022

Winston-Salem, North Carolina, United States

Investigational Site Number 840017

Toledo, Ohio, United States

Investigational Site Number 840044

Altoona, Pennsylvania, United States

Investigational Site Number 840018

Johnstown, Pennsylvania, United States

Investigational Site Number 840045

Tullahoma, Tennessee, United States

Investigational Site Number 840006

Austin, Texas, United States

Investigational Site Number 840043

Dallas, Texas, United States

Investigational Site Number 840032

Dallas, Texas, United States

Investigational Site Number 840016

Seattle, Washington, United States

Investigational Site Number 203002

Olomouc, , Czechia

Investigational Site Number 203005

Prague, , Czechia

Investigational Site Number 203006

Prague, , Czechia

Investigational Site Number 348001

Budapest, , Hungary

Investigational Site Number 348005

Budapest, , Hungary

Investigational Site Number 348007

Budapest, , Hungary

Investigational Site Number 348002

Budapest, , Hungary

Investigational Site Number 348006

Debrecen, , Hungary

Investigational Site Number 348003

Zalaegerszeg, , Hungary

Investigational Site Number 616001

Bydgoszcz, , Poland

Investigational Site Number 616002

Lublin, , Poland

Investigational Site Number 616007

Sandomierz, , Poland

Investigational Site Number 616004

Włocławek, , Poland

Investigational Site Number 643006

Kazan', , Russia

Investigational Site Number 643007

Kazan', , Russia

Investigational Site Number 643008

Moscow, , Russia

Investigational Site Number 643010

Moscow, , Russia

Investigational Site Number 643009

Moscow, , Russia

Investigational Site Number 643001

Moscow, , Russia

Investigational Site Number 643011

Moscow, , Russia

Investigational Site Number 643004

Nizhny Novgorod, , Russia

Investigational Site Number 643012

Novosibirsk, , Russia

Investigational Site Number 643013

Saint Petersburg, , Russia

Investigational Site Number 643003

Saint Petersburg, , Russia

Investigational Site Number 643014

Saint Petersburg, , Russia

Investigational Site Number 643005

Yaroslavl, , Russia

Investigational Site Number 703004

Banská Bystrica, , Slovakia

Investigational Site Number 703001

Dubnica nad Váhom, , Slovakia

Investigational Site Number 703003

Krompachy, , Slovakia

Investigational Site Number 804002

Kiev, , Ukraine

Investigational Site Number 804005

Kiev, , Ukraine

Investigational Site Number 804004

Kyiv, , Ukraine

Investigational Site Number 804003

Kyiv, , Ukraine

Countries

United States; Czechia; Hungary; Poland; Russia; Slovakia; Ukraine

Other Identifiers

2011-001876-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1120-0404

Identifier Type: OTHER

Identifier Source: secondary_id

ACT11917

Identifier Type: -

Identifier Source: org_study_id