Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis

PHASE2TerminatedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

September 30, 2008

Study Completion Date

November 30, 2008

Conditions
Muscle Spasticity
Interventions
DRUG

tolperisone HCl

Low dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks

DRUG

tolperisone HCl

High dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks

DRUG

tolperisone HCl

Placebo three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks

Trial Locations (28)

11000

Clinical Center of Serbia Institute of Neurology, Belgrade

12555

Facharztin fur Neurologie und Psychiatrie, Berlin

13053

Facharzt fur Neurologie und Psychiatrie, Berlin

15006

University Hospital Motol, Prague

15526

Facharzt fur Neurologie, Bad Saarow

18000

Clinical Center Nis Clinic of Neurology, Niš

30460

University Hospital Plzen, Pilsen

40212

Neuro-Consil GmbH, Düsseldorf

44805

Neurological practice, Bochum

50005

University Hospital Hradec Kralove, Hradec Králové

50767

Neurological practice, Cologne

61018

Central Clinical Hospital Ukrzalinznytsi (Dept. Neur. No. 1), Kharkiv

Central Clinical Hospital Ukrzalinznytsi (Dept. Neur. No. 3), Kharkiv

61068

Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine, Kharkiv

65014

Odesa Regional Psychoneurological Dispensary, Odesa

65691

Annes University Hospital, Brno

76008

Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk

82166

X-pert-med GmbH, Gräfelfing

88018

Uzhgorod Regional Centre of Neurosurgery and Neurology, Uzhhorod

95017

M.O.Semashko Republican Clinical Hospital, Simferopol

194291

Institute of Human Brain, Saint Petersburg

197376

Leningrad Regional Clinical Hospital, Saint Petersburg

198510

Nikolaevskaya Hospital, Complex Rehabilitation Department, Saint Petersburg

603076

City Hospital #33, Nizhny Novgorod

603126

Regional Clinical Hospital named Semashko, Nizhny Novgorod

D-13156

Private practice, Berlin

D022417

Asklepios Klinik Nord-Heidberg, Hamburg

03115

Institute of Clinical Radiology of the Scientific Centre of Radiation Medicine of the AMS of Ukraine, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Avigen

INDUSTRY

NCT00532532 - Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis | Biotech Hunter | Biotech Hunter