Status:
COMPLETED
A Pilot Study of Lithium in Progressive Multiple Sclerosis
Lead Sponsor:
VA Office of Research and Development
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated, and effective at treating progressive forms of multiple sclerosis.
Detailed Description
In progressive multiple sclerosis (MS), patients experience worsening disability through a combination of inflammatory and neuro-degenerative processes. To test whether low-dose lithium carbonate amel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01259388
Start Date
May 1 2011
End Date
December 1 2015
Last Update
September 10 2019
Active Locations (2)
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1
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233
2
Kirklin Clinic
Birmingham, Alabama, United States, 35233