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Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01212094
Recruitment Status : Terminated (The efficacy on CSF biomarkers failed to reach criteria for continuation of the trial)
First Posted : September 30, 2010
Results First Posted : March 28, 2016
Last Update Posted : March 28, 2016
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Drug: Rituximab
Other: normal saline
Enrollment 44
Recruitment Details  
Pre-assignment Details One subject received an open label study drug under a compassionate use amendment of the protocol. This subject is not reflected in the data analysis for the primary or secondary outcome measures.
Arm/Group Title Baseline Placebo Rituximab
Hide Arm/Group Description Patients in their first year baseline prior to study drug phase Group administered placebo Group administered active drug
Period Title: Year 1: Baseline Monitoring
Started 43 0 0
Completed 27 0 0
Not Completed 16 0 0
Reason Not Completed
Study terminated             7             0             0
Withdrawal by Subject             7             0             0
Started on DMT             2             0             0
Period Title: Years 2 & 3: Treatment Randomization
Started 0 9 18
Completed 0 5 7
Not Completed 0 4 11
Reason Not Completed
Study terminated             0             4             7
Withdrawal by Subject             0             0             3
Adverse Event             0             0             1
Arm/Group Title Placebo Rituximab Baseline Total
Hide Arm/Group Description Group administered placebo Group administered active drug Patients in their first year baseline prior to treatment phase Total of all reporting groups
Overall Number of Baseline Participants 9 18 16 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 18 participants 16 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
18
 100.0%
16
 100.0%
43
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 18 participants 16 participants 43 participants
Female
2
  22.2%
9
  50.0%
11
  68.8%
22
  51.2%
Male
7
  77.8%
9
  50.0%
5
  31.3%
21
  48.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 18 participants 16 participants 43 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  33.3%
0
   0.0%
1
   6.3%
4
   9.3%
White
6
  66.7%
18
 100.0%
13
  81.3%
37
  86.0%
More than one race
0
   0.0%
0
   0.0%
1
   6.3%
1
   2.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   6.3%
1
   2.3%
1.Primary Outcome
Title Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration
Hide Description This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares concentration of chemokine CXCL13 before and 3 months after administration of drug into the CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing. CXCL13 is released by activated B cells, T cells and by follicular dendritic cells and has been linked previously with MS inflammation in the brain and spinal cord. The protocol-stipulated threshold for trial continuation was at least 25% decrease in CSF CXCL13 induced by active treatment with significance level p=0.025.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
For the decision to continue trial, only change from baseline to 3 months post-treatment was analyzed in patients who received active drug
Arm/Group Title Placebo Rituximab
Hide Arm/Group Description:
Group administered placebo
Group administered active drug
Overall Number of Participants Analyzed 9 14
Median (Inter-Quartile Range)
Unit of Measure: percentage of b cell depletion
0
(0 to 0)
-11.9
(-100 to 0)
2.Primary Outcome
Title Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration
Hide Description This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares concentration of B-cell activating factor (BAFF) before and 3 months after administration of drug into the CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing. BAFF is consumed by B cells, therefore effective B cell depletion increases levels of BAFF. The protocol-stipulated threshold for trial continuation was at least 50% increase in CSF BAFF induced by active treatment with significance level p=0.025.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
For the decision to continue trial, only change from baseline to 3 months post-treatment was analyzed in patients who received active drug.
Arm/Group Title Placebo Rituximab
Hide Arm/Group Description:
Group administered placebo
Group administered active drug
Overall Number of Participants Analyzed 9 14
Median (Inter-Quartile Range)
Unit of Measure: percentage of BAFF change
4
(-11.2 to 20.5)
20.9
(-0.3 to 24.9)
3.Secondary Outcome
Title Analysis of Changes in CSF B Cell Numbers Between Rituximab and Placebo
Hide Description This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares absolute numbers of CSF B cells calculated as proportion of B cells (identified from flow cytometry data) in all immune cells measured in 50-fold concentrated CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
These patients were analyzed for the interim analysis for the efficacy of B cell depletion. Trial stipulated stopping criteria for futility.
Arm/Group Title Placebo Rituximab
Hide Arm/Group Description:
Group administered placebo
Group administered active drug
Overall Number of Participants Analyzed 9 14
Median (Inter-Quartile Range)
Unit of Measure: percentage of b cell depletion
-21.6
(-70.4 to 25.4)
-50.7
(-83.3 to 49.3)
4.Secondary Outcome
Title Expanded Disability Status Scale (EDSS)
Hide Description Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes was not performed. EDSS is a clinical rating scale for disability ranging from 0 (normal neurological exam) to 10 (death due to MS) in half point increments.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility
Arm/Group Title Placebo Rituximab
Hide Arm/Group Description:
Group administered placebo
Group administered active drug
Overall Number of Participants Analyzed 5 5
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
6.5
(6.5 to 7)
6.5
(6.5 to 6.5)
5.Secondary Outcome
Title Scripps Neurological Rating Scale (NRS)
Hide Description

