- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1M4
- Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- Chedoke-McMaster Hospital
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Kingston, Ontario, Canada, K7L 5A2
- St. Mary's of the Lake Hospital
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- UAB School of Medicine, 190 Spain Rehab Center
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California
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Long Beach, California, États-Unis, 90822
- Long Beach VA Medical Center
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Sacramento, California, États-Unis, 95817
- University of California, Davis
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San Jose, California, États-Unis, 95128
- Santa Clara Valley Medical Center
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Colorado
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Englewood, Colorado, États-Unis, 80110
- Craig Hospital
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Connecticut
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New Britain, Connecticut, États-Unis, 06503
- Hospital for Special Care
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Illinois
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Hines, Illinois, États-Unis, 60141
- Hines VA Hospital
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Massachusetts
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Boston, Massachusetts, États-Unis, 02118
- Boston University Medical Center
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan
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Detroit, Michigan, États-Unis, 48201
- Rehabilitation Institute of Michigan
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55417
- Minneapolis VA Hospital
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Missouri
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Columbia, Missouri, États-Unis, 65212
- University of Missouri
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Saint Louis, Missouri, États-Unis, 63104
- St. Louis University
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New York
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Rochester, New York, États-Unis, 14642
- University of Rochester/Strong Memorial Hospital
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Syracuse, New York, États-Unis, 13045
- SUNY Upstate Clinical Trials Office
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West Haverstraw, New York, États-Unis, 13045
- Helen Hayes Hospital
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North Carolina
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Charlotte, North Carolina, États-Unis, 28203
- Charlotte Institute of Rehabilitation
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Wilmington, North Carolina, États-Unis, 28402
- Coastal AHEC
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Ohio
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Columbus, Ohio, États-Unis, 43210
- Ohio State University
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Dayton, Ohio, États-Unis, 45409
- Miami Valley Hospital- Rehabilitation Institute of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107
- Thomas Jefferson University Hospital
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Texas
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Dallas, Texas, États-Unis, 75216
- VA North Texas Health Care System
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Dallas, Texas, États-Unis, 75390
- Southwestern Medical Center at Dallas
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Virginia
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Falls Church, Virginia, États-Unis, 22042
- INOVA Institute of Research and Education
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Richmond, Virginia, États-Unis, 23298
- Medical College of Virginia/VCU
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Washington
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Seattle, Washington, États-Unis, 98195
- University of Washington Medical Center, Dept. of Rehabilitation
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53295
- Wood VA Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Placebo
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Placebo
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Comparateur actif: fampridine-SR 50mg/jour
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25mg bid (deux fois par jour)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores
Délai: 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
Délai: 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
Délai: 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
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Change From Baseline in Mean International Index of Erectile Function (IIEF) Score
Délai: 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
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Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores
Délai: Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98
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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
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Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores
Délai: Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98
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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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Andrew Blight, MD, Acorda Therapeutics
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux central
- Maladies du système nerveux
- Manifestations neurologiques
- Maladies musculo-squelettiques
- Maladies musculaires
- Manifestations neuromusculaires
- Traumatisme, système nerveux
- Maladies de la moelle épinière
- Hypertonie musculaire
- Blessures et Blessures
- Blessures à la moelle épinière
- Spasticité musculaire
- Mécanismes moléculaires de l'action pharmacologique
- Modulateurs de transport membranaire
- Bloqueurs des canaux potassiques
- 4-Aminopyridine
Autres numéros d'identification d'étude
- SCI-F302
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