Trial · NCT03185065

Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis

NCT03185065, Phase 3, Completed, Johns Hopkins University; results first posted 2020-10-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis. Trials, record NCT03185065. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03185065

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Trial

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

Title: Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis
NCT number: NCT03185065
Status: Completed
Phases: Phase 3
Enrollment: 141 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Fatigue in Multiple Sclerosis
Interventions: Amantadine, Modafinil, Methylphenidate, Placebos
First posted: 2017-06-14
Last updated: 2020-10-20
Results first posted: 2020-10-19

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Modified Fatigue Impact Scale (MFIS) Score	Week 5 of each treatment period	MFIS score during the fifth week of treatment period. The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue.
Secondary	Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score	Week 5 of each treatment period	Neuro-QoL Item Bank - Fatigue T score during the fifth week of treatment period. T-score distributions rescale raw scores into standardized scores with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores denote more severe fatigue.
Secondary	Epworth Sleepiness Scale (ESS) Score	Week 5 of each treatment period	ESS score during the fifth week of treatment period. The ESS score can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Modified Fatigue Impact Scale (MFIS) Score	Week 5 of each treatment period	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score	Week 5 of each treatment period	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Epworth Sleepiness Scale (ESS) Score	Week 5 of each treatment period	score on a scale	LEAST_SQUARES_MEAN
POST_HOC	Acceptability of Treatment as Assessed by a Single Question Questionnaire	Week 5 of each treatment period	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Value	Spread	Units
Modified Fatigue Impact Scale (MFIS) Score	Placebo	40.6	95% Confidence Interval 38.2 to 43.1	score on a scale
Modified Fatigue Impact Scale (MFