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Phase II Dose Titration Study in Patients With Neuropathic Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00736151
First Posted: August 15, 2008
Last Update Posted: August 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Newron
  Purpose
The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain.

Condition Intervention Phase
Neuropathic Pain Drug: Ralfinamide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Basic Science
Official Title: A Phase II, Multicentre, Pilot, Randomised, Double Blind Placebo Controlled Dose Titration Study to Evaluate the Safety, Maximum Tolerated Dose and Preliminary Evidence of Efficacy of Orally Administered Ralfinamide at Four Doses (80, 160, 240 and 320 mg/Day) in Patients With Neuropathic Pain

Further study details as provided by Newron:

Primary Outcome Measures:
  • Change of pain intensity [ Time Frame: Baseline to week 8 or last visit ]

Secondary Outcome Measures:
  • The incidence of adverse events [ Time Frame: From baseline to week 8 or last visit ]

Enrollment: 272
Study Start Date: May 2004
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ralfinamide administered orally at rising doses of 80 - 320 mg/day
Drug: Ralfinamide
Oral tablets administered at rising doses of 80 - 320 mg/day
Active Comparator: 2
Placebo controlled with randomization of 2:1
Drug: Ralfinamide
Oral tablets administered at rising doses of 80 - 320 mg/day

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients
  • Females post-menopausal for at least 12 months, 24 months in India, Poland, and Austria
  • Diagnosed by neurologist with current neuropathic pain

Exclusion Criteria:

  • See inclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736151


  Show 47 Study Locations
Sponsors and Collaborators
Newron
  More Information

Responsible Party: Stefano Rossetti, MD, Newron Pharmaceuticals S.p.A
ClinicalTrials.gov Identifier: NCT00736151     History of Changes
Other Study ID Numbers: NW-1029/001/II/2003
EUDRACT Number 2004-000557-35
First Submitted: August 13, 2008
First Posted: August 15, 2008
Last Update Posted: August 7, 2009
Last Verified: August 2009

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