A Pilot Study of Lithium in Progressive Multiple Sclerosis
A Pilot Trial of Lithium in Progressive Multiple Sclerosis
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Rate of Change in Brain Parenchymal Fraction | 0.346 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Lithium carbonate
Glycogen synthase kinase-3 inhibitor|Inositol-1(or 4)-monophosphatase 1 inhibitor
Results by group
Rate of Change in Brain Parenchymal Fraction
2 years
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Lithium | 0.107 percentage of change in brain volume | 0.38 (Standard Error) | 17 |
| Observation | -0.355 percentage of change in brain volume | 0.22 (Standard Error) | 17 |
Lithium
Observation
p = 0.346
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Lithium | 23 | 1 (4.3%) | |
| Observation | 18 | 1 (5.6%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Rate of Change in Brain Parenchymal Fraction
2 years
Brain volume loss
Other measures (2)
Total Relapses
2 years
RelapsesChange in Expanded Disability Status Scale Score
2 years
Disability progressionVisionThinking and memoryBladder, bowel and sexual function
Who could take part
Progressive MS · 30 to 65 · EDSS 3.0 to 6.5
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated, and effective at treating progressive forms of multiple sclerosis.
Papers
Loading reviews and guidelines…
History
Started
May 2011
Main results due
Aug 2015
Finished
Dec 2015
Results posted
Sept 2019