Trial Outcomes & Findings for Memantine for Spasticity in MS Patients (NCT NCT00638027)

Results Overview

spasticity scale score: the most common used tool to measure the degree of spasticity of the lower extremities. Score: Degree of Muscle Tone 0: no increase in tone 1. slight increase in tone 1+: slight increase in tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion. 2. more marked increase in muscle tone through most of the range of movement, but affected part(s) easily moved. 3. considerable increase in muscle tone, passive movement difficult. 4. affected part(s) rigid in flexion or extension.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2015-12-07

Participant Flow

Recruitment for the trial began in June 2006 and ended in June 2008. The last subject formally completed the trial in September 2008

Participant milestones

Participant milestones
Measure	Memantine Memantine 10 mg bid	Placebo Placebo arm
Overall Study STARTED	11	10
Overall Study COMPLETED	11	8
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Memantine Memantine 10 mg bid	Placebo Placebo arm
Overall Study Adverse Event	0	2

Baseline Characteristics

Memantine for Spasticity in MS Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Memantine n=11 Participants Memantine 10 mg bid	Placebo n=10 Participants Placebo arm	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Age, Continuous	52.9 years STANDARD_DEVIATION 7.5 • n=5 Participants	52.1 years STANDARD_DEVIATION 12.2 • n=7 Participants	52.5 years STANDARD_DEVIATION 9.8 • n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Per Protocol

spasticity scale score: the most common used tool to measure the degree of spasticity of the lower extremities. Score: Degree of Muscle Tone 0: no increase in tone 1. slight increase in tone 1+: slight increase in tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion. 2. more marked increase in muscle tone through most of the range of movement, but affected part(s) easily moved. 3. considerable increase in muscle tone, passive movement difficult. 4. affected part(s) rigid in flexion or extension.

Outcome measures

Outcome measures
Measure	Memantine n=11 Participants Memantine 10 mg bid	Placebo n=10 Participants Placebo arm
Difference in Ashworth Spasticity Scale Score Between Baseline and 12 Weeks	-1.55 units on a scale Standard Deviation 2.81	-1.00 units on a scale Standard Deviation 2.67

SECONDARY outcome

Timeframe: baseline, 12 weeks

Population: per protocol

Multiple Sclerosis Spacticy Scale (MSSS-88) is a patient reported questionnaire rating scale to quantify the perspectives of the impact of spasticity on people with multiple sclerosis. Scoring: Individual items are scored on a 4 point Likert scale: 1 (Not bothered at all), 2 (a little bothered), 3 (moderately bothered), 4 (extremely bothered).This questionnaire asks how bothered you have been by your spasticity in the past two weeks. By spasticity we mean muscle stiffness and spasms.The MSSS-88 is a reliable and valid, patient-based, interval-level measure of the impact of spasticity in multiple sclerosis. Scores were summed, without weighting or standardization, to generate ordinal-level total scores just as any other Likert-type scale. Missing responses to items can be replaced with the mean score of the items completed (person-specific item mean score) provided that 50% or more of the items in a scale have been completed. The range is 8-32 and higher scores mean poorer outcome.

Outcome measures

Outcome measures
Measure	Memantine n=11 Participants Memantine 10 mg bid	Placebo n=10 Participants Placebo arm
Difference in the Multiple Sclerosis Spacticy Scale (MSSS-88) Between Baseline and 12 Weeks	-5.55 units on a scale Standard Deviation 7.89	-3.33 units on a scale Standard Deviation 7.07

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Per protocol

9-Hole Peg Test (9-HPT) is a quantitative measure of upper extremity function. Timed 25-Foot Walk (T 25 FW) is a quantitative measure of lower extremity function. The patient is instructed to walk 25 feet as quickly as possible, but safely. Paced Auditory Serial Addition Test-3 seconds (PASAT-3) is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The MSFC is based on the concept that scores for these 3 dimensions-arm, leg, and cognitive function are combined to create a single score that can be used to detect change over time in a group of MS patients. This is done by creating Z-scores for each component of the MSFC. Implicit in this approach is the idea that patients who deteriorate or improve on all 3 component measures will have an overall larger change than patients who change on only 1 of the 3 measures. The MSFC score was transformed to z-scores, with higher scores indicating better outcome.

Outcome measures

Outcome measures
Measure	Memantine n=11 Participants Memantine 10 mg bid	Placebo n=10 Participants Placebo arm
Change in Multiple Sclerosis Functional Composite (MSFC) Score Between Baseline and Week 12	0.02 Z score Standard Deviation 0.26	-0.04 Z score Standard Deviation 0.2

Adverse Events

Memantine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Memantine n=11 participants at risk Memantine 10 mg bid	Placebo n=10 participants at risk Placebo arm
Musculoskeletal and connective tissue disorders neck pain	0.00% 0/11 • 12 weeks	10.0% 1/10 • Number of events 1 • 12 weeks
Renal and urinary disorders urinary tract infection	0.00% 0/11 • 12 weeks	10.0% 1/10 • Number of events 1 • 12 weeks
Musculoskeletal and connective tissue disorders left ankle sprain	0.00% 0/11 • 12 weeks	10.0% 1/10 • Number of events 1 • 12 weeks
General disorders nausea	0.00% 0/11 • 12 weeks	10.0% 1/10 • Number of events 1 • 12 weeks
Infections and infestations influenza	0.00% 0/11 • 12 weeks	10.0% 1/10 • Number of events 1 • 12 weeks

Additional Information

Cynthia Irish, RN, MSCN

University of Rochester

Phone: 585-275-6120

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place