A Pilot Study of Lithium in Progressive Multiple Sclerosis

NCT01259388 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CDA2-003-10S
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Lithium

Outcome Measures

Primary Outcomes (1)

• Rate of Change in Brain Parenchymal Fraction

  Paired comparison of change in brain parenchymal fraction during Lithium treatment and during observation period

  2 years

Secondary Outcomes (2)

• Total Relapses

  2 years

• Change in Expanded Disability Status Scale Score

  2 years

Study Arms (2)

Lithium

EXPERIMENTAL

Lithium-treatment phase Lithium Carbonate: Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time.

Drug: Lithium Carbonate

Observation

NO INTERVENTION

During observation subjects continue on their standard of care disease modifying agent (or no agent at all if judged not appropriate by the treating physician).

Interventions

Lithium Carbonate DRUG

Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time.

Also known as: Standard care (observation)

Lithium

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233, United States

Location

Kirklin Clinic

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• Rinker JR 2nd, Meador WR, King P. Randomized feasibility trial to assess tolerance and clinical effects of lithium in progressive multiple sclerosis. Heliyon. 2020 Jul 28;6(7):e04528. doi: 10.1016/j.heliyon.2020.e04528. eCollection 2020 Jul.

  PMID: 32760832 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Lithium Carbonate; Standard of Care; Observation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Methods; Investigative Techniques

Limitations and Caveats

This was a pilot study and thus by design was not powered to detect therapeutic differences. The primary purpose of the study was feasibility with the specified outcomes intended to generate preliminary data for subsequent research.

Results Point of Contact

• Title: Dr. John Rinker
• Organization: Birmingham VA Medical Center

John.Rinker@va.gov

205-934-2402

Study Officials

• John R Rinker, MD

  Birmingham VA Medical Center, Birmingham, AL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Each study participant agreed to a two-year enrollment commitment. Each subject was asked to take lithium for one year and to be observed for one year. Randomization was used to determine the sequence of lithium vs. observation (year 1 or year 2).

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 14, 2010
• Study Start: May 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 10, 2019
• Results First Posted: September 10, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)