Trial · NCT02280096

Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis

NCT02280096, Phase 2, Completed, Coordinación de Investigación en Salud, Mexico; results first posted 2019-09-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis. Trials, record NCT02280096. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02280096

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis
NCT number: NCT02280096
Status: Completed
Phases: Phase 2
Enrollment: 24 participants, actual
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Conditions: Multiple Sclerosis
Interventions: 4-aminopyridine, Placebo
First posted: 2014-10-31
Last updated: 2019-09-12
Results first posted: 2019-09-12
Limitations and caveats: As the sample size is very small, it is recommended to increase the number of patients. The heterogeneity in cognitive processes would imply a greater restriction criteria in the selection of patients to avoid the ceiling effect.

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Brief Repeatable Battery of Rao	10-15 minutes	Neuropsychological tests to assess: verbal fluency. Participants have to say as many words as possible from a category in a given time 60 Sec (F, A, S) Max score 72 and min score 19 words. Higher scores indicate a better cognitive performance.
Primary	Integrated Program of Neuropsychological Exploration Test Barcelona	7-10 min	Integrated Program of Neuropsychological Exploration Test Barcelona: Digit Span Forward (DSF), (attention spam and improved scoring metrics significantly enhance the precision of DSF assessments of short-term verbal memory). Digit sequences are presented beginning with a length of two digits and two trials are presented at each increasing list length. Max score 8 and min score 0 digits. Higher scores indicate a better cognitive performance.
Primary	Rey-Osterrieth Complex Figure Test (ROCF)	10-15 minutes	The purpose of this test is to assess visual-spatial constructional ability and visual memory. The time required to copy the drawing is recorded. Less time indicates a better performance and more time indicates a worse outcome (min score 60 and max score 300 seconds).
Primary	Five Digit Test (FDT). Processing Speed	8-10 min	Processing speed information (which includes reading, count, and alternation speed). Cards with a different number of stimuli are shown to the patient, who has to read, count, and respond to a change of instructions (alternation). Reading speed (min 12, max 31+ seconds), counting speed (min 14, max 28+ seconds), and alternation speed (min 26, max 56+ seconds) are recorded. Less speed corresponds to a better outcome.
Primary	Wisconsin Card Sorting Test (WCST)	10-15 minutes	Is used primarily to assess perseveration and abstract thinking, allows the clinician to assess the following 'frontal' lobe functions: strategic planning, organised searching, utilising environmental feedback to shift cognitive sets, directing behaviour toward achieving a goal. WCST measures abstract reasoning and ability to alter problem solving strategies. Patients are given 128 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only "right" or "wrong" to each placement. The examiner may change matching rules during the test. Perseveration errors occur when subject repeats the same error no matter how many times they are told the placement is wrong. Higher scores indicate a worse cognitive performance (min=0-3, max=58-126)
Primary	Color Trails Test (CTT)	5-8 minutes	Measure sustained attention. The CTT uses numbered coloured circles and universal sign language symbols. The circles are printed with vivid pink or yellow backgrounds that are perceptible to colourblind individuals. For the Colour Trails 1 trial, the respondent uses a pencil to rapidly connect circles numbered 1 through 25 in sequence. Less time indicates better performance (min=10, max= 240).
Primary	Tower Of London (TOL). Total Moves and Total Correct Moves	25-30 minutes	Measures higher order problem-solving ability. The information it provides is not only useful when assessing frontal lobe damage, but also when evaluating attention disorders and executive functioning difficulties. The administrator arranges red, green, and blue beads on a peg board to match the configuration in the diagram. The patient is asked to replicate the configuration on a second peg board. Scores are calculated for Total Correct Moves and Total Moves. Total moves: higher scores indicate a worse cognitive performance (min= 0, max=58+); Total correct higher scores indicate a better cognitive performance (min=0, max=10).
Primary	Tower Of London (TOL). Execution Time and Problem-solving Time	25-30 minutes	Measures higher-order problem-solving ability. The information it provides is not only useful when assessing frontal lobe damage, but also when evaluating attention disorders and executive functioning difficulties. The administrator arranges red, green, and blue beads on a peg board to match the configuration in the diagram. The patient is asked to replicate the configuration on a second peg board. Scores are calculated for Total Execution Time (since the patient performs the first move until he ends the test), Total Problem-Solving Time (the sum of planning and execution times). Total execution time higher scores indicate a worse outcome (min= 0-78, max=564+ seconds), Total problem-solving time higher scores indicate a worse outcome (min= 0-56, max=500+ seconds).
Secondary	Improved Physical Capacity	15-20 minutes	The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. The first levels 1.0 to 4.5 refers to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refers to the loss of ambulatory ability. It also provides eight subscale measurements called Functional System (FS) scores. The levels of function within each category refer to the eight FS affected by MS: The FS are scored on a scale of 0 (low level of problems) to 5 (high level of problems) to best reflect the level of disability observed clinically.
Secondary	Fatigue	10 minutes	The Fatigue Severity Scale (FSS) is one of the most frequently used inventories for measuring fatigue in people with chronic illnesses. The FSS questionnaire is comprised of nine statements inquiring about the examinee's sleep habits over the preceding week. Ratings are on a 7-point Likert scale, where higher scores indicate how strongly the patient agrees with the nine statements.Scale. Scoring using a bimodal response system or a Likert score with weights assigned to each response choice. Likert or bimodal rating scales with 4 response options. For the Likert Scale: better than usual= 0, no more than usual= 1, worse than usual= 2, much worse than usual= 3. For the bimodal scale: better than usual= 0, no more than usual= 0, worse than usual= 1, much worse than usual= 1. Sum all items for a total score. Score range. Range is 0 -11 for bimodal response format. Interpretation of scores. Higher score indicates more fatigue. Self report scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Brief Repeatable Battery of Rao	10-15 minutes	Word List Generation (3 trials/60 sec)	Correct words	MEAN
PRIMARY	Integrated Program of Neuropsychological Exploration Test Barcelona	7-10 min	Attention spam.	correct numbers recalled	MEAN
PRIMARY	Rey-Osterrieth Complex Figure Test (ROCF)	10-15 minutes		units on a scale (seconds)	MEAN
PRIMARY	Five Digit Test (FDT). Processing Speed	8-10 min		seconds	MEAN
PRIMARY	Wisconsin Card Sorting Test (WCST)	10-15 minutes		score on a scale	MEAN
PRIMARY	Color Trails Test (CTT)	5-8 minutes	Color Trails Test 1. Execution time	units on a scale (seconds)	MEAN
PRIMARY	Tower Of London (TOL). Total Moves and Total Correct Moves	25-30 minutes		score on a scale	MEAN
PRIMARY	Tower Of London (TOL). Execution Time and Problem-solving Time	25-30 minutes		seconds	MEAN
SECONDARY	Improved Physical Capacity	15-20 minutes		score on a scale	MEAN
SECONDARY	Fatigue	10 minutes		score on a scale	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Brief Repeatable Battery of Rao	4-aminopyridine		42.09	Standard Deviation 14.5	Correct words
The Brief Repeatable Battery of Rao	Placebo		35.5	Standard Deviation 6.6	Correct words
Integrated Program of Neuropsychological Exploration Test Barcelona	4-aminopyridine		6.1	Standard Deviation 1.5	correct numbers recalled
Integrated Program of Neuropsychological Exploration Test Barcelona	Placebo		5	Standard Deviation 0.8	correct numbers recalled
Rey-Osterrieth Complex Figure Test (ROCF)	4-aminopyridine		208.6	Standard Deviation 121.2	units on a scale (seconds)
Rey-Osterrieth Complex Figure Test (ROCF)	Placebo		231.2	Standard Deviation 114.8	units on a scale (seconds)
Five Digit Test (FDT). Processing Speed	4-aminopirydine	Reading speed	28	Standard Deviation 9	seconds
Five Digit Test (FDT). Processing Speed	Placebo	Reading speed	29.6	Standard Deviation 4.2	seconds
Five Digit Test (FDT). Processing Speed	4-aminopirydine	Count speed	30.5	Standard Deviation 9.2	seconds
Five Digit Test (FDT). Processing Speed	Placebo	Count speed	34.2	Standard Deviation 12	seconds

