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.

Completed

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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

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

Change of pain intensity

Time frame: Baseline to week 8 or last visit

Secondary outcomes

The incidence of adverse events

Time frame: From baseline to week 8 or last visit

Sponsors and collaborators

Lead sponsor

Newron Pharmaceuticals SPA

Industry

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.

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.

Completed