A Pilot Study of Lithium in Progressive Multiple Sclerosis



Status:Completed
Conditions:Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:30 - 65
Updated:4/21/2016
Start Date:May 2011
End Date:December 2015

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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.


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.
We found this trial at
2
sites
Birmingham, Alabama 35233
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Birmingham, AL
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Birmingham, AL
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