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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3h 4K4
- N.S Rehabilitation Center ,Capital Health
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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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.
Andre navne:
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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The primary outcome measures will be the development of Neuropathic Pain and intensity of pain .
Tidsramme: the trial is 74 weeks in length
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the trial is 74 weeks in length
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.
Tidsramme: trail is 74 weeks in length
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trail is 74 weeks in length
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Christine A. Short, Md FRCPC, Capital Health DHA Canada
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 (Skøn)
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
- Smerte
- Neurologiske manifestationer
- Sår og skader
- Neuromuskulære sygdomme
- Sygdomme i det perifere nervesystem
- Traumer, nervesystemet
- Rygmarvssygdomme
- Neuralgi
- Rygmarvsskader
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Beroligende midler
- Psykotropiske stoffer
- Membrantransportmodulatorer
- Anti-angst midler
- Antikonvulsiva
- Calciumregulerende hormoner og midler
- Calciumkanalblokkere
- Pregabalin
Andre undersøgelses-id-numre
- Pregabalin and SCI-Short
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