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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01463397
First received: October 28, 2011
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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.

Condition Intervention Phase
Neuropathic Pain
Drug: SAR292833
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline to the 4th week of treatment 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. [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in Neuropathic Pain Symptom Inventory (NPSI) after 4 weeks treatment compared to baseline [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Amount of and time to first rescue medication intake during the treatment period. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in sleep (DSIS), global impression of change (PGIC and CGIC). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR292833 dose level 1
Dose level 1 BID immediately after breakfast/dinner
Drug: SAR292833
Pharmaceutical form:capsule Route of administration: oral
Experimental: SAR292833 dose level 2
Dose level 2 BID immediately after breakfast/dinner
Drug: SAR292833
Pharmaceutical form:capsule Route of administration: oral
Placebo Comparator: Placebo
BID immediately after breakfast/dinner
Drug: placebo
placebo comparator

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463397

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01463397     History of Changes
Other Study ID Numbers: ACT11917, 2011-001876-21, U1111-1120-0404
Study First Received: October 28, 2011
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014