Trial Outcomes & Findings for Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury (NCT NCT00041717)

Last Updated: 2020-01-14

Results Overview

The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

213 participants

Primary outcome timeframe

Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98

Results posted on

2020-01-14

Participant Flow

The target population consists of patients with chronic incomplete spinal cord injury (SCI) whose injury occurred at least 18 months prior to screening, and whose neurological status has been stable for at least 6 months.

One patient did not take any investigational drug and was excluded from the safety and ITT populations. The remaining 212 patients were included in the ITT and safety populations: 98 in the placebo and 114 in the Fampridine-SR 25 mg b.i.d. group.

Participant milestones

Participant milestones
Measure	Fampridine-SR 50mg/Day Fampridine-sustained release (SR) : 25mg bid (twice daily)	Placebo Placebo : Placebo
Overall Study STARTED	114	98
Overall Study COMPLETED	81	86
Overall Study NOT COMPLETED	33	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fampridine-SR 50mg/Day n=114 Participants Fampridine-SR : 25mg bid (twice daily)	Placebo n=98 Participants Placebo : Placebo	Total n=212 Participants Total of all reporting groups
Age, Continuous	41.6 years STANDARD_DEVIATION 12.05 • n=5 Participants	40.1 years STANDARD_DEVIATION 13.10 • n=7 Participants	40.9 years STANDARD_DEVIATION 12.54 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	85 Participants n=7 Participants	185 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants	81 Participants n=7 Participants	175 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98

Population: Intent to treat (ITT) population

Outcome measures

Outcome measures
Measure	Fampridine-SR 50mg/Day n=109 Participants Fampridine-SR : 25mg bid (twice daily)	Placebo n=96 Participants Placebo : Placebo
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity	-0.19 units on a scale Standard Error 0.039	-0.15 units on a scale Standard Error 0.042

PRIMARY outcome

Timeframe: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98

Population: ITT

This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome.

Outcome measures

Outcome measures
Measure	Fampridine-SR 50mg/Day n=109 Participants Fampridine-SR : 25mg bid (twice daily)	Placebo n=96 Participants Placebo : Placebo
Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment	-0.2 units on a scale Standard Error 0.08	-0.1 units on a scale Standard Error 0.09

Adverse Events

Fampridine-SR 50mg/Day

Serious events: 6 serious events

Other events: 94 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Andrew Blight, Ph.D. Chief Scientific Officer

Acorda Therapeutics, Inc.

Phone: 914-347-4300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor (Acorda) has right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.
Publication restrictions are in place

Restriction type: OTHER

Measure	Fampridine-SR 50mg/Day n=114 participants at risk Fampridine-SR : 25mg bid (twice daily)	Placebo n=98 participants at risk Placebo : Placebo
Infections and infestations Cellulitis	0.88% 1/114 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	0.00% 0/98 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Infections and infestations Infection	0.00% 0/114 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	1.0% 1/98 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
General disorders Reaction unevaluable	0.00% 0/114 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	1.0% 1/98 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Nervous system disorders Syncope	0.00% 0/114 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	1.0% 1/98 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/114 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	1.0% 1/98 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Infections and infestations Osteomyelitis	0.00% 0/114 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	1.0% 1/98 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Psychiatric disorders Anxiety	0.88% 1/114 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	0.00% 0/98 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Nervous system disorders Aphasia	0.88% 1/114 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	0.00% 0/98 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Psychiatric disorders Hallucinations	0.88% 1/114 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	0.00% 0/98 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Psychiatric disorders Hypertonia	0.00% 0/114 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	1.0% 1/98 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Psychiatric disorders Hyperesthesia	0.88% 1/114 • Number of events 2 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	0.00% 0/98 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Nervous system disorders Hypokinesia	0.88% 1/114 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	0.00% 0/98 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Nervous system disorders Insomnia	0.88% 1/114 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	0.00% 0/98 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Psychiatric disorders Nervousness	0.88% 1/114 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	0.00% 0/98 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Infections and infestations Pneumonia	0.88% 1/114 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	0.00% 0/98 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Infections and infestations Pyelonephritis	0.00% 0/114 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	1.0% 1/98 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Infections and infestations Urinary incontinence	0.88% 1/114 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	0.00% 0/98 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.
Infections and infestations Urinary tract infection	0.00% 0/114 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.	1.0% 1/98 • Number of events 1 • Treatment-emergent serious adverse events (SAE) include SAEs with date of onset (or worsening) on or after the start of double-blind treatment and no more than 30 days after the last dose of investigational drug.