Lithium in Multiple System Atrophy (LAMU)
This study has been terminated.
(Data Monitoring Committee decision on 22nd August 2011 for safety issues)
Sponsor:
Federico II University
Information provided by (Responsible Party):
Alessandro Filla, Federico II University
ClinicalTrials.gov Identifier:
NCT00997672
First received: October 16, 2009
Last updated: December 19, 2011
Last verified: December 2011
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Purpose
The purpose of this study is to determine safety and tolerability of the treatment with lithium in Multiple System Atrophy. Moreover, clinical symptoms, neuronal loss, quality of life and depressive symptoms, will be considered to further investigate the effect of lithium therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple System Atrophy |
Drug: Lithium Carbonate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Tolerability of Lithium in Multiple System Atrophy. |
Resource links provided by NLM:
Further study details as provided by Federico II University:
Primary Outcome Measures:
- Primary endpoint of the study will be the difference in number and relative frequency of Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) recorded during the study, between treatment and placebo group. [ Time Frame: the endpoint will be recorded at all visits ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Secondary outcome will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical analysis will be performed to compare the effect of treatment on both groups. [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]
- Micro- and macrostructural Magnetic Resonance parameters will be compared before and after treatment. This will include Voxel Based Morphometry, resting functional MRI, Diffusion tensor imaging and MRI spectroscopy. [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]
- The effect of Lithium on mood will be explored with the Beck depression inventory. [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]
- Effect of Lithium on quality of life will be assessed with the EQ-5D scale. [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]
- Secondary outcome will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical analysis will be performed to compare the effect of treatment on both groups. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Secondary outcome will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical analysis will be performed to compare the effect of treatment on both groups. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Micro- and macrostructural Magnetic Resonance parameters will be compared before and after treatment. This will include Voxel Based Morphometry, resting functional MRI, Diffusion tensor imaging and MRI spectroscopy. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- The effect of Lithium on mood will be explored with the Beck depression inventory. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- The effect of Lithium on mood will be explored with the Beck depression inventory. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Effect of Lithium on quality of life will be assessed with the EQ-5D scale. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Effect of Lithium on quality of life will be assessed with the EQ-5D scale. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lithium CARBONATE 150 and/or 300 mg |
Drug: Lithium Carbonate
Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
Other Name: Lithium carbonate
|
| Placebo Comparator: Placebo |
Drug: Lithium Carbonate
Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
Other Name: Lithium carbonate
|
Detailed Description:
Patients will be progressively enrolled in the study and undergo a screening visit to test for inclusion/exclusion criteria. Patients will then be randomized to receive either Lithium carbonate or placebo. Patients will visit study center at 2, 4, 8, 12, 24, 36 and 48 weeks, for endpoint and laboratory assessments.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of probable MSA (Gilman, et al. 2008)
- Age ≥18, <80
Exclusion Criteria:
- Heart failure
- Liver disease
- Kidney failure
- Thyroid disease
- Sick sinus syndrome and/or significant ECG alterations
- Hyposodemia
- Treatment with diuretics
- Treatment with haloperidol and/or other antipsychotics
- Treatment with NSAIDs or corticosteroids
- Treatment with ACE inhibitors
- Treatment with aminophyllines
- Treatment with mannitol
- Pregnancy and/or breastfeeding
- Acute diseases that might interfere with the trial
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Alessandro Filla, Principal Investigator, Federico II University |
| ClinicalTrials.gov Identifier: | NCT00997672 History of Changes |
| Other Study ID Numbers: | MSA_LITIO_13, Eudract n°2009−016377−15 |
| Study First Received: | October 16, 2009 |
| Last Updated: | December 19, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Federico II University:
|
MSA Lithium Lithium carbonate MSA-P MSA-C |
Additional relevant MeSH terms:
|
Multiple System Atrophy Shy-Drager Syndrome Atrophy Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Neurodegenerative Diseases Hypotension Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical |
Lithium Lithium Carbonate Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Antimanic Agents Antidepressive Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013