Phase II Dose Titration Study in Patients With Neuropathic Pain

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00736151

Enrollment

272

Registered

2008-08-15

Start date

2004-05-31

Completion date

Unknown

Last updated

2009-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain

Brief summary

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

Interventions

DRUGRalfinamide

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change of pain intensity	Baseline to week 8 or last visit

Secondary

Measure	Time frame
The incidence of adverse events	From baseline to week 8 or last visit

Countries

Austria, Czechia, India, Italy, Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026