Efficacy and Safety of Ralfinamide in Patients With Chronic Neuropathic Low Back Pain

NCT01019824 | Completed Phase 3 DMC

• 2 other identifiers: NW-1029/01-08EudraCT Nr.: 2008-006176-30
• Study Type: interventional
• Target: 411
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine if an experimental drug, ralfinamide, relieves your neuropathic low back pain, and if it demonstrates superiority to placebo, a "dummy" or sugar pill that contains no active medication. Ralfinamide, given as either 160 mg/day or 320 mg/day, taken in a divided dose twice-a-day, will be compared with placebo. If you are randomly (by chance) selected to receive placebo, you will receive this medication throughout the treatment period of the study. Data from this study will provide essential information for choosing the doses of ralfinamide to be used in the treatment of this type of pain and potentially other types of pain.

Conditions

Pain

Keywords

nerve compression; compression radiculopathy; post-traumatic/post-surgical lumbar radiculopathy

Outcome Measures

Primary Outcomes (1)

• The primary efficacy variable will be the change from baseline in the mean weekly pain score (11-point Likert scale).

  The primary efficacy endpoint will analyze the change from baseline to Week 12 of the mean weekly pain score

Study Arms (3)

Low Dose

EXPERIMENTAL

160 mg dose

Drug: Ralfinamide

High Dose

EXPERIMENTAL

320 mg dose

Drug: Ralfinamide

Placebo

PLACEBO COMPARATOR

Placebo Comparator

Drug: Ralfinamide

Interventions

Ralfinamide DRUG

Ralfinamide Oral Tablets, 160 or 320 mg per day

High Dose; Low Dose; 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:

• Patient presents in the physical/neurological examination with low back pain with or without radiation into the lower limb that must display a topography compatible with the L1 to S1 territory and/or respective sensory or motoric impairments.
• Patient must have chronic neuropathic low back pain with a minimum intensity of "40 mm" (moderate) or greater on the Visual Analogue Scale (VAS; 100-mm) at screening, and an average of "40 mm" or more at baseline (based on prior 7 days).
• The onset of pain has occurred at least three months, but not longer than 3 years, prior to the screening visit, as assessed by the investigator in the patient's medical history.
• Patient is affected by current neuropathic pain (pain provoked by a lesion of the peripheral nervous system). The diagnosis should be made by a neurologist/anaesthesiologist/pain specialist and based on history, clinical evaluation and/or laboratory findings (rule out systemic cause, e.g., hypothyroidism, rheumatoid arthritis, nephropathy, diabetes \[MNSI score \>2\]) in accordance with the taxonomy of the diagnostic criteria documented in the International Association for the Study of Pain (IASP) Classification of Chronic Pain. A neurological disease must be directly correlated with pain, including pain due to spinal root compression.
• If radiologic data supporting the diagnosis had been obtained previously it should be documented in the patient's records. In case radiologic examinations are not available, the Investigator should consider performing these examinations, if necessary to support the diagnosis, during the screening phase.
• Patient has one of the following causes of neuropathic low back pain: Non-cancer lumbar pain due to compression radiculopathy or post-traumatic/post-surgical lumbar radiculopathy.
• Patient's low back pain has a clear neuropathic component, as indicated by a rating on the Pain Detect Questionnaire (PD-Q) of greater than 18.
• Patient is 18-85 years of age, inclusive.
• Patient is willing and able to understand and sign an approved Informed Consent Form.

You may not qualify if:

• \. Females who are pregnant or lactating, or of childbearing potential, defined as follows: surgically sterilized for less than one year; aged ≥ 50 years and post-menopausal condition started less than 24 months prior to the screening visit; or aged \< 50 years and post-menopausal condition started less than 24 months prior, and/or post-menopausal status has not been confirmed by determination of the serum levels of FSH and 17-β estradiol; or fecund and not practicing double contraception method (e.g., hormonal contraceptive plus barrier method).
• \. Patients with any other cause of peripheral or central neuropathic pain (including psychogenic and nociceptive pain), pain due to metabolic (including diabetes; MNSI score \> 2) infectious or proliferative diseases, or pain due to any condition that is as severe as the neuropathic pain.
• \. Patients with a history of migrating pain and former mononeuropathy or neuralgias in other anatomical territories.
• \. Patients with severe trophic changes, severe swelling, joint deformities or stiff joint with limited passive movement, or patients who may be candidates for back surgery within 52 weeks after baseline.
• \. History or current diagnosis of positive test for Hepatitis B or C (unless vaccinated).
• \. Clinically significant, uncontrolled gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease (including non well-controlled hypertension), asthma, uncompensated chronic obstructive pulmonary disease (COPD), severe uncontrolled diabetes (HbA1c \> 10.0).
• \. Second- or third-degree atrioventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, significant ECG abnormalities or QTc ≥ 450 msec (males) or ≥ 470 msec (females), where QTc is based on Bazett's correction method.
• \. Concomitant disease likely to interfere with the study drug (e.g. capable of altering absorption, metabolism or elimination of drugs).

Sponsors & Collaborators

• Newron Pharmaceuticals SPA: lead
• Parexel: collaborator
• CliniRx: collaborator

Study Sites (1)

Parexel

London, England, United Kingdom

Location

MeSH Terms

Conditions

Pain; Neuroma

Interventions

Ralfinamide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Stefano Rossetti, MD

  Newron Pharmaceuticals SPA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 25, 2009
• Study Start: March 20, 2009
• Primary Completion: May 11, 2010
• Study Completion: August 9, 2011
• Last Updated: September 15, 2017

Record last verified: 2017-09

Locations

GB (1)