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A Pilot Study of Lithium in Progressive Multiple Sclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259388
First Posted: December 14, 2010
Last Update Posted: March 31, 2016
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.
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Lithium in Progressive Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Rate of change in brain parenchymal fraction [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Number of new gadolinium-enhancing brain MRI lesions [ Time Frame: 2 years ]
  • Number and volume of new T2-weighted brain MRI lesions [ Time Frame: 2 years ]
  • Number and volume of new T1-weighted hypointense brain MRI lesions [ Time Frame: 2 years ]

Estimated Enrollment: 20
Study Start Date: May 2011
Study Completion Date: December 2015
Primary Completion Date: August 2015 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Relapse or steroid treatment within 1 month of trial entry.
  • Any current or previous treatment with mitoxantrone, azathioprine, methotrexate, mycophenolate, cyclophosphamide, or any experimental therapy.
  • Women who are pregnant, wishing to become pregnant in the coming 30 months, or are breastfeeding.
  • Sexually active women unwilling to use reliable contraception (oral contraceptives, condom, IUD).
  • 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.
  • Patients with a history of unstable psychiatric illness or active severe depression.
  • Patients with a history of seizure.
  • Concurrent use of any of the following medications: Antipsychotics, diuretics, digoxin, or iodide salts.
  • Use of non-steroidal anti-inflammatory drugs (NSAIDs) 5 or more days a week.
  • Patients with a history of substance abuse in the past year.
  • Patients sensitive to gadolinium, or who are unable to undergo the required number of MRI scans.
  • Unable to speak or understand sufficient English to consent or complete study procedures.
  • Patients unable or unwilling to provide informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259388


Locations
United States, Alabama
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233
Kirklin Clinic
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: John R Rinker, MD Birmingham VA Medical Center, Birmingham, AL
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01259388     History of Changes
Other Study ID Numbers: CDA2-003-10S
First Submitted: December 10, 2010
First Posted: December 14, 2010
Last Update Posted: March 31, 2016
Last Verified: March 2016

Keywords provided by VA Office of Research and Development:
Multiple sclerosis
Lithium

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