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A Pilot Study of Lithium in Progressive Multiple Sclerosis

This study is currently recruiting participants.
Verified December 2012 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01259388
First received: December 10, 2010
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated, and effective at treating progressive forms of multiple sclerosis.


Condition Intervention Phase
Multiple Sclerosis
 Drug: Lithium Carbonate
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Lithium in Progressive Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Rate of change in brain parenchymal fraction [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of new gadolinium-enhancing brain MRI lesions [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Number and volume of new T2-weighted brain MRI lesions [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Number and volume of new T1-weighted hypointense brain MRI lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
One year's treatment of standard therapy plus lithium followed by one year of standard therapy without lithium.
 Drug: Lithium Carbonate
Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time.
Experimental: Arm 2
One year's treatment with standard therapy followed by one year of standard therapy plus lithium.
 Drug: Lithium Carbonate
Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of a progressive subtype of multiple sclerosis by revised 2005 McDonald Criteria.
  2. EDSS of 3.0-6.5
  3. Ages 30-65
  4. Must be mentally capable of providing informed consent and following study guidelines.

Exclusion Criteria:

  1. Relapse or steroid treatment within 1 month of trial entry.
  2. Any current or previous treatment with mitoxantrone, azathioprine, methotrexate, mycophenolate, cyclophosphamide, or any experimental therapy.
  3. Women who are pregnant, wishing to become pregnant in the coming 30 months, or are breastfeeding.
  4. Sexually active women unwilling to use reliable contraception (oral contraceptives, condom, IUD).
  5. Patients with known kidney dysfunction or creatinine >1.4; known cardiac arrhythmia or significant conduction abnormality on EKG; uncontrolled thyroid disease or TSH >20% above the upper limit of normal; uncontrolled psoriasis, HIV, or any other severe medical condition.
  6. Patients with a history of unstable psychiatric illness or active severe depression.
  7. Patients with a history of seizure.
  8. Concurrent use of any of the following medications: Antipsychotics, diuretics, digoxin, or iodide salts.
  9. Use of non-steroidal anti-inflammatory drugs (NSAIDs) 5 or more days a week.
  10. Patients with a history of substance abuse in the past year.
  11. Patients sensitive to gadolinium, or who are unable to undergo the required number of MRI scans.
  12. Unable to speak or understand sufficient English to consent or complete study procedures.
  13. Patients unable or unwilling to provide informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259388

Contacts
Contact: John R Rinker, MD John.Rinker@va.gov

Locations
United States, Alabama
VA Medical Center, Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: John R Rinker, MD         John.Rinker@va.gov    
Principal Investigator: John R. Rinker, MD            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: John R. Rinker, MD VA Medical Center, Birmingham
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01259388     History of Changes
Other Study ID Numbers: CDA2-003-10S
Study First Received: December 10, 2010
Last Updated: December 5, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Multiple sclerosis
Lithium

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Lithium
Lithium Carbonate
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013