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Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction

7. mai 2013 oppdatert av: Xijing Hospital

A Random, Double-blind, Placebo- Controlled and Dose-finding, Multi-center, Phase II Clinical Trial of Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction

Using placebo as control, The purpose of this study is to evaluate the efficacy and safety of methanesulfonic acid cinepazide injection to relieve disabled degree of acute cerebral infarction patients, and explore the best safe and effective dose as well as dose method.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The study will enroll 288 acute cerebral infarction patients. Patients will be assigned randomly to receive either Methanesulfonic acid cinepazide injection or placebo treatment. All patient in the study will receive standard of care treatment and clinical, diagnostic, laboratory, safety, and follow-up evaluations. Follow-up evaluations, including National Institute of Health stroke scale(NIHSS), Barthel index score and modified Rankin scale assessments, will be done periodically until 90 days after onset. The degree of disabled improved will be a primary measure of drug effectiveness.

Studietype

Intervensjonell

Registrering (Forventet)

288

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710032
        • Xijing Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Age between 40 and 75 years old，male/ female；
  2. The clinical diagnosis of first onset patients with anterior circulation infarction or who have suffered from stroke in history and complete recover from neurologic impairment (mRS score <2 before this disease）
  3. Patients is proved by head skull CT and cerebral hemorrhage was excluded；
  4. course of disease≤72h，the NIHSS score is ≥7 and ≤22；
  5. Patients who voluntarily sign written informed consent. -

Exclusion Criteria:

  1. Patients who suffer from cerebral infarction accompanied by disorder of consciousness, posterior circulation infarction, lacunar infarction and transient ischemic attack.
  2. Patients who suffer from brain arteritis, brain tumor, brain injury, intracranial infection, brain parasitic disease, and so on . Patients who suffer from cardiac diseases such as rheumatic heart disease, coronary heart disease with atrial fibrillation .
  3. Patients who suffer from severe complications, and expected survival period is within three months.
  4. Patients require thrombolysis, anticoagulation, anti- fibrosis treatment .
  5. Patients who suffer from serious brain artery stenosis that should go through interventional therapy .
  6. Patients whose white blood cells or neutrophils is below the lower limit of the normal reference value .
  7. Patients who have bleeding tendency or suffered from serious bleeding in 3 months.
  8. Patients who have severe cardiac, liver and kidney disease, or whose kidney and liver function tests was abnormal（ALT,AST≥1.5 times of upper normal limit，Cr>upper normal limit）.
  9. Patients who have complications of malignant tumor, serious or progressive disease in blood, digestion or other system.
  10. Patients who have complications of mental illness un can not or do not want willing to cooperate .
  11. Doubt or does have alcohol, drug abuse history
  12. Allergic constitution or allergic to the test drug ingredients .
  13. Pregnancy and lactation women or those who has a recent fertility plan
  14. Patients who have participated in other clinical experiments three months before this test.
  15. The patients who is unsuitable to participate in the clinical test in the view of researchers

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cinepazide, Stroke, Injection
Test drug：Methanesulfonic acid cinepazide injection（5ml/125mg）
Legemiddel: cinepazide

2 branches of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day.

1 branch of simulation agent of Methanesulfonic acid cinepazide injection was matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day.

Andre navn:
  • Methanesulfonic acid cinepazide injection
Placebo komparator: palcebo,Stroke,Injection
Placebo：simulation agent of Methanesulfonic acid cinepazide injection（5ml sterile water for injection）
Legemiddel: placebo

2 branches of simulation agent of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day.

1 branch of simulation agent of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day.

Andre navn:
  • simulation agent of Methanesulfonic acid cinepazide

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
modified Rankin scale
Tidsramme: 3 month
3 month

Sekundære resultatmål

Resultatmål
Tidsramme
Barthel index
Tidsramme: 3 month
3 month

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Xijing Hospital

Etterforskere

  • Hovedetterforsker: Gang Zhao, Doctor, Xijing Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2013

Primær fullføring (Forventet)

1. august 2014

Studiet fullført (Forventet)

1. august 2014

Datoer for studieregistrering

Først innsendt

7. mai 2013

Først innsendt som oppfylte QC-kriteriene

7. mai 2013

Først lagt ut (Anslag)

10. mai 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

10. mai 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mai 2013

Sist bekreftet

1. mai 2013

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • xijing005

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