Trial record 1 of 2 for:    lithium multiple sclerosis
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A Pilot Study of Lithium in Progressive Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01259388
First received: December 10, 2010
Last updated: November 5, 2013
Last verified: November 2013

December 10, 2010
November 5, 2013
May 2011
June 2016   (final data collection date for primary outcome measure)
Rate of change in brain parenchymal fraction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01259388 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Pilot Study of Lithium in Progressive Multiple Sclerosis
A Pilot Trial of Lithium in Progressive Multiple Sclerosis

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
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 1
    One year's treatment of standard therapy plus lithium followed by one year of standard therapy without lithium.
    Intervention: Drug: Lithium Carbonate
  • Experimental: Arm 2
    One year's treatment with standard therapy followed by one year of standard therapy plus lithium.
    Intervention: Drug: Lithium Carbonate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2016
June 2016   (final data collection date for primary outcome measure)

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.
Both
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01259388
CDA2-003-10S
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: John R. Rinker, MD VA Medical Center, Birmingham
Department of Veterans Affairs
November 2013

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