Phase II Dose Titration Study in Patients With Neuropathic Pain

Newron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Neuropathic Pain

Treatments: Drug: Ralfinamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00736151

EUDRACT Number 2004-000557-35

NW-1029/001/II/2003

Details and patient eligibility

About

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

Enrollment: 272 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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272 participants in 2 patient groups

1

Experimental group

Description:

Ralfinamide administered orally at rising doses of 80 - 320 mg/day

Treatment:

Drug: Ralfinamide

2

Active Comparator group

Description:

Placebo controlled with randomization of 2:1

Treatment:

Drug: Ralfinamide