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Neuropathic PainPhase 2AlchemillaNCT01463397

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

A Phase 2 study testing SAR292833 in people with Neuropathic Pain, run by Sanofi at 61 sites in 7 countries.

Completed

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

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Neuropathic Pain
What is being tested?
SAR292833
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
191 participants
Where
61 sitesin 7 countries
Study dates
Mar 2012to May 2013
Phase
Phase 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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -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.

Who cannot join

  • 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;
Show all 30Show fewer
  • 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.

Trial locations and contacts

61 sites in 7 countries.

61 sites in 7 countries

United States28 sites

  • Investigational Site Number 840037

    Albuquerque, New Mexico, 87109

  • Investigational Site Number 840044

    Altoona, Pennsylvania, 16602

  • Investigational Site Number 840006

    Austin, Texas, 78731

  • Investigational Site Number 840046

    Coral Gables, Florida, 33134

  • Investigational Site Number 840043

    Dallas, Texas, 75230

  • Investigational Site Number 840032

    Dallas, Texas, 75231

  • Investigational Site Number 840019

    Evansville, Indiana, 47714

  • Investigational Site Number 840042

    Framingham, Massachusetts, 01702

  • Investigational Site Number 840007

    Garden Grove, California, 92845

  • Investigational Site Number 840040

    Hartsdale, New York, 10530

  • Investigational Site Number 840012

    Indianapolis, Indiana, 46254

  • Investigational Site Number 840018

    Johnstown, Pennsylvania, 19505

  • Investigational Site Number 840010

    Las Vegas, Nevada, 89148

  • Investigational Site Number 840001

    New York, New York, 10032

  • Investigational Site Number 840020

    Newport Beach, California, 92660

  • Investigational Site Number 840013

    Ocala, Florida, 34471

  • Investigational Site Number 840034

    Palm Beach Gardens, Florida, 33418

  • Investigational Site Number 840015

    Raleigh, North Carolina, 27612

  • Investigational Site Number 840033

    Rochester, New York, 14618

  • Investigational Site Number 840038

    Santa Ana, California, 92705

  • Investigational Site Number 840016

    Seattle, Washington, 98122

  • Investigational Site Number 840004

    Springfield, Massachusetts, 01104

  • Investigational Site Number 840035

    St Louis, Missouri, 63141

  • Investigational Site Number 840017

    Toledo, Ohio, 43623

  • Investigational Site Number 840014

    Tucson, Arizona, 85741-3565

  • Investigational Site Number 840045

    Tullahoma, Tennessee, 37388

  • Investigational Site Number 840002

    Tustin, California, 92780

  • Investigational Site Number 840022

    Winston-Salem, North Carolina, 27103

Other trials in United States

Russia13 sites

  • Investigational Site Number 643006

    Kazan', 420021

  • Investigational Site Number 643007

    Kazan', 420077

  • Investigational Site Number 643008

    Moscow, 117036

  • Investigational Site Number 643010

    Moscow, 123423

  • Investigational Site Number 643009

    Moscow, 127486

  • Investigational Site Number 643001

    Moscow, 129128

  • Investigational Site Number 643011

    Moscow

  • Investigational Site Number 643004

    Nizhny Novgorod, 603126

  • Investigational Site Number 643012

    Novosibirsk, 630054

  • Investigational Site Number 643013

    Saint Petersburg, 190068

  • Investigational Site Number 643003

    Saint Petersburg, 194044

  • Investigational Site Number 643014

    Saint Petersburg, 195112

  • Investigational Site Number 643005

    Yaroslavl, 150030

Other trials in Russia

Hungary6 sites

  • Investigational Site Number 348001

    Budapest, 1083

  • Investigational Site Number 348005

    Budapest, 1083

  • Investigational Site Number 348007

    Budapest, 1134

  • Investigational Site Number 348002

    Budapest, 1145

  • Investigational Site Number 348006

    Debrecen, 4043

  • Investigational Site Number 348003

    Zalaegerszeg, 8900

Other trials in Hungary

Poland4 sites

  • Investigational Site Number 616001

    Bydgoszcz, 85-796

  • Investigational Site Number 616002

    Lublin, 10-022

  • Investigational Site Number 616007

    Sandomierz, 27-600

  • Investigational Site Number 616004

    Włocławek, 87-800

Other trials in Poland

Ukraine4 sites

  • Investigational Site Number 804002

    Kiev, 02091

  • Investigational Site Number 804005

    Kiev, 2091

  • Investigational Site Number 804004

    Kyiv, 04114

  • Investigational Site Number 804003

    Kyiv

Other trials in Ukraine

Czechia3 sites

  • Investigational Site Number 203002

    Olomouc, 77200

  • Investigational Site Number 203005

    Prague, 10400

  • Investigational Site Number 203006

    Prague, 10400

Other trials in Czechia

Slovakia3 sites

  • Investigational Site Number 703004

    Banská Bystrica, 97404

  • Investigational Site Number 703001

    Dubnica nad Váhom, 01841

  • Investigational Site Number 703003

    Krompachy, 05342

Other trials in Slovakia

About this study

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

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).

Read more

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.
Read the detailed description

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

Being tested
SAR292833, placebo
Medical subject headings
Neuralgia

What participants receive

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

  • SAR292833Drug

    Pharmaceutical form: capsule

    Route of administration: oral

  • placeboDrug

    Pharmaceutical form:capsule

    Route of administration: oral

Study groups in NCT01463397
Study groupRoleWhat they receive
SAR292833 dose level 1ExperimentalDose level 1 twice daily immediately after breakfast/dinner
Receives: Drug: SAR292833
SAR292833 dose level 2ExperimentalDose level 2 twice daily immediately after breakfast/dinner
Receives: Drug: SAR292833
PlaceboPlacebo comparatorPlacebo (for SAR292833) twice daily immediately after breakfast/dinner
Receives: Drug: placebo

What is being measured

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

  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.

    Measured: Baseline to 4 weeks

Secondary outcomes (5)

  1. 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;

    Measured: Baseline to 4 weeks

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

    Measured: Baseline to 4 weeks

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

    Measured: Baseline to 4 weeks

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

    Measured: 4 weeks

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

    Measured: 4 weeks

Timeline

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

  1. First posted1 Nov 2011 (estimated)
  2. Study startMar 2012
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01463397
Sponsor's protocol ID
ACT11917
Other IDs
2011-001876-21, U1111-1120-0404
Acronym
Alchemilla
Status last verified
Jan 2016
First submitted
28 Oct 2011
Last updated
26 Feb 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR292833 in people with Neuropathic Pain, run by Sanofi at 61 sites in 7 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 3 inclusion and 30 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 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Russia, Hungary, Poland, Ukraine and 2 more countries. 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 phase mean?

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?

Change from baseline in the average daily pain intensity as measured by the 11-point NRS; (time frame: Baseline to 4 weeks). 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 NCT01463397.

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 26 Feb 2016.

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