Trial Outcomes & Findings for Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS) (NCT NCT00818389)
NCT ID: NCT00818389
Last Updated: 2011-04-19
Results Overview
ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 \& 52, dependent on enrollment duration. Number of subjects who failed by treatment group was evaluated. Failure was defined as 6-point drop in ALSFRS-R or death from baseline.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
84 participants
Primary outcome timeframe
9 months: Baseline to study termination (January 2009 - October 2009)
Results posted on
2011-04-19
Participant Flow
Between January 2009 to June 2009, 97 patients were screened and 84 subjects were randomized at 21 clinical sites; 11 in the United States and 10 in Canada. All sites were members of the Northeast ALS Consortium (NEALS) and/or the Canadian ALS Consortium (CALS).
All patients were required to be on a stable dose of riluzole for at least 30 days prior to screening. 13 subjects failed screening: 3 due to low lung function test results, 3 due to prohibited medications,3 due to study closure, 2 due to abnormal lab test results and 1 due to death unrelated to the study.
Participant milestones
| Measure |
Lithium + Riluzole
Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
|
Placebo + Riluzole
Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
44
|
|
Overall Study
COMPLETED
|
36
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Lithium + Riluzole
Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
|
Placebo + Riluzole
Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
|
|---|---|---|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
ALS Disease Progression
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
Baseline characteristics by cohort
| Measure |
Lithium + Riluzole
n=40 Participants
Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
|
Placebo + Riluzole
n=44 Participants
Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.3 Years
STANDARD_DEVIATION 10.2 • n=93 Participants
|
55.5 Years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
56.24 Years
STANDARD_DEVIATION 11.16 • n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
ALS Functional Rating Scale-Revised (ALSFRS-R)
|
38.4 Scores on a scale
STANDARD_DEVIATION 4.6 • n=93 Participants
|
36.5 Scores on a scale
STANDARD_DEVIATION 5.7 • n=4 Participants
|
37.43 Scores on a scale
STANDARD_DEVIATION 5.24 • n=27 Participants
|
|
Vital Capacity
|
94.0 Percent of predicted normal
STANDARD_DEVIATION 18.1 • n=93 Participants
|
86.9 Percent of predicted normal
STANDARD_DEVIATION 16.9 • n=4 Participants
|
90.18 Percent of predicted normal
STANDARD_DEVIATION 18.20 • n=27 Participants
|
PRIMARY outcome
Timeframe: 9 months: Baseline to study termination (January 2009 - October 2009)ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 \& 52, dependent on enrollment duration. Number of subjects who failed by treatment group was evaluated. Failure was defined as 6-point drop in ALSFRS-R or death from baseline.
Outcome measures
| Measure |
Lithium + Riluzole
n=40 Participants
Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
|
Placebo + Riluzole
n=44 Participants
Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
|
|---|---|---|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R)
|
18 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 9 months: Baseline to study termination (January 2009 - October 2009)ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 \& 52, dependent on enrollment duration. Secondary efficacy was evaluated by comparing the mean rate of decline of ALSFRS-R score by treatment group.
Outcome measures
| Measure |
Lithium + Riluzole
n=40 Participants
Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
|
Placebo + Riluzole
n=44 Participants
Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
|
|---|---|---|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire(ALSFRS-R)
|
-1.24 Scores on a scale
Standard Error 0.21
|
-1.09 Scores on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: 9 months: Baseline to study termination (January 2009- October 2009)Secondary efficacy was measured by comparing the rate of decline of mean VC by treatment group.
Outcome measures
| Measure |
Lithium + Riluzole
n=40 Participants
Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
|
Placebo + Riluzole
n=44 Participants
Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
|
|---|---|---|
|
Vital Capacity (VC) (Percent of Predicted Normal)
|
-1.89 Percent of predicted normal
Standard Error 0.45
|
-3.12 Percent of predicted normal
Standard Error 0.47
|
Adverse Events
Lithium + Riluzole
Serious events: 10 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo + Riluzole
Serious events: 8 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lithium + Riluzole
n=40 participants at risk
Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
|
Placebo + Riluzole
n=44 participants at risk
Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign tumor
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
0.00%
0/44 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/40 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Cardiac disorders
Cardiac arrest
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
0.00%
0/44 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Cardiac disorders
Cardiac pain
|
0.00%
0/40 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
2.5%
1/40 • Number of events 2 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
0.00%
0/44 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
General disorders
Chest/thorax pain
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
0.00%
0/44 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Psychiatric disorders
Depression
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
0.00%
0/44 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
4.5%
2/44 • Number of events 4 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Encephalopathy
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
0.00%
0/44 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Fall
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
0.00%
0/44 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Hemorrhage, CNS
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
0.00%
0/44 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Infections and infestations
Pneumonia
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/40 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Eye disorders
Retro-orbital pain
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
0.00%
0/44 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/40 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Speech impairment/dysphagia
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
0.00%
0/44 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Syncope/fainting
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
0.00%
0/44 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Vascular disorders
Thrombosis/embolism
|
2.5%
1/40 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
Other adverse events
| Measure |
Lithium + Riluzole
n=40 participants at risk
Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
|
Placebo + Riluzole
n=44 participants at risk
Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
|
|---|---|---|
|
Gastrointestinal disorders
Anorexia
|
15.0%
6/40 • Number of events 7 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
4.5%
2/44 • Number of events 4 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Blood and lymphatic system disorders
Bruising (in absence of grade 3 or 4 thrombocytopenia)
|
12.5%
