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Trial Outcomes & Findings for Neuroprotection With Riluzole Patients With Early Multiple Sclerosis (NCT NCT00501943)

NCT ID: NCT00501943

Last Updated: 2014-04-09

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24

Results posted on

2014-04-09

Participant Flow

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

Participant milestones

Participant milestones
Measure
Riluzole
Riluzole Riluzole 50 mg BID added to weekly injection of Interferon beta 1a
Placebo
placebo 1 tab of Placebo BID added to weekly injection of Interferon beta 1a
Overall Study
STARTED
22
21
Overall Study
COMPLETED
20
18
Overall Study
NOT COMPLETED
2
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neuroprotection With Riluzole Patients With Early Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Riluzole
n=22 Participants
Riluzole Riluzole 50 mg BID added to weekly injection of Interferon beta 1a
Placebo
n=21 Participants
placebo 1 tab of Placebo BID added to weekly injection of Interferon beta 1a
Total
n=43 Participants
Total of all reporting groups
Age, Continuous
38.2 years
STANDARD_DEVIATION 9.84 • n=5 Participants
32.4 years
STANDARD_DEVIATION 7.85 • n=7 Participants
36 years
STANDARD_DEVIATION 9.32 • n=5 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
14 Participants
n=7 Participants
31 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
7 Participants
n=7 Participants
12 Participants
n=5 Participants
Region of Enrollment
United States
22 participants
n=5 Participants
21 participants
n=7 Participants
43 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24

Population: 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.

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)

Outcome measures

Outcome measures
Measure
Riluzole
n=22 Participants
Riluzole Riluzole 50 mg BID added to weekly injection of Interferon beta 1a
Placebo
n=21 Participants
placebo 1 tab of Placebo BID added to weekly injection of Interferon beta 1a
MRI Parameter- Percent Brain Volume Change for 2 Years
-0.862 percent change per year
Interval -1.168 to -0.556
-0.49 percent change per year
Interval -0.766 to -0.208

SECONDARY outcome

Timeframe: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24

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

Outcome measures

Outcome measures
Measure
Riluzole
n=22 Participants
Riluzole Riluzole 50 mg BID added to weekly injection of Interferon beta 1a
Placebo
n=21 Participants
placebo 1 tab of Placebo BID added to weekly injection of Interferon beta 1a
Changes in Normalized White Matter Volumes (nWMV)
-1.75 percent change per year
Interval -14.709 to 11.213
-9.69 percent change per year
Interval -22.206 to 2.825

SECONDARY outcome

Timeframe: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24

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.

Outcome measures

Outcome measures
Measure
Riluzole
n=22 Participants
Riluzole Riluzole 50 mg BID added to weekly injection of Interferon beta 1a
Placebo
n=21 Participants
placebo 1 tab of Placebo BID added to weekly injection of Interferon beta 1a
Changes in MS Functional Composite (MSFC)
0.041 percent change per year
Interval -0.043 to 0.126
0.052 percent change per year
Interval -0.03 to 0.133

SECONDARY outcome

Timeframe: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24

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).

Outcome measures

Outcome measures
Measure
Riluzole
n=22 Participants
Riluzole Riluzole 50 mg BID added to weekly injection of Interferon beta 1a
Placebo
n=21 Participants
placebo 1 tab of Placebo BID added to weekly injection of Interferon beta 1a
Changes in Peripapillary Retinal Nerve Fiber Layer Thickness (RNFL)
-4.670 percent change per year
Interval -9.309 to -0.032
-1.839 percent change per year
Interval -6.692 to 3.014

SECONDARY outcome

Timeframe: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24

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).

Outcome measures

Outcome measures
Measure
Riluzole
n=22 Participants
Riluzole Riluzole 50 mg BID added to weekly injection of Interferon beta 1a
Placebo
n=21 Participants
placebo 1 tab of Placebo BID added to weekly injection of Interferon beta 1a
Changes in Symbol Digit Modality Test (SDMT)
0.342 percent change per year
Interval -0.774 to 1.457
0.417 percent change per year
Interval -0.703 to 1.537

SECONDARY outcome

Timeframe: Baseline, Month-3, Month-6, Month-12 and Month-24

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

Outcome measures

Outcome measures
Measure
Riluzole
n=22 Participants
Riluzole Riluzole 50 mg BID added to weekly injection of Interferon beta 1a
Placebo
n=21 Participants
placebo 1 tab of Placebo BID added to weekly injection of Interferon beta 1a
Changes in Normalized Grey Matter Volume
-14.369 percent change per year
Interval -30.566 to 1.827
-18.444 percent change per year
Interval -34.434 to -2.454

Adverse Events

Riluzole

Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Riluzole
n=22 participants at risk
Riluzole Riluzole 50 mg BID added to weekly injection of Interferon beta 1a
Placebo
n=21 participants at risk
placebo 1 tab of Placebo BID added to weekly injection of Interferon beta 1a
Pregnancy, puerperium and perinatal conditions
Pregnancy
9.1%
2/22 • Number of events 2 • From screening to Month-24 / withdrawal visit.
4.8%
1/21 • Number of events 1 • From screening to Month-24 / withdrawal visit.
Gastrointestinal disorders
Nausea
9.1%
2/22 • Number of events 2 • From screening to Month-24 / withdrawal visit.
33.3%
7/21 • Number of events 7 • From screening to Month-24 / withdrawal visit.
Ear and labyrinth disorders
dizziness
40.9%
9/22 • Number of events 9 • From screening to Month-24 / withdrawal visit.
23.8%
5/21 • Number of events 5 • From screening to Month-24 / withdrawal visit.
Hepatobiliary disorders
Elevated liver function tests
9.1%
2/22 • Number of events 2 • From screening to Month-24 / withdrawal visit.
4.8%
1/21 • Number of events 1 • From screening to Month-24 / withdrawal visit.
Renal and urinary disorders
Dysuria
0.00%
0/22 • From screening to Month-24 / withdrawal visit.
4.8%
1/21 • Number of events 1 • From screening to Month-24 / withdrawal visit.

Additional Information

Dr Emmanuelle Waubant, MD

UCSF

Phone: 415- 514 2468

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place