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Phase II Dose Titration Study in Patients With Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by:
Newron Pharmaceuticals S.p.A.
ClinicalTrials.gov Identifier:
NCT00736151
First received: August 13, 2008
Last updated: August 6, 2009
Last verified: August 2009
History of Changes
  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-Blind
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 Pharmaceuticals S.p.A.:

Primary Outcome Measures:
  • Change of pain intensity [ Time Frame: Baseline to week 8 or last visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence of adverse events [ Time Frame: From baseline to week 8 or last visit ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736151

  Show 47 Study Locations
Sponsors and Collaborators
Newron Pharmaceuticals S.p.A.
  More Information

No publications provided

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
Study First Received: August 13, 2008
Last Updated: August 6, 2009
Health Authority: Austria: Ethikkommission
Czech Republic: Ethics Committee
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 June 18, 2013