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

January 28, 2016 updated by: Sanofi

Multinational, Multicenter, Randomized Double-Blind, Placebo-Controlled, Parallel-Group Study of Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Olomouc, Czech Republic, 77200
        • Investigational Site Number 203002
      • Praha 10, Czech Republic, 10400
        • Investigational Site Number 203005
      • Praha 10, Czech Republic, 10400
        • Investigational Site Number 203006
  • Hungary
      • Budapest, Hungary, 1083
        • Investigational Site Number 348001
      • Budapest, Hungary, 1083
        • Investigational Site Number 348005
      • Budapest, Hungary, 1134
        • Investigational Site Number 348007
      • Budapest, Hungary, 1145
        • Investigational Site Number 348002
      • Debrecen, Hungary, 4043
        • Investigational Site Number 348006
      • Zalaegerszeg, Hungary, 8900
        • Investigational Site Number 348003
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Investigational Site Number 616001
      • Lublin, Poland, 10-022
        • Investigational Site Number 616002
      • Sandomierz, Poland, 27-600
        • Investigational Site Number 616007
      • Wloclawek, Poland, 87-800
        • Investigational Site Number 616004
  • Russian Federation
      • Kazan, Russian Federation, 420021
        • Investigational Site Number 643006
      • Kazan, Russian Federation, 420077
        • Investigational Site Number 643007
      • Moscow, Russian Federation, 117036
        • Investigational Site Number 643008
      • Moscow, Russian Federation, 123423
        • Investigational Site Number 643010
      • Moscow, Russian Federation, 127486
        • Investigational Site Number 643009
      • Moscow, Russian Federation, 129128
        • Investigational Site Number 643001
      • Moscow, Russian Federation
        • Investigational Site Number 643011
      • Nizhny Novgorod, Russian Federation, 603126
        • Investigational Site Number 643004
      • Novosibirsk, Russian Federation, 630054
        • Investigational Site Number 643012
      • St-Petersburg, Russian Federation, 190068
        • Investigational Site Number 643013
      • St-Petersburg, Russian Federation, 194044
        • Investigational Site Number 643003
      • St-Petersburg, Russian Federation, 195112
        • Investigational Site Number 643014
      • Yaroslavl, Russian Federation, 150030
        • Investigational Site Number 643005
  • Slovakia
      • Banska Bystrica, Slovakia, 97404
        • Investigational Site Number 703004
      • Dubnica Nad Vahom, Slovakia, 01841
        • Investigational Site Number 703001
      • Krompachy, Slovakia, 05342
        • Investigational Site Number 703003
  • Ukraine
      • Kiev, Ukraine, 02091
        • Investigational Site Number 804002
      • Kiev, Ukraine, 2091
        • Investigational Site Number 804005
      • Kyiv, Ukraine, 04114
        • Investigational Site Number 804004
      • Kyiv, Ukraine
        • Investigational Site Number 804003
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85741-3565
        • Investigational Site Number 840014
    • California
      • Garden Grove, California, United States, 92845
        • Investigational Site Number 840007
      • Newport Beach, California, United States, 92660
        • Investigational Site Number 840020
      • Santa Ana, California, United States, 92705
        • Investigational Site Number 840038
      • Tustin, California, United States, 92780
        • Investigational Site Number 840002
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Investigational Site Number 840046
      • Ocala, Florida, United States, 34471
        • Investigational Site Number 840013
      • Palm Beach Gardens, Florida, United States, 33418
        • Investigational Site Number 840034
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Investigational Site Number 840019
      • Indianapolis, Indiana, United States, 46254
        • Investigational Site Number 840012
    • Massachusetts
      • Framingham, Massachusetts, United States, 01702
        • Investigational Site Number 840042
      • Springfield, Massachusetts, United States, 01104
        • Investigational Site Number 840004
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Investigational Site Number 840035
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Investigational Site Number 840010
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Investigational Site Number 840037
    • New York
      • Hartsdale, New York, United States, 10530
        • Investigational Site Number 840040
      • New York, New York, United States, 10032
        • Investigational Site Number 840001
      • Rochester, New York, United States, 14618
        • Investigational Site Number 840033
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Investigational Site Number 840015
      • Winston Salem, North Carolina, United States, 27103
        • Investigational Site Number 840022
    • Ohio
      • Toledo, Ohio, United States, 43623
        • Investigational Site Number 840017
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Investigational Site Number 840044
      • Johnstown, Pennsylvania, United States, 19505
        • Investigational Site Number 840018
    • Tennessee
      • Tullahoma, Tennessee, United States, 37388
        • Investigational Site Number 840045
    • Texas
      • Austin, Texas, United States, 78731
        • Investigational Site Number 840006
      • Dallas, Texas, United States, 75230
        • Investigational Site Number 840043
      • Dallas, Texas, United States, 75231
        • Investigational Site Number 840032
    • Washington
      • Seattle, Washington, United States, 98122
        • Investigational Site Number 840016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SAR292833 dose level 1
Dose level 1 twice daily immediately after breakfast/dinner
Drug: SAR292833

Pharmaceutical form: capsule

Route of administration: oral
EXPERIMENTAL: SAR292833 dose level 2
Dose level 2 twice daily immediately after breakfast/dinner
Drug: SAR292833

Pharmaceutical form: capsule

Route of administration: oral
PLACEBO_COMPARATOR: Placebo
Placebo (for SAR292833) twice daily immediately after breakfast/dinner
Drug: placebo

Pharmaceutical form:capsule

Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the average daily pain intensity as measured by the 11-point NRS;
Time Frame: Baseline to 4 weeks
The average daily pain intensity is the mean of the last consecutive 7 days.
Baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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;
Time Frame: Baseline to 4 weeks
Baseline to 4 weeks
Change in Neuropathic Pain Symptom Inventory (NPSI) after 4 weeks treatment compared to baseline
Time Frame: Baseline to 4 weeks
Baseline to 4 weeks
Change in intensity of the mechanical allodynia after 4 weeks treatment compared to baseline using visual analog scale (VAS)
Time Frame: Baseline to 4 weeks
Baseline to 4 weeks
Amount of and time to first rescue medication intake during the treatment period.
Time Frame: 4 weeks
4 weeks
Change in Daily Sleep Interference Score (DSIS), clinical global impression of change (PGIC and CGIC).
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

October 28, 2011

First Submitted That Met QC Criteria

October 31, 2011

First Posted (ESTIMATE)

November 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 26, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT11917
  • 2011-001876-21 (EUDRACT_NUMBER)
  • U1111-1120-0404 (OTHER: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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