Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis

PHASE2CompletedINTERVENTIONAL
Enrollment

206

Participants

Timeline

Start Date

February 28, 2003

Primary Completion Date

December 31, 2003

Study Completion Date

December 31, 2003

Conditions
Multiple Sclerosis
Interventions
DRUG

Placebo

Placebo for 15 weeks

DRUG

10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)

"2 week up titration (10 mg)~12 weeks stable dose (10 mg)~1 week down titration (10 mg)"

DRUG

15 mg fampridine-SR (4-aminopyridine, 4-AP)

"10 mg twice daily for 1 week~15 mg twice daily for 14 weeks~2 week up titration (10 mg x 1 week, 15 mg x 1 week)~12 weeks stable dose (15 mg)~1 week down titration (10 mg)"

DRUG

20 mg fampridine-SR (4-aminopyridine, 4-AP)

"2 week up titration (10 mg x 1 week, 15 mg x 1 week)~12 weeks stable dose (20 mg)~1 week down titration (15 mg x 3 days, 10 mg x 4 days)"

Trial Locations (25)

10029

Mt. Sinai School of Medicine - MS Center, New York

11219

Maimonides MS Care Center, Brooklyn

11794

SUNY Stony Brook, Stony Brook

14642

University of Rochester Medical School, Rochester

19107

Thomas Jefferson University, Philadelphia

21210

University of Maryland at Baltimore, Baltimore

28207

Carolinas Medical Center MS Center, Charlotte

30309

Shepherd Center, Atlanta

43210

Ohio State University, Columbus

44195

Cleveland Clinic Foundation, Cleveland

53792

University of Wisconsin Hospital and Clinics, Madison

55454

Fairview MS Center, Minneapolis

60637

University of Chicago, Chicago

63110

Washington University School of Medicine, St Louis

77030

University of Texas-Houston, Houston

85013

Barrow Neurological Institute at St. Joseph Hospital and Medical Center, Phoenix

87131

University of New Mexico, Albuquerque

90033

USC MS Comprehensive Care Center, Los Angeles

97201

Oregon Health Sciences University; MS Center, Portland

98122

Swedish Medical MS Center, Seattle

98195

University of Washington School of Medicine, Seattle

06510

Yale University MS Center, New Haven

07666

Gimbel MS Center, Teaneck

T2N 2T9

Foothills Medical Centre, Calgary

M5B 1WB

St. Michael's Hospital, Toronto

Sponsors
All Listed Sponsors
lead

Acorda Therapeutics

INDUSTRY