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Neuroprotection With Riluzole Patients With Early Multiple Sclerosis

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: NCT00501943
Recruitment Status : Completed
First Posted : July 16, 2007
Results First Posted : April 9, 2014
Last Update Posted : April 9, 2014
Sponsor:
Collaborators:
National Multiple Sclerosis Society
Oregon Health and Science University
Information provided by (Responsible Party):
Emmanuelle Waubant, University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Multiple Sclerosis
Interventions Drug: Avonex (Interferon beta 1a)
Drug: Riluzole
Drug: Placebo
Enrollment 43
Recruitment Details Patients with diagnosis of early Relapsing Remitting MS were invited to participate in the study at 2 US sites- UCSF and OHSU during the period between Dec 2007 and May 2010
Pre-assignment Details  
Arm/Group Title Riluzole Placebo
Hide Arm/Group Description

Riluzole

Riluzole 50 mg BID added to weekly injection of Interferon beta 1a

placebo

1 tab of Placebo BID added to weekly injection of Interferon beta 1a

Period Title: Overall Study
Started 22 21
Completed 20 18
Not Completed 2 3
Arm/Group Title Riluzole Placebo Total
Hide Arm/Group Description

Riluzole

Riluzole 50 mg BID added to weekly injection of Interferon beta 1a

placebo

1 tab of Placebo BID added to weekly injection of Interferon beta 1a

Total of all reporting groups
Overall Number of Baseline Participants 22 21 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 43 participants
38.2  (9.84) 32.4  (7.85) 36  (9.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
Female
17
  77.3%
14
  66.7%
31
  72.1%
Male
5
  22.7%
7
  33.3%
12
  27.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 21 participants 43 participants
22 21 43
1.Primary Outcome
Title MRI Parameter- Percent Brain Volume Change for 2 Years
Hide Description Baseline MRI is compared to MRI images collected during subsequent timepoints. The percent brain volume change is measured using SIENAX (Structural Image Evaluation using Normalization of Atrophy-X)
Time Frame Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24
Hide Outcome Measure Data
Hide Analysis Population Description
Multivariate regression model was used as the statistical method of analysis for the study. So data from patients who have not completed the study are also used for statistical analysis.
Arm/Group Title Riluzole Placebo
Hide Arm/Group Description:

Riluzole

Riluzole 50 mg BID added to weekly injection of Interferon beta 1a

placebo

1 tab of Placebo BID added to weekly injection of Interferon beta 1a

Overall Number of Participants Analyzed 22 21
Mean (95% Confidence Interval)
Unit of Measure: percent change per year
-0.862
(-1.168 to -0.556)
-0.49
(-0.766 to -0.208)
2.Secondary Outcome
Title Changes in Normalized White Matter Volumes (nWMV)
Hide Description The baseline data of white matter volume obtained from the MRI images is compared to data obtained at time points using SIENA (Structural Image Evaluation using Normalization of Atrophy) and SIENAX
Time Frame Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Riluzole Placebo
Hide Arm/Group Description:

Riluzole

Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)

placebo

Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)

Overall Number of Participants Analyzed 22 21
Mean (95% Confidence Interval)
Unit of Measure: percent change per year
-1.75
(-14.709 to 11.213)
-9.69
(-22.206 to 2.825)
3.Secondary Outcome
Title Changes in MS Functional Composite (MSFC)
Hide Description Baseline MSFC data is compared to MSFC data collected during the timepoints. The MSFC is a three-part, standardized, quantitative, assessment instrument that measures the clinical dimensions of leg function, arm/hand function and cognitive function and the components include Timed 25-Foot walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test.
Time Frame Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Riluzole Placebo
Hide Arm/Group Description:

Riluzole

Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)

placebo

Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)

Overall Number of Participants Analyzed 22 21
Mean (95% Confidence Interval)
Unit of Measure: percent change per year
0.041
(-0.043 to 0.126)
0.052
(-0.030 to 0.133)
4.Secondary Outcome
Title Changes in Peripapillary Retinal Nerve Fiber Layer Thickness (RNFL)
Hide Description Baseline RNFL data is compared to the RNFL data collected during the timepoint, and the changes in RNFL is measured using optical coherence tomography (OCT).
Time Frame Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Riluzole Placebo
Hide Arm/Group Description:

Riluzole

Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)

placebo

Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)

Overall Number of Participants Analyzed 22 21
Mean (95% Confidence Interval)
Unit of Measure: percent change per year
-4.670
(-9.309 to -0.032)
-1.839
(-6.692 to 3.014)
5.Secondary Outcome
Title Changes in Symbol Digit Modality Test (SDMT)
Hide Description Baseline SDMT data were compared to SDMT data collected during the timepoints. A simple substitution task, the SDMT gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The total score is the total number of correctly completed boxes in the time allowed. The test score range is from 0(worst outcome) to 110 (best outcome).
Time Frame Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Riluzole Placebo
Hide Arm/Group Description:

Riluzole

Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)

placebo

Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)

Overall Number of Participants Analyzed 22 21
Mean (95% Confidence Interval)
Unit of Measure: percent change per year
0.342
(-0.774 to 1.457)
0.417
(-0.703 to 1.537)
6.Secondary Outcome
Title Changes in Normalized Grey Matter Volume
Hide Description The baseline data of grey matter volume obtained from the MRI images is compared to data obtained at time points using SIENA (Structural Image Evaluation using Normalization of Atrophy) and SIENAX
Time Frame Baseline, Month-3, Month-6, Month-12 and Month-24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Riluzole Placebo
Hide Arm/Group Description:

Riluzole

Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)

placebo

Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)

Overall Number of Participants Analyzed 22 21
Mean (95% Confidence Interval)
Unit of Measure: percent change per year
-14.369
(-30.566 to 1.827)
-18.444
(-34.434 to -2.454)
Time Frame From screening to Month-24 / withdrawal visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Riluzole Placebo
Hide Arm/Group Description

Riluzole

Riluzole 50 mg BID added to weekly injection of Interferon beta 1a

placebo

1 tab of Placebo BID added to weekly injection of Interferon beta 1a

All-Cause Mortality
Riluzole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Riluzole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/21 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Riluzole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/22 (68.18%)      15/21 (71.43%)    
Ear and labyrinth disorders     
dizziness  1  9/22 (40.91%)  9 5/21 (23.81%)  5
Gastrointestinal disorders     
Nausea  1  2/22 (9.09%)  2 7/21 (33.33%)  7
Hepatobiliary disorders     
Elevated liver function tests  1  2/22 (9.09%)  2 1/21 (4.76%)  1
Pregnancy, puerperium and perinatal conditions     
Pregnancy  2/22 (9.09%)  2 1/21 (4.76%)  1
Renal and urinary disorders     
Dysuria  1  0/22 (0.00%)  0 1/21 (4.76%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Emmanuelle Waubant, MD
Organization: UCSF
Phone: 415- 514 2468
EMail: Emmanuelle.Waubant@ucsf.edu
Layout table for additonal information
Responsible Party: Emmanuelle Waubant, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00501943    
Other Study ID Numbers: H9924-29155-05
First Submitted: July 12, 2007
First Posted: July 16, 2007
Results First Submitted: November 19, 2013
Results First Posted: April 9, 2014
Last Update Posted: April 9, 2014