Phase 2
N=23
A Pilot Study of Lithium in Progressive Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01259388 ↗Enrolled (actual)
23
Serious AEs
4.9%
Results posted
Sep 2019
Primary outcome: Primary: Rate of Change in Brain Parenchymal Fraction — 0.107; -0.355 percentage of change in brain volume — p=0.346
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lithium Carbonate (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Change in Brain Parenchymal Fraction |
0.107; -0.355 | 0.346 |
| SECONDARY Total Relapses |
2; 5 | — |
| SECONDARY Change in Expanded Disability Status Scale Score |
0; 0.5 | 0.013 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01259388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.