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A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Westat
ClinicalTrials.gov Identifier:
NCT00703677
First received: June 20, 2008
Last updated: June 18, 2010
Last verified: August 2009
History of Changes
Results First Received: April 30, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Progressive Supranuclear Palsy
Corticobasal Degeneration
Intervention: Drug: Lithium

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The protocol was open for recruitment between September 2008 and August 24, 2009 at neurology clinics affiliated with university hospitals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable

Reporting Groups
  Description
Lithium Carbonate All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.

Participant Flow:   Overall Study
    Lithium Carbonate  
STARTED     17  
COMPLETED     14  
NOT COMPLETED     3  
Dropout-withdrawal not related to drug                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Lithium Carbonate All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.

Baseline Measures
    Lithium Carbonate  
Number of Participants  
[units: participants]
 		  17  
Age, Customized [1]
[units: participants]
 		 
40 - 49 years     0  
50 - 59 years     2  
60 - 69 years     9  
70 - 79 years     6  
Gender  
[units: participants]
 		 
Female     8  
Male     9  
Region of Enrollment  
[units: participants]
 		 
United States     16  
United Kingdom     1  
[1] Age at enrollment



  Outcome Measures
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1.  Primary:   Ability to Tolerate Lithium Carbonate   [ Time Frame: 28 weeks ]
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2.  Secondary:   Study Drug Compliance   [ Time Frame: 28 weeks ]
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3.  Secondary:   Changes in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF)   [ Time Frame: 28 weeks ]
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4.  Secondary:   Change in Brain-Derived Neurotrophic Factor (BDNF) in CSF   [ Time Frame: 28 weeks ]
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5.  Secondary:   Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity   [ Time Frame: 28 weeks ]
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6.  Secondary:   PSP Rating Scale Score: Change From Baseline   [ Time Frame: 28 weeks ]
Results not yet posted.   Anticipated Posting Date:   01/2011   Safety Issue:   No

7.  Secondary:   Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline   [ Time Frame: 28 weeks ]
Results not yet posted.   Anticipated Posting Date:   01/2011   Safety Issue:   No

8.  Secondary:   PSP-Quality of Life Scale (QoL):Change From Baseline   [ Time Frame: 28 weeks ]
Results not yet posted.   Anticipated Posting Date:   01/2011   Safety Issue:   No

9.  Secondary:   Frontal Assessment Battery (FAB): Change From Baseline   [ Time Frame: 28 weeks ]
Results not yet posted.   Anticipated Posting Date:   01/2011   Safety Issue:   No

10.  Secondary:   Geriatric Depression Scale(GDS)-15:Change From Baseline   [ Time Frame: 28 weeks ]
Results not yet posted.   Anticipated Posting Date:   01/2011   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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
The majority of subjects did not tolerate study drug, therefore, evaluations of subjects on study drug are limited in number.  


Results Point of Contact:  
Name/Title: René Gonin, PhD (Math. Stats.)
Organization: Westat
phone: 301-251-1500
e-mail: renegonin@westat.com


No publications provided


Responsible Party: Renè Gonin, Ph.D. (Math. Stats.), Principal Investigator, and Senior Biostatistician, Westat
ClinicalTrials.gov Identifier: NCT00703677     History of Changes
Other Study ID Numbers: NPTUNE_PSP_CBD, HHSN265200423611C
Study First Received: June 20, 2008
Results First Received: April 30, 2010
Last Updated: June 18, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board