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Trial record 8 of 140 for:    AMANTADINE

Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02566720
Recruitment Status : Unknown
Verified December 2015 by Hamilton Health Sciences Corporation.
Recruitment status was:  Not yet recruiting
First Posted : October 2, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

Tracking Information
First Submitted Date  ICMJE September 23, 2015
First Posted Date  ICMJE October 2, 2015
Last Update Posted Date December 11, 2015
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2015)
Radiographic Changes [ Time Frame: At baseline and ninety days or at time of discharge from hospital if occurs earlier. ]
MRI Tractography will be performed to measure the size the of reticular activating system fiber tracts. Specifically, the tracts that project through the posterior thalamus.
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
MRI Tractography [ Time Frame: At ninety days or at time of discharge from hospital if occurs earlier. ]
Size of reticular activating system fiber tracts on MRI tractography studies, specifically the tracts that project through the posterior thalamus.
Change History Complete list of historical versions of study NCT02566720 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
Functional Improvement [ Time Frame: At ninety days or at time of discharge from hospital if occurs earlier. ]
Disability Rating Scale Score (at enrolment and at completion of the study).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study
Official Title  ICMJE Mechanism of Amantadine and Functional Improvement Following Acquired Brain Injury as Measured by MRI Tractography; A Pilot Study
Brief Summary This is a pilot study. The objective is to further understand the mechanism by which amantadine improves function in patients with persistent vegetative state and minimally conscious state. Specifically, the investigators will measure the size of the nerve fibers that mediate arousal (reticular activating system, or RAS) pre and post treatment on MRI tractography. MRI findings will be correlated with the Disability Rating Scale (DRS) score. The information gathered from this study will be used to formulate a larger clinical trial.
Detailed Description

Primary Aim:

To determine the size of the RAS tracts as measured by MRI tractography. Specifically, the investigators will be measuring the fiber tracts that project through the posterior thalamus. The RAS is involved in mediating arousal and consciousness. The size of fiber tracts will be measured prior to initiating treatment and near the time of discharge from the rehabilitation hospital or at approximately ninety-days. It is hypothesized that treatment will result in an increase in the size of these fiber tracts.

As a pilot study, the investigators will be determining the feasibility of recruiting and retaining patients in this type of study. This will allow the clarification and understanding of the technical standards for MRI tractography related to the assessment of the reticular activating system.

Secondary Aim:

To determine and monitor changes in function following acquired brain injury as measured by the Disability Rating Scale (DRS) score. The DRS score will be obtained prior to initiating treatment and at termination of the study. It is hypothesized that treatment with amantadine in addition to standard medical treatment, will be associated with an improvement in function.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Acquired Brain Injury
  • Coma
  • Persistent Vegetative State
  • Minimally Conscious State
  • Traumatic Brain Injury
Intervention  ICMJE
  • Drug: Amantadine
    Participants will initially receive amantadine at the starting dose of 50mg twice daily either by mouth or feeding tube. The dosage will increase every week by 50mg twice daily (100mg total dose increase) up to the target dose of 200mg twice daily. These are the usual doses and rate of increase that are offered to patients with brain injury.
    Other Name: amantadine hydrochloride
  • Procedure: MRI Tractography Study
    Participants will initially receive a baseline MRI Tractography scan. The size of RAS fiber tracts will be measured prior to initiating treatment and near the time of discharge from the rehabilitation hospital or at approximately ninety-days.
Study Arms  ICMJE Treatment and MRI scanning
After informed consent has been obtained, the subjects will be examined by a physician and assigned a Disability Ratings Scale (DRS) score. Subjects will undergo MRI tractography study, which does not require the administration of contrast. All participants will receive oral amantadine at escalating doses to ensure tolerance (50mg twice daily for 7 days, then 100mg twice daily for 1 week, then 150mg twice daily, then 200mg twice daily). The usual length of stay on the inpatient brain injury program is ninety days. The MRI tractography study and DRS score will be repeated near the time of discharge or ninety days from enrollment.
Interventions:
  • Drug: Amantadine
  • Procedure: MRI Tractography Study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 30, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 years - 65 years
  • Nonpenetrating acquired brain injury (ABI)
  • Persistent vegetative or minimally conscious state (as indicated by DRS score greater than 11)
  • Consent from substitute decision maker

Exclusion Criteria:

  • Contraindication to MRI (such as metal in the body, pacemaker, implanted nerve stimulator)
  • Anticipated neurosurgical intervention
  • Medical instability including uncontrolled hypertension, fever, or infection
  • Seizure disorder prior to acquired brain injury or uncontrolled seizures subsequent to acquired brain injury
  • Parkinson's disease
  • History of heart failure or pre-existing peripheral oedema
  • History of eczematoid dermatitis
  • History of angle-closure glaucoma
  • History of neuroleptic malignant syndrome
  • Current treatment with Amantadine
  • Impairment related to other neurologic disease other than ABI
  • Allergy to Amantadine
  • Pregnancy or lactation
  • Impairment of renal function (creatinine clearance less than 60ml/min)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02566720
Other Study ID Numbers  ICMJE 0452
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hamilton Health Sciences Corporation
Study Sponsor  ICMJE Hamilton Health Sciences Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pankaj E Bansal, MD Hamilton Health Sciences Corporation
Principal Investigator: Seyed Hosseini, MD Hamilton Health Sciences Corporation
PRS Account Hamilton Health Sciences Corporation
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP