Study of Pregabalin in the Prevention of Central Neuropathic Pain in Acute Spinal Cord Injury
Can Pregabalin Prevent the Development of Neuropathic Pain Following Spinal Cord Injury? A Double-Blind, Randomized, Placebo Controlled Trial.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Pregabalin is one of the few agents that have demonstrated effectiveness in the treatment of central NeP in SCI. Research is now proving that it is possible to prevent the development of pain in certain conditions. Pregabalin has been proven effective in this area with post surgical pain. Therefore, after traumatic SCI there may be a small window of time where we could prevent the development of NeP by administering an agent like Pregabalin.
Objective: To test the hypothesis that pregabalin is an effective treatment in preventing post-spinal cord injury neuropathic pain.
Design: double-blind, placebo controlled, randomized, trial Setting: Spinal cord injury program, neurosurgery and tertiary care rehabilitation center Subjects: 30 patients with acute traumatic spinal cord injury Method: Pregabalin will be offered to patients with acute traumatic spinal cord injury pain in a double blind crossover, placebo control design.
Main Outcome Measures: The primary outcome measures will be the development of Neuropathic Pain and intensity of pain Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.
Results: To be determined. Conclusion: To be determined.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3h 4K4
- N.S Rehabilitation Center ,Capital Health
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Eligible participants will be 18 years of age or older
- Have suffered a traumatic spinal cord injury (complete or incomplete)
- Be free of Neuropathic pain
- Be in stable medical condition
Exclusion Criteria:
- Pregnant or lactating women: Because we do not know the risks of pregabalin in pregnancy, females of child bearing years must have a negative pregnancy test (performed on screening and subsequent follow up visits) and be using a reliable method of birth control including oral or injectible birth control hormones, barriers, intrauterine devices or tubal ligation, or abstinence throughout the duration of the study.
- Should a female become pregnant while participating in the study she will be un-blinded and, if on pregabalin, she will be weaned from the medication as quickly as is safe and withdrawn from the study. Appropriate follow-up for any pregnancy complications will be conducted.
- Persons with known hypersensitivity to pregabalin or its constituents
- Persons with Neuropathic pain at the time of enrollment
- Persons with a chronic pain diagnoses that may interfere with the evaluation of the presence of Neuropathic pain
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Placebo-Komparator: Pregabalin, (other name) Lyrica
Study subjects wil be randomized to either the Pregabalin or Placebo group.
There is a 5o ,50 chance of being in either group.
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study participants will start will be on 150mg of Pregabalin or placebo capsules by mouth , twice a day.They will be on drug approx.
49 weeks and followed for another 49 weeks after stopping the medication.
Andere Namen:
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Placebo-Komparator: pregabalin, drug
study subjects that are randomized to the placebo group will receive matching placebo
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150 mg by mouth ,twice a day for 49 weeks
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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The primary outcome measures will be the development of Neuropathic Pain and intensity of pain .
Zeitfenster: the trial is 74 weeks in length
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the trial is 74 weeks in length
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.
Zeitfenster: trail is 74 weeks in length
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trail is 74 weeks in length
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Christine A. Short, Md FRCPC, Capital Health DHA Canada
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Schmerzen
- Neurologische Manifestationen
- Wunden und Verletzungen
- Neuromuskuläre Erkrankungen
- Erkrankungen des peripheren Nervensystems
- Trauma, Nervensystem
- Erkrankungen des Rückenmarks
- Neuralgie
- Verletzungen des Rückenmarks
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Depressiva des zentralen Nervensystems
- Agenten des peripheren Nervensystems
- Analgetika
- Agenten des sensorischen Systems
- Beruhigende Agenten
- Psychopharmaka
- Membrantransportmodulatoren
- Anti-Angst-Mittel
- Antikonvulsiva
- Calciumregulierende Hormone und Wirkstoffe
- Kalziumkanalblocker
- Pregabalin
Andere Studien-ID-Nummern
- Pregabalin and SCI-Short
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