Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effectiveness of Amantadine Hydrochloride for Treatment of Severe Traumatic Brain Injury (TBI)

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Joseph T Giacino, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT00970944
First received: September 2, 2009
Last updated: September 11, 2012
Last verified: September 2012
Results First Received: December 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Traumatic Brain Injury
Interventions: Drug: Amantadine Hydrochloride
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
February 23,2003 through March 15, 2010. Eleven rehabilitations centers in the USA (8) and Europe (3)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Amantadine HCL 100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
Placebo Visually identical compound administered in the same manner (ie enterally) as the actual study drug.

Participant Flow:   Overall Study
    Amantadine HCL     Placebo  
STARTED     87     97  
COMPLETED     86     95  
NOT COMPLETED     1     2  
Death                 1                 0  
Physician Decision                 0                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Amantadine HCL 100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
Placebo Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
Total Total of all reporting groups

Baseline Measures
    Amantadine HCL     Placebo     Total  
Number of Participants  
[units: participants]
  87     97     184  
Age  
[units: participants]
     
<=18 years     5     1     6  
Between 18 and 65 years     82     96     178  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  35.5  ± 15.3     37.2  ± 15.4     36.4  ± 15.4  
Gender  
[units: participants]
     
Female     23     28     51  
Male     64     69     133  
Region of Enrollment  
[units: participants]
     
United States     61     73     134  
Denmark     3     2     5  
Germany     23     22     45  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Disability Rating Scale: Functional Status   [ Time Frame: Randomization and weekly for 6 weeks. The primary study endpoint was week 4 and drug washout was week 6. ]

2.  Secondary:   JFK Coma Recovery Scale-Revised: Neurobehavioral Status   [ Time Frame: Week 4 (primary endpoint); Week 6 (post-washout) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Joseph T Giacino, PhD
Organization: Spaulding Rehabilitation Hospital
phone: 617-573-2757
e-mail: jgiacino@partners.org


No publications provided by JFK Medical Center

Publications automatically indexed to this study:

Responsible Party: Joseph T Giacino, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT00970944     History of Changes
Other Study ID Numbers: H133A031713
Study First Received: September 2, 2009
Results First Received: December 12, 2011
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board