Lithium in Multiple System Atrophy (LAMU)

This study has been terminated.
(Data Monitoring Committee decision on 22nd August 2011 for safety issues)
Sponsor:
Information provided by (Responsible Party):
Alessandro Filla, Federico II University
ClinicalTrials.gov Identifier:
NCT00997672
First received: October 16, 2009
Last updated: December 17, 2013
Last verified: December 2013
  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
Drug: Placebo
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 ]
    Number of Adverse Events and their relative frequency in treatment groups was analyzed


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
Study Completion Date: August 2011
Primary Completion Date: August 2011 (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
Placebo comparator
Drug: Placebo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997672

Locations
Italy
Dipartimento di Scienze Neurologiche
Napoli, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Alessandro Filla, MD University Federico II
  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
Results First Received: March 6, 2013
Last Updated: December 17, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
MSA
Lithium
Lithium carbonate
MSA-P
MSA-C

Additional relevant MeSH terms:
Atrophy
Multiple System Atrophy
Shy-Drager Syndrome
Pathological Conditions, Anatomical
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
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 October 01, 2014