- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01683838
Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury
Double-Blind, Placebo-Controlled, 12-Week Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Moderate to Severe Spasticity Resulting From Chronic, Incomplete Spinal Cord Injury
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3A 1M4
- Health Sciences Centre
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 3Z5
- Chedoke-McMaster Hospital
-
Kingston, Ontario, Canada, K7L 5A2
- St. Mary's of the Lake Hospital
-
-
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35233
- UAB School of Medicine, 190 Spain Rehab Center
-
-
California
-
Long Beach, California, Forenede Stater, 90822
- Long Beach VA Medical Center
-
Sacramento, California, Forenede Stater, 95817
- University of California, Davis
-
San Jose, California, Forenede Stater, 95128
- Santa Clara Valley Medical Center
-
-
Colorado
-
Englewood, Colorado, Forenede Stater, 80110
- Craig Hospital
-
-
Connecticut
-
New Britain, Connecticut, Forenede Stater, 06503
- Hospital for Special Care
-
-
Illinois
-
Hines, Illinois, Forenede Stater, 60141
- Hines VA Hospital
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02118
- Boston University Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan
-
Detroit, Michigan, Forenede Stater, 48201
- Rehabilitation Institute of Michigan
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55417
- Minneapolis VA Hospital
-
-
Missouri
-
Columbia, Missouri, Forenede Stater, 65212
- University of Missouri
-
Saint Louis, Missouri, Forenede Stater, 63104
- St. Louis University
-
-
New York
-
Rochester, New York, Forenede Stater, 14642
- University of Rochester/Strong Memorial Hospital
-
Syracuse, New York, Forenede Stater, 13045
- SUNY Upstate Clinical Trials Office
-
West Haverstraw, New York, Forenede Stater, 13045
- Helen Hayes Hospital
-
-
North Carolina
-
Charlotte, North Carolina, Forenede Stater, 28203
- Charlotte Institute of Rehabilitation
-
Wilmington, North Carolina, Forenede Stater, 28402
- Coastal AHEC
-
-
Ohio
-
Columbus, Ohio, Forenede Stater, 43210
- Ohio State University
-
Dayton, Ohio, Forenede Stater, 45409
- Miami Valley Hospital- Rehabilitation Institute of Medicine
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University Hospital
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75216
- VA North Texas Health Care System
-
Dallas, Texas, Forenede Stater, 75390
- Southwestern Medical Center at Dallas
-
-
Virginia
-
Falls Church, Virginia, Forenede Stater, 22042
- INOVA Institute of Research and Education
-
Richmond, Virginia, Forenede Stater, 23298
- Medical College of Virginia/VCU
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98195
- University of Washington Medical Center, Dept. of Rehabilitation
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53295
- Wood VA Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months)
- Moderate to severe lower-limb spasticity
- Able to give informed consent and willing to comply with protocol
Exclusion Criteria:
- Pregnancy
- History of seizures
- Existing or history of frequent Urinary Tract Infections
- History of drug or alcohol abuse
- Allergy to pyridine-containing substances
- Received a botox injection 4 months prior to study
- Received an investigational drug within 30 days
- Previously treated with 4-aminopyridine (4-AP)
- Not on stable medication dosing in 3 weeks prior to study
- Abnormal ECG or laboratory value at screening
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo
|
Placebo
|
Aktiv komparator: fampridin-SR 50mg/dag
|
25 mg bud (to gange dagligt)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
Tidsramme: Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
|
The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale: 1=no increased tone; 2=slight increase in tone, giving a "catch" when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension. The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity. |
Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
|
Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores
Tidsramme: Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
|
The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome. The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted. |
Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores
Tidsramme: Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
|
The Spasm Frequency score is the average rating by the clinician of the left and right arm(s) and leg(s), each evaluated on a 4-point scale (from 0=no spasms to 4=spontaneous spasms occurring more than ten times per hour), with higher scores denoting a greater degree of muscle spasms. The Spasm Severity score is the average rating of the left and right arm(s) and leg(s), each evaluated on a three-point scale (mild, moderate, or severe) as rated by the clinician on the basis of patient self-report. On both, a negative change in score signifies improvement in muscle spasms. The average Spasm Frequency/Spasm Severity Score was calculated as the average of the left and right non-missing scores. |
Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
|
Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores
Tidsramme: Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)
|
The supervising clinician rated the patient's neurological condition following treatment as compared to the screening visit on a seven-point scale (from 1=very much improved to 7=very much worse).
