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Completed

NCT Number: NCT00736151

Phase II Dose Titration Study in Patients With Neuropathic Pain

The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitatsklinik Fur Neurologie, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ralfinamide

Drug

Oral tablets administered at rising doses of 80 - 320 mg/day

Primary outcomes

  1. Change of pain intensity

    Time frame: Baseline to week 8 or last visit

Secondary outcomes

  1. The incidence of adverse events

    Time frame: From baseline to week 8 or last visit

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Sponsors and collaborators

Lead sponsor

Newron Pharmaceuticals SPA

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Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
First posted
Aug 15, 2008
Registry last updated
Aug 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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