NRS is a quantitative assessment based on 22 parameters of the neurological exam with scores ranging from maximum of 100 (normal neurological exam) to a minimum of -10 (death due to MS). The higher the score, the better the patient's level of function.

trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense

Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.
Arm/Group Title Placebo Rituximab
Hide Arm/Group Description:
Group administered placebo
Group administered active drug
Overall Number of Participants Analyzed 5 5
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
53
(52 to 55)
53
(53 to 61)
6.Secondary Outcome
Title Timed 25 Foot Walk
Hide Description

Measure of mobility and leg function based on a timed 25 foot walk. Patient is directed to walk as quickly as possible, with or without an assitive device, to one end of a 25foot course and this is repeated for a total of 2 times. The score is the average of the two completed trials.

Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense

Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.
Arm/Group Title Placebo Rituximab
Hide Arm/Group Description:
Group administered placebo
Group administered active drug
Overall Number of Participants Analyzed 5 5
Median (Inter-Quartile Range)
Unit of Measure: seconds
18.7
(11.7 to 32.7)
19.1
(8.7 to 27.2)
7.Secondary Outcome
Title 9-Hole Peg Test
Hide Description

Measure of upper extremity (arm and hand) function where patients are asked to pick up one peg at a time, using one hand only, and putting them into the holes as quickly as possible until all the holes are filled and then removing them one at a time as quickly as possible. The dominant and non-dominant hands are tested twice. The time limit per trial is 5 minutes.

Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense

Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.
Arm/Group Title Placebo Rituximab
Hide Arm/Group Description:
Group administered placebo
Group administered active drug
Overall Number of Participants Analyzed 5 5
Median (Inter-Quartile Range)
Unit of Measure: seconds
25.1
(23.4 to 48.8)
36.7
(36.1 to 45.9)
8.Secondary Outcome
Title Multiple Sclerosis Functional Composite (MSFC)
Hide Description The MSFC is a three-part standardized assessment tool that measures arm, leg, and cognitive function. The scoring is based on the average Z-score for all three parts of the the assessment.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.
Arm/Group Title Placebo Rituximab
Hide Arm/Group Description:
Group administered placebo
Group administered active drug
Overall Number of Participants Analyzed 5 5
Median (Inter-Quartile Range)
Unit of Measure: Z score
-0.7
(-1.2 to 0.2)
-0.9
(-2.3 to -0.7)
9.Secondary Outcome
Title EDSS
Hide Description Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes was not performed. EDSS is a clinical rating scale for disability ranging from 0 (normal neurological exam) to 10 (death due to MS) in half point increments.
Time Frame 0 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Rituximab
Hide Arm/Group Description:
Group administered placebo
Group administered active drug
Overall Number of Participants Analyzed 5 5
Mean (Inter-Quartile Range)
Unit of Measure: units on a scale
6.5
(6.5 to 6.5)
6.5
(6.0 to 6.5)
10.Secondary Outcome
Title Scripps Neurological Rating Scale (NRS)
Hide Description

NRS is a quantitative assessment based on 22 parameters of the neurological exam with scores ranging from maximum of 100 (normal neurological exam) to a minimum of -10 (death due to MS). The higher the score, the better the patient's level of function.

trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense

Time Frame 0 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.
Arm/Group Title Placebo Rituximab
Hide Arm/Group Description:
Group administered placebo
Group administered active drug
Overall Number of Participants Analyzed 5 5
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
57
(54 to 60)
59
(52.3 to 62.5)
11.Secondary Outcome
Title Timed 25 Foot Walk
Hide Description

Measure of mobility and leg function based on a timed 25 foot walk. Patient is directed to walk as quickly as possible, with or without an assitive device, to one end of a 25foot course and this is repeated for a total of 2 times. The score is the average of the two completed trials.

Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense

Time Frame 0 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.
Arm/Group Title Placebo Rituximab
Hide Arm/Group Description:
Group administered placebo
Group administered active drug
Overall Number of Participants Analyzed 5 5
Median (Inter-Quartile Range)
Unit of Measure: seconds
11.9
(8.2 to 29.8)
11.7
(7.6 to 23.6)
12.Secondary Outcome
Title 9-Hole Peg Test
Hide Description

Measure of upper extremity (arm and hand) function where patients are asked to pick up one peg at a time, using one hand only, and putting them into the holes as quickly as possible until all the holes are filled and then removing them one at a time as quickly as possible. The dominant and non-dominant hands are tested twice. The time limit per trial is 5 minutes.

Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense

Time Frame 0 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.
Arm/Group Title Placebo Rituximab
Hide Arm/Group Description:
Group administered placebo
Group administered active drug
Overall Number of Participants Analyzed 5 5
Median (Inter-Quartile Range)
Unit of Measure: seconds
33.7
(25.8 to 44.5)
38.3
(28.8 to 42.4)
13.Secondary Outcome
Title Multiple Sclerosis Functional Composite (MSFC)
Hide Description The MSFC is a three-part standardized assessment tool that measures arm, leg, and cognitive function. The scoring is based on the average Z-score for all three parts of the the assessment.
Time Frame 0 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.
Arm/Group Title Placebo Rituximab
Hide Arm/Group Description:
Group administered placebo
Group administered active drug
Overall Number of Participants Analyzed 5 5
Median (Inter-Quartile Range)
Unit of Measure: Z score
-0.8
(-1.1 to -0.5)
-0.9
(-1.6 to -0.4)
Time Frame 36 months
Adverse Event Reporting Description First 12 months (Month -12 to Month 0), all patients were untreated; next 24 months (Month 0 to Month 24) patients were randomized to placebo or active treatment
 
