Status:
COMPLETED
Lithium Treatment for Patients With Spinocerebellar Ataxia Type I
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Spinocerebellar Ataxia Type I
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will evaluate the side effects and tolerability of the drug lithium in patients with spinocerebellar ataxia type I (SCA1) an inherited disorder caused by loss of nerve cells in parts of the...
Detailed Description
Objective Evaluation of tolerability and safety of lithium in SCA1 patients. Study Population A total of 10 molecularly diagnosed SCA1 patients divided in two groups. One group would be composed of...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 18-65 years of age
- Molecularly diagnosed SCA1
- Gait disturbance only or gait disturbance and tremor and/or hand incoordination and/or speech difficulty.
- Women of childbearing age who agree to use contraceptive methods for the duration of the study.
- EXCLUSION CRITERIA:
- Children
- Pregnant or nursing women
- Anyone on a low-sodium diet
- Cognitively impaired individuals
- Schizophrenics
- Family history of thyroid diseases
- Patients with medical conditions that can be affected by Lithium such as diabetes mellitus, difficulty urinating, infections (severe occurring with fever, prolonged sweating, diarrhea, or vomiting), kidney disease, epilepsy, thyroid disease, heart disease, pulmonary disease, bipolar affective disorder, cardiac arrhythmia, diabetes insipidus, Parkinson disease, psoriasis and leukemia.
- Anyone taking the following medications: diuretics, nonsteroidal anti-inflammatory agents, methyldopa, tetracycline, antipsychotic, neuromuscular blocking agents, digoxin, phenytoin, acetazolamide, calcium iodide, iodinated glycerol, potassium iodide, calcium channel blockers and/or metronidazole. Patients on these medications may be enrolled and their lithium levels will be followed very closely. If levels are consistently maintained, the subject may remain in the study.
- Age greater than 65 years
Exclusion
Key Trial Info
Start Date :
May 18 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00683943
Start Date
May 18 2008
End Date
February 25 2010
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892