5/40 • Number of events 7 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
2.3%
1/44 • Number of events 2 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
15.0%
6/40 • Number of events 8 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
11.4%
5/44 • Number of events 5 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
5/40 • Number of events 7 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
18.2%
8/44 • Number of events 9 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Psychiatric disorders
Depression
|
15.0%
6/40 • Number of events 9 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
9.1%
4/44 • Number of events 6 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
5/40 • Number of events 5 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
11.4%
5/44 • Number of events 6 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Dizziness
|
12.5%
5/40 • Number of events 6 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Gastrointestinal disorders
Drooling
|
17.5%
7/40 • Number of events 7 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
13.6%
6/44 • Number of events 7 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Dysarthria/voice changes
|
17.5%
7/40 • Number of events 7 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
9.1%
4/44 • Number of events 5 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Dysphagia (difficulty swallowing)
|
15.0%
6/40 • Number of events 9 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
20.5%
9/44 • Number of events 9 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Dysphasia/speech impairment
|
10.0%
4/40 • Number of events 5 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
8/40 • Number of events 13 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
13.6%
6/44 • Number of events 10 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Blood and lymphatic system disorders
Edema (limb)
|
15.0%
6/40 • Number of events 12 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
15.9%
7/44 • Number of events 8 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Fall
|
20.0%
8/40 • Number of events 17 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
4.5%
2/44 • Number of events 7 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Fasciculations
|
17.5%
7/40 • Number of events 12 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
9.1%
4/44 • Number of events 7 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
General disorders
Fatigue
|
35.0%
14/40 • Number of events 24 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
20.5%
9/44 • Number of events 13 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
General disorders
Headache
|
17.5%
7/40 • Number of events 7 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
18.2%
8/44 • Number of events 11 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Gastrointestinal disorders
Heartburn
|
10.0%
4/40 • Number of events 5 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
11.4%
5/44 • Number of events 6 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Infections and infestations
Infection (sinus)
|
7.5%
3/40 • Number of events 5 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Infections and infestations
Infection (upper airway)
|
10.0%
4/40 • Number of events 6 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
6.8%
3/44 • Number of events 3 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Insomnia
|
12.5%
5/40 • Number of events 5 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
11.4%
5/44 • Number of events 5 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
17.5%
7/40 • Number of events 8 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
15.9%
7/44 • Number of events 8 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Muscle atrophy (wasting)
|
7.5%
3/40 • Number of events 3 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
4.5%
2/44 • Number of events 7 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Muscle cramps
|
10.0%
4/40 • Number of events 5 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
6.8%
3/44 • Number of events 4 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Muscle weakness (facial)
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
4.5%
2/44 • Number of events 3 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
General disorders
Muscle weakness (generalized)
|
10.0%
4/40 • Number of events 8 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
15.9%
7/44 • Number of events 10 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Muscle weakness (lower extremity)
|
40.0%
16/40 • Number of events 25 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
38.6%
17/44 • Number of events 29 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (trunk)
|
12.5%
5/40 • Number of events 5 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
6.8%
3/44 • Number of events 4 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Muscle weakness (upper extremity)
|
50.0%
20/40 • Number of events 24 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
38.6%
17/44 • Number of events 25 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
10/40 • Number of events 14 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
20.5%
9/44 • Number of events 13 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Musculoskeletal and connective tissue disorders
Pain (back)
|
15.0%
6/40 • Number of events 10 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
General disorders
Pain (chest)
|
10.0%
4/40 • Number of events 5 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Musculoskeletal and connective tissue disorders
Pain (extremity)
|
12.5%
5/40 • Number of events 6 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
11.4%
5/44 • Number of events 6 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.5%
3/40 • Number of events 6 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
0.00%
0/44 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Pyramidal tract dysfunction (increased muscle tone and/or brisk reflexes)
|
20.0%
8/40 • Number of events 9 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
6.8%
3/44 • Number of events 4 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Somnolence
|
5.0%
2/40 • Number of events 2 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
4.5%
2/44 • Number of events 3 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Gastrointestinal disorders
Stomach discomfort
|
5.0%
2/40 • Number of events 5 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
0.00%
0/44 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Nervous system disorders
Tremor
|
15.0%
6/40 • Number of events 7 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
6.8%
3/44 • Number of events 3 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
17.5%
7/40 • Number of events 9 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
6.8%
3/44 • Number of events 5 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
|
General disorders
Weight loss
|
7.5%
3/40 • Number of events 3 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
13.6%
6/44 • Number of events 6 • Adverse events (AEs) were collected for the duration of the study period: January 2009 to October 2009. Each subject was followed for AEs from consent signing to the end of their study participation. The AEs reported here are treatment emergent AEs.
The study was terminated early after the first interim analysis for futility. The first interim analysis was conducted in September 2009. The first subject was randomized in January 2009 and the last follow-up for study subjects was in October 2009.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place