Arm/Group Title Placebo Rituximab Baseline
Hide Arm/Group Description Placebo group Group who got active drug Patients in their first year baseline prior to study drug phase
All-Cause Mortality
Placebo Rituximab Baseline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Rituximab Baseline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/9 (44.44%)      4/18 (22.22%)      0/43 (0.00%)    
Endocrine disorders       
Elevated Blood Sugar   1/9 (11.11%)  1 0/18 (0.00%)  0 0/43 (0.00%)  0
Hepatobiliary disorders       
Gallstones   1/9 (11.11%)  1 0/18 (0.00%)  0 0/43 (0.00%)  0
Injury, poisoning and procedural complications       
Post LP Headache   1/9 (11.11%)  1 1/18 (5.56%)  1 0/43 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Neck and Back Pain   1/9 (11.11%)  1 0/18 (0.00%)  0 0/43 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Mass   1/9 (11.11%)  1 1/18 (5.56%)  1 0/43 (0.00%)  0
Nervous system disorders       
Cognitive Decline   1/9 (11.11%)  1 0/18 (0.00%)  0 0/43 (0.00%)  0
Paresthesia   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Renal and urinary disorders       
urinary tract infection   0/9 (0.00%)  0 1/18 (5.56%)  2 0/43 (0.00%)  0
Skin and subcutaneous tissue disorders       
Cellulitis   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Rituximab Baseline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/9 (100.00%)      18/18 (100.00%)      8/43 (18.60%)    
Blood and lymphatic system disorders       
anemia   2/9 (22.22%)  2 1/18 (5.56%)  1 0/43 (0.00%)  0
Cardiac disorders       
Tachycardia   2/9 (22.22%)  2 4/18 (22.22%)  4 0/43 (0.00%)  0
Hypertension   1/9 (11.11%)  1 0/18 (0.00%)  0 0/43 (0.00%)  0
Hypotension   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Gastrointestinal disorders       
Nausea/Vomitting   1/9 (11.11%)  1 1/18 (5.56%)  1 0/43 (0.00%)  0
Appendicitis   1/9 (11.11%)  1 0/18 (0.00%)  0 0/43 (0.00%)  0
Abdominal Pain   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Heartburn   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
hernia   0/9 (0.00%)  0 0/18 (0.00%)  0 1/43 (2.33%)  1
General disorders       
Teeth Cracking   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Medication Refill  [1]  0/9 (0.00%)  0 0/18 (0.00%)  0 1/43 (2.33%)  1
Hepatobiliary disorders       
Elevated Liver Enzymes   1/9 (11.11%)  1 0/18 (0.00%)  0 0/43 (0.00%)  0
Immune system disorders       
Leukopenia   1/9 (11.11%)  1 1/18 (5.56%)  1 0/43 (0.00%)  0
Infections and infestations       
fever   0/9 (0.00%)  0 2/18 (11.11%)  2 0/43 (0.00%)  0
Metabolism and nutrition disorders       
hypoalbuminemia   1/9 (11.11%)  1 0/18 (0.00%)  0 0/43 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back Pain   1/9 (11.11%)  1 0/18 (0.00%)  0 0/43 (0.00%)  0
Fall   0/9 (0.00%)  0 2/18 (11.11%)  2 0/43 (0.00%)  0
Shoulder Dislocation   0/9 (0.00%)  0 0/18 (0.00%)  0 1/43 (2.33%)  1
Torn Meniscus   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Dislocated Shoulder   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Sciatica   1/9 (11.11%)  1 0/18 (0.00%)  0 0/43 (0.00%)  0
Nervous system disorders       
Enhancing brain lesion   0/9 (0.00%)  0 0/18 (0.00%)  0 2/43 (4.65%)  2
Paresthesia   0/9 (0.00%)  0 7/18 (38.89%)  8 0/43 (0.00%)  0
headache   0/9 (0.00%)  0 5/18 (27.78%)  7 0/43 (0.00%)  0
Vertigo   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Trigeminal Neuralgia   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Psychiatric disorders       
Depression   1/9 (11.11%)  1 0/18 (0.00%)  0 0/43 (0.00%)  0
Renal and urinary disorders       
UTI   5/9 (55.56%)  8 5/18 (27.78%)  11 0/43 (0.00%)  0
kidney stone   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Reproductive system and breast disorders       
Menorrhagia   1/9 (11.11%)  1 0/18 (0.00%)  0 0/43 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Upper Respiratory Infection   1/9 (11.11%)  1 1/18 (5.56%)  1 0/43 (0.00%)  0
cough   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Skin and subcutaneous tissue disorders       
rash   0/9 (0.00%)  0 4/18 (22.22%)  4 0/43 (0.00%)  0
Lipoma   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Fungal Infection   0/9 (0.00%)  0 0/18 (0.00%)  0 1/43 (2.33%)  2
Contact Dermatitis   0/9 (0.00%)  0 0/18 (0.00%)  0 1/43 (2.33%)  1
laceration   0/9 (0.00%)  0 0/18 (0.00%)  0 1/43 (2.33%)  1
Cellulitis   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Ulcer   1/9 (11.11%)  1 0/18 (0.00%)  0 0/43 (0.00%)  0
Surgical and medical procedures       
bunionectomy   0/9 (0.00%)  0 1/18 (5.56%)  1 0/43 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
event was classified as an SAE by the IRB however no hospitalization was needed and the event did not result in other serious outcomes.
The trial was closed prematurely for futility, because pre-determined interim analysis demonstrated that selected dosing led to <50% depletion of B cells from the brain/spinal cord. Therefore, only 5 patients per group finished trial.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bibiana Bielekova, Prinicipal Investigator
Organization: NINDS, NIH
Phone: 301-402-4488
EMail: bibiana.bielekova@nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT01212094    
Other Study ID Numbers: 100212
10-N-0212
First Submitted: September 29, 2010
First Posted: September 30, 2010
Results First Submitted: March 9, 2016
Results First Posted: March 28, 2016
Last Update Posted: March 28, 2016