Phase II Dose Titration Study in Patients With Neuropathic Pain
- Registration Number
- NCT00736151
- Lead Sponsor
- Newron Pharmaceuticals SPA
- Brief Summary
The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 272
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Ralfinamide Ralfinamide administered orally at rising doses of 80 - 320 mg/day 2 Ralfinamide Placebo controlled with randomization of 2:1
- Primary Outcome Measures
Name Time Method Change of pain intensity Baseline to week 8 or last visit
- Secondary Outcome Measures
Name Time Method The incidence of adverse events From baseline to week 8 or last visit
Trial Locations
- Locations (46)
Universitatsklinik Fur Neurologie
🇦🇹Innsbruck, Austria
LKH
🇦🇹Klagenfurt, Austria
General Hospital AKH
🇦🇹Wien, Austria
Fakultni nemocnice Brno
🇨🇿Brno-Bhunice, Czech Republic
Fakultni nemocnice u svate' Anny v Brne
🇨🇿Brno, Czech Republic
University Hospital Olomouc
🇨🇿Olomouc, Czech Republic
Univercity Hospital Pilsen
🇨🇿Pizen, Czech Republic
Na Homolce Hospital
🇨🇿Prague, Czech Republic
Fakultni Thomayerova nemocnices poliklinikou
🇨🇿Praha, Czech Republic
Neurology Centre
🇮🇳Ahmedabad, India
Scroll for more (36 remaining)Universitatsklinik Fur Neurologie🇦🇹Innsbruck, Austria