CompletedPhase 1/2

A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration

United States17 participantsStarted 2008-09

Plain-language summary

The goal of this trial is to evaluate the safety and tolerability of lithium in people with progressive supranuclear palsy or corticobasal degeneration.

Who can participate

Age range40 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Able to give informed consent
✓. Able to comply with the study protocol, including ability to attend follow-up study visits for the duration of the study
✓. Diagnosis of PSP or CBD based on the following criteria:
✓. Probable PSP:
✓. Probable CBD:
✓. If psychotropic or anti-parkinsonian medications are taken (e.g., anxiolytics, hypnotics, benzodiazepines, antidepressants, levodopa, amantadine), the dosage must be stable for 28 days prior to the screening visit and should be maintained at constant dosages throughout the study, as possible
✓. If NSAIDs, ACE-Is, ARBs, thiazide diuretics, COX-2 inhibitors or theophylline are taken by the subject, the dosage must be stable for 28 days prior to the screening visit and should be maintained at constant dosages throughout the study, as possible.
✓. Creatinine clearance \> 50 ml/min

Exclusion criteria

✕. Evidence of other diseases that could explain the clinical presentation
✕. History of known sensitivity or intolerability to lithium or to other known ingredients in the study drug
✕. Exposure to any investigational agent within 28 days of the screening visit
✕. Clinically significant cardiac disease or EKG findings
✕. Other serious illness, including psychiatric illness ("serious illness" is defined as an illness that is unstable enough that it might jeopardize the subject's ability to complete the study)
✕. Moderate to severe ongoing depression
✕. Family history of "PSP" or "CBS"
✕. Clinically significant abnormalities on the screening visit laboratory results

What they're measuring

Ability to Tolerate Lithium Carbonate

Timeframe: 28 weeks

Trial details

NCT IDNCT00703677

SponsorWestat

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-01

Results submitted2010-04-30

View on ClinicalTrials.gov More Progressive Supranuclear Palsy trials