Trial Outcomes & Findings for Lithium in Multiple System Atrophy (NCT NCT00997672)
NCT ID: NCT00997672
Last Updated: 2014-02-03
Results Overview
Number of Adverse Events and their relative frequency in treatment groups was analyzed
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
the endpoint will be recorded at all visits
Results posted on
2014-02-03
Participant Flow
Patients were recruited through our outpatient clinic. Recruitment started the 4th June 2010 and the trial was stopped the 22nd of August 2011
Patients were screened prior to randomization, no patients were excluded.
Participant milestones
| Measure |
Lithium CARBONATE 150 or 300 mg
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.
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lithium in Multiple System Atrophy
Baseline characteristics by cohort
| Measure |
Lithium CARBONATE 150 or 300 mg
n=4 Participants
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.
|
Placebo
n=5 Participants
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.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 5 • n=5 Participants
|
64 years
STANDARD_DEVIATION 6 • n=7 Participants
|
64 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: the endpoint will be recorded at all visitsNumber of Adverse Events and their relative frequency in treatment groups was analyzed
Outcome measures
| Measure |
Lithium CARBONATE 150 or 300 mg
n=4 Participants
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.
|
Placebo
n=5 Participants
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.
|
|---|---|---|
|
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.
|
58 number of AEs
|
21 number of AEs
|
SECONDARY outcome
Timeframe: 0 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
Outcome data not reported
Adverse Events
Lithium CARBONATE 150 or 300 mg
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lithium CARBONATE 150 or 300 mg
n=4 participants at risk
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.
|
Placebo
n=5 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Death
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Cardiac disorders
Cardiovascular failure
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infection
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Fever
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Inguinal abscess
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
Other adverse events
| Measure |
Lithium CARBONATE 150 or 300 mg
n=4 participants at risk
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.
|
Placebo
n=5 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Lower limbs weakness
|
75.0%
3/4 • Number of events 4
|
60.0%
3/5 • Number of events 5
|
|
Nervous system disorders
sleepiness
|
25.0%
1/4 • Number of events 4
|
40.0%
2/5 • Number of events 5
|
|
Renal and urinary disorders
Incontinence
|
25.0%
1/4 • Number of events 4
|
60.0%
3/5 • Number of events 5
|
|
Renal and urinary disorders
Cystitis
|
50.0%
2/4 • Number of events 4
|
20.0%
1/5 • Number of events 5
|
|
Gastrointestinal disorders
diarrhea
|
50.0%
2/4 • Number of events 4
|
40.0%
2/5 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
joint rigidity
|
50.0%
2/4 • Number of events 4
|
20.0%
1/5 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
pulmonitis
|
25.0%
1/4 • Number of events 4
|
20.0%
1/5 • Number of events 5
|
|
Gastrointestinal disorders
gastroaesophageal reflux
|
25.0%
1/4 • Number of events 4
|
40.0%
2/5 • Number of events 5
|
Additional Information
Dr. Francesco Saccà
University Federico II, Naples, Italy
Phone: 3470734774
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place