The assessment was based on the clinician's overall impression of the patient's neurological status (specifically bowel, bladder, and sexual function; spasticity; and other neurological functions) and general state of health related to his or her participation in the study.
Negative change scores indicated a change for the better.
|
Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)
|
Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score
Tidsramme: Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98
|
Ten key muscle groups for the right and left sides were rated on a 0 (absent) to 5 (normal) scale, with a possible total score of 100.
Higher positive change scores indicate improved motor function.
|
Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98
|
Change From Baseline in Mean International Index of Erectile Function (IIEF) Score
Tidsramme: Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98
|
Male patients were asked to complete the IIEF questionnaire on sexual function. The IIEF is a brief, reliable, and valid self-administered questionnaire of 15 questions (items) that were categorized into five domains: Erectile Function (EF) scores: 0-6 Severe dysfunction, 7-12 Moderate dysfunction, 13-18 Mild to moderate dysfunction, 19-24 Mild dysfunction, 25-30 No dysfunction. Orgasmic Function (OF) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Sexual Desire (SD) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Intercourse Satisfaction (IS) score range: 0-3 Severe dysfunction to 13-15 No dysfunction, and Overall Satisfaction (OS) score range: 0-2 Severe dysfunction to 9-10 No dysfunction. Domain scores were derived by summing the individual items within a given domain. Final scale ranges from 0 (negative) to 5 (positive). A positive change in IIEF domain scores signifies improvement. |
Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98
|
Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores
Tidsramme: Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98
|
The FSFI is a brief, reliable, and valid self-administered questionnaire of 19 questions (items). It contains six domains: Desire (2 items score range: 1 Very low or none at all to 5 Very high), Arousal (4 items score range: 0 No sexual activity to 5 Almost always or always), Lubrication (4 items score range: 0 No sexual activity to 5 Almost always or always), Orgasm (3 items score range: 0 No sexual activity to 5 Almost always or always), Satisfaction (3 items score range: 0 No sexual activity to 5 Very satisfied) and Pain (3 items score range: 0 Did not attempt intercourse to 5 Almost never or never). A positive change signifies improvement. |
Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98
|
Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores
Tidsramme: Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98
|
Bowel/bladder questions pertaining to the average number of times per day the patient experienced accidental urination/leakage and the average number of bowel movements per day were asked of all patients daily. A negative change in patient bladder/bowel function diary score signifies improvement. |
Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98
|
Adjusted Mean Change in Subject Bowel Function Diary Scores
Tidsramme: Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98
|
Bowel questions pertaining to the average number of minutes per day spent on bowel routine were asked of all patients daily. A negative change in patient bowel function diary score signifies improvement. |
Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Andrew Blight, MD, Acorda Therapeutics
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neurologiske manifestationer
- Muskuloskeletale sygdomme
- Muskelsygdomme
- Neuromuskulære manifestationer
- Traumer, nervesystemet
- Rygmarvssygdomme
- Muskelhypertoni
- Sår og skader
- Rygmarvsskader
- Muskelspasticitet
- Molekylære mekanismer for farmakologisk virkning
- Membrantransportmodulatorer
- Kaliumkanalblokkere
- 4-aminopyridin
Andre undersøgelses-id-numre
- SCI-F302
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Placebo
-
SamA Pharmaceutical Co., LtdUkendtAkut bronkitis | Akut øvre luftvejsinfektionKorea, Republikken
-
National Institute on Drug Abuse (NIDA)AfsluttetBrug af cannabisForenede Stater
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyAfsluttetMandlige forsøgspersoner med type II-diabetes (T2DM)Tyskland
-
Heptares Therapeutics LimitedAfsluttetFarmakokinetik | SikkerhedsproblemerDet Forenede Kongerige
-
Regado Biosciences, Inc.AfsluttetSund frivilligForenede Stater
-
Longeveron Inc.AfsluttetHypoplastisk venstre hjerte syndromForenede Stater
-
Texas A&M UniversityNutraboltAfsluttetGlucose and Insulin Response
-
ItalfarmacoAfsluttetBeckers muskeldystrofiHolland, Italien
-
Universidade Estadual de LondrinaConselho Nacional de Desenvolvimento Científico e Tecnológico; Coordination...AfsluttetSund og rask | Kropssammensætning