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Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury

27. Juli 2017 aktualisiert von: Acorda Therapeutics

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

Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

204

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3A 1M4
        • Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Kanada, L8N 3Z5
        • Chedoke-McMaster Hospital
      • Kingston, Ontario, Kanada, K7L 5A2
        • St. Mary's of the Lake Hospital
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35233
        • UAB School of Medicine, 190 Spain Rehab Center
    • California
      • Long Beach, California, Vereinigte Staaten, 90822
        • Long Beach VA Medical Center
      • Sacramento, California, Vereinigte Staaten, 95817
        • University of California, Davis
      • San Jose, California, Vereinigte Staaten, 95128
        • Santa Clara Valley Medical Center
    • Colorado
      • Englewood, Colorado, Vereinigte Staaten, 80110
        • Craig Hospital
    • Connecticut
      • New Britain, Connecticut, Vereinigte Staaten, 06503
        • Hospital for Special Care
    • Illinois
      • Hines, Illinois, Vereinigte Staaten, 60141
        • Hines VA Hospital
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02118
        • Boston University Medical Center
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109
        • University of Michigan
      • Detroit, Michigan, Vereinigte Staaten, 48201
        • Rehabilitation Institute of Michigan
    • Minnesota
      • Minneapolis, Minnesota, Vereinigte Staaten, 55417
        • Minneapolis VA Hospital
    • Missouri
      • Columbia, Missouri, Vereinigte Staaten, 65212
        • University of Missouri
      • Saint Louis, Missouri, Vereinigte Staaten, 63104
        • St. Louis University
    • New York
      • Rochester, New York, Vereinigte Staaten, 14642
        • University of Rochester/Strong Memorial Hospital
      • Syracuse, New York, Vereinigte Staaten, 13045
        • SUNY Upstate Clinical Trials Office
      • West Haverstraw, New York, Vereinigte Staaten, 13045
        • Helen Hayes Hospital
    • North Carolina
      • Charlotte, North Carolina, Vereinigte Staaten, 28203
        • Charlotte Institute of Rehabilitation
      • Wilmington, North Carolina, Vereinigte Staaten, 28402
        • Coastal AHEC
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • Ohio State University
      • Dayton, Ohio, Vereinigte Staaten, 45409
        • Miami Valley Hospital- Rehabilitation Institute of Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19107
        • Thomas Jefferson University Hospital
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75216
        • VA North Texas Health Care System
      • Dallas, Texas, Vereinigte Staaten, 75390
        • Southwestern Medical Center at Dallas
    • Virginia
      • Falls Church, Virginia, Vereinigte Staaten, 22042
        • INOVA Institute of Research and Education
      • Richmond, Virginia, Vereinigte Staaten, 23298
        • Medical College of Virginia/VCU
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98195
        • University of Washington Medical Center, Dept. of Rehabilitation
    • Wisconsin
      • Milwaukee, Wisconsin, Vereinigte Staaten, 53295
        • Wood VA Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Arzneimittel: Placebo
Placebo
Aktiver Komparator: Fampridin-SR 50 mg/Tag
Arzneimittel: Fampridin-SR
25 mg 2-mal täglich (zweimal täglich)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Acorda Therapeutics

Ermittler

  • Studienleiter: Andrew Blight, MD, Acorda Therapeutics

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2002

Primärer Abschluss (Tatsächlich)

1. November 2003

Studienabschluss (Tatsächlich)

1. Februar 2004

Studienanmeldedaten

Zuerst eingereicht

24. August 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. September 2012

Zuerst gepostet (Schätzen)

12. September 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. August 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Juli 2017

Zuletzt verifiziert

1. Januar 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SCI-F302

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