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

NCT01463397 | Completed Phase 2

• 3 other identifiers: ACT119172011-001876-21U1111-1120-0404
• Study Type: interventional
• Target: 191
• Locations: 7 countries
• Sites: 61

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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the average daily pain intensity as measured by the 11-point NRS;

  The average daily pain intensity is the mean of the last consecutive 7 days.

  Baseline to 4 weeks

Secondary Outcomes (5)

• Percentage of patients with reduction in pain intensity of at least 30% and 50% at endpoint compared to baseline derived from the primary efficacy endpoint;

  Baseline to 4 weeks

• Change in Neuropathic Pain Symptom Inventory (NPSI) after 4 weeks treatment compared to baseline

  Baseline to 4 weeks

• Change in intensity of the mechanical allodynia after 4 weeks treatment compared to baseline using visual analog scale (VAS)

  Baseline to 4 weeks

• Amount of and time to first rescue medication intake during the treatment period.

  4 weeks

• Change in Daily Sleep Interference Score (DSIS), clinical global impression of change (PGIC and CGIC).

  4 weeks

Study Arms (3)

SAR292833 dose level 1

EXPERIMENTAL

Dose level 1 twice daily immediately after breakfast/dinner

Drug: SAR292833

SAR292833 dose level 2

EXPERIMENTAL

Dose level 2 twice daily immediately after breakfast/dinner

Drug: SAR292833

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

SAR292833 DRUG

Pharmaceutical form: capsule Route of administration: oral

SAR292833 dose level 1; SAR292833 dose level 2

placebo DRUG

Pharmaceutical form:capsule Route of administration: oral

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sanofi: lead

Study Sites (61)

Investigational Site Number 840014

Tucson, Arizona, 85741-3565, United States

Location

Investigational Site Number 840007

Garden Grove, California, 92845, United States

Location

Investigational Site Number 840020

Newport Beach, California, 92660, United States

Location

Investigational Site Number 840038

Santa Ana, California, 92705, United States

Location

Investigational Site Number 840002

Tustin, California, 92780, United States

Location

Investigational Site Number 840046

Coral Gables, Florida, 33134, United States

Location

Investigational Site Number 840013

Ocala, Florida, 34471, United States

Location

Investigational Site Number 840034

Palm Beach Gardens, Florida, 33418, United States

Location

Investigational Site Number 840019

Evansville, Indiana, 47714, United States

Location

Investigational Site Number 840012

Indianapolis, Indiana, 46254, United States

Location

Investigational Site Number 840042

Framingham, Massachusetts, 01702, United States

Location

Investigational Site Number 840004

Springfield, Massachusetts, 01104, United States

Location

Investigational Site Number 840035

St Louis, Missouri, 63141, United States

Location

Investigational Site Number 840010

Las Vegas, Nevada, 89148, United States

Location

Investigational Site Number 840037

Albuquerque, New Mexico, 87109, United States

Location

Investigational Site Number 840040

Hartsdale, New York, 10530, United States

Location

Investigational Site Number 840001

New York, New York, 10032, United States

Location

Investigational Site Number 840033

Rochester, New York, 14618, United States

Location

Investigational Site Number 840015

Raleigh, North Carolina, 27612, United States

Location

Investigational Site Number 840022

Winston-Salem, North Carolina, 27103, United States

Location

Investigational Site Number 840017

Toledo, Ohio, 43623, United States

Location

Investigational Site Number 840044

Altoona, Pennsylvania, 16602, United States

Location

Investigational Site Number 840018

Johnstown, Pennsylvania, 19505, United States

Location

Investigational Site Number 840045

Tullahoma, Tennessee, 37388, United States

Location

Investigational Site Number 840006

Austin, Texas, 78731, United States

Location

Investigational Site Number 840043

Dallas, Texas, 75230, United States

Location

Investigational Site Number 840032

Dallas, Texas, 75231, United States

Location

Investigational Site Number 840016

Seattle, Washington, 98122, United States

Location

Investigational Site Number 203002

Olomouc, 77200, Czechia

Location

Investigational Site Number 203005

Prague, 10400, Czechia

Location

Investigational Site Number 203006

Prague, 10400, Czechia

Location

Investigational Site Number 348001

Budapest, 1083, Hungary

Location

Investigational Site Number 348005

Budapest, 1083, Hungary

Location

Investigational Site Number 348007

Budapest, 1134, Hungary

Location

Investigational Site Number 348002

Budapest, 1145, Hungary

Location

Investigational Site Number 348006

Debrecen, 4043, Hungary

Location

Investigational Site Number 348003

Zalaegerszeg, 8900, Hungary

Location

Investigational Site Number 616001

Bydgoszcz, 85-796, Poland

Location

Investigational Site Number 616002

Lublin, 10-022, Poland

Location

Investigational Site Number 616007

Sandomierz, 27-600, Poland

Location

Investigational Site Number 616004

Włocławek, 87-800, Poland

Location

Investigational Site Number 643006

Kazan', 420021, Russia

Location

Investigational Site Number 643007

Kazan', 420077, Russia

Location

Investigational Site Number 643008

Moscow, 117036, Russia

Location

Investigational Site Number 643010

Moscow, 123423, Russia

Location

Investigational Site Number 643009

Moscow, 127486, Russia

Location

Investigational Site Number 643001

Moscow, 129128, Russia

Location

Investigational Site Number 643011

Moscow, Russia

Location

Investigational Site Number 643004

Nizhny Novgorod, 603126, Russia

Location

Investigational Site Number 643012

Novosibirsk, 630054, Russia

Location

Investigational Site Number 643013

Saint Petersburg, 190068, Russia

Location

Investigational Site Number 643003

Saint Petersburg, 194044, Russia

Location

Investigational Site Number 643014

Saint Petersburg, 195112, Russia

Location

Investigational Site Number 643005

Yaroslavl, 150030, Russia

Location

Investigational Site Number 703004

Banská Bystrica, 97404, Slovakia

Location

Investigational Site Number 703001

Dubnica nad Váhom, 01841, Slovakia

Location

Investigational Site Number 703003

Krompachy, 05342, Slovakia

Location

Investigational Site Number 804002

Kiev, 02091, Ukraine

Location

Investigational Site Number 804005

Kiev, 2091, Ukraine

Location

Investigational Site Number 804004

Kyiv, 04114, Ukraine

Location

Investigational Site Number 804003

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 1, 2011
• Study Start: March 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 26, 2016

Record last verified: 2016-01

Locations

PL (4); CZ (3); SL (3); HU (6); US (28); UA (4); RU (13)