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	4-aminopyridine Treatment	13
Overall Study	STARTED	Placebo	11
Overall Study	COMPLETED	4-aminopyridine Treatment	11
Overall Study	COMPLETED	Placebo	10
Overall Study	NOT COMPLETED	4-aminopyridine Treatment	2
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Insominia	Psychiatric disorders	4-aminopyridine	7	11
other	Insominia	Psychiatric disorders	Placebo	8	10
other	Headache	Nervous system disorders	4-aminopyridine	6	11
other	Headache	Nervous system disorders	Placebo	7	10
other	Nausea	Gastrointestinal disorders	4-aminopyridine	6	11
other	Nausea	Gastrointestinal disorders	Placebo	3	10
other	Vertigo	Nervous system disorders	4-aminopyridine	6	11
other	Vertigo	Nervous system disorders	Placebo	3	10
other	Tremor in hands	Nervous system disorders	4-aminopyridine	4	11
other	Tremor in hands	Nervous system disorders	Placebo	1	10

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	4-aminopyridine	0	11
Total, all-cause mortality	Placebo	0	10
Total, other adverse events	4-aminopyridine	7	11
Total, other adverse events	Placebo	8	10
Total, serious adverse events	4-aminopyridine	0	11
Total, serious adverse events	Placebo	0	10

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
7936300	BACKGROUND	PubMed
11795455	BACKGROUND	PubMed
15327047	BACKGROUND	PubMed
16643949	BACKGROUND	PubMed
24290498	BACKGROUND	PubMed
30593980	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
4-aminopyridine vs Placebo: deaths from any cause	Trial comparisons
4-aminopyridine vs Placebo: serious adverse events	Trial comparisons

Tests5

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Card Sorting Test (Berg)	Primary outcome	ConductCognition
Complex Figure Copy and Recall	Primary outcome	ConductCognition
Digit Span Test	Primary outcome	ConductCognition
Tower Planning	Primary outcome	ConductCognition
Verbal Fluency	Primary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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