NCT02446977

Brief Summary

Administration of CBG000592 (riboflavin/vitamin B2) in patients with acute ischemic stroke to know if it causes a reduction of glutamate-mediated excitotoxicity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

April 21, 2015

Last Update Submit

October 12, 2016

Conditions

Ischemic Stroke

Keywords

ischemicstrokevitamin B2

Outcome Measures

Primary Outcomes (1)

  • Reduction of serum glutamate concentration

    Difference between serum glutamate concentration from basal (prior to medication infusion) and levels at 3 ± 1 and 6 ± 1 hours, from administered medication, including branch CBG000592 (riboflavin/vitamin B2) and placebo.

    7 hours

Secondary Outcomes (6)

  • Days of hospitalisation

    3 months

  • Percentage of clinical improvement (basal-high)

    3 months

  • Functional outcome using Rankin Scale at 90 days

    3 months

  • Serum glutamate concentrations

    7 hours

  • Prognosis of patients using Rankin Scale at 90 days

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Vitamin B2 Streuli®

EXPERIMENTAL

20mg IV

Drug: Vitamin B2 Streuli®

Solution for injection

PLACEBO COMPARATOR

4ml IV

Other: Solution for injection

Interventions

Vitamin B2 Streuli®DRUG

4ml IV

Also known as: CBG000592
Vitamin B2 Streuli®
Solution for injectionOTHER

4ml IV

Also known as: Placebo Comparator
Solution for injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 years, both men and women.
  • Patient or legal representative able to understand and sign the informed consent.
  • Patients with suspected stroke within 3 hours of onset.

You may not qualify if:

  • Women of childbearing age, with potential for pregnancy or breastfeeding.
  • Patients with a score ≥ 2 point 1a in the NIHSS scale.
  • Scale pre-stroke modified Rankin ≥ 2.
  • Inability to prior testing image needed for the study.
  • Previous disorders that may interfere with the interpretation of neurological scales.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

MeSH Terms

Conditions

Ischemic StrokeIschemiaStroke

Interventions

SolutionsInjections

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • José Castillo, MD

    Complejo Hospitalario Universitario de Santiago

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

May 18, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

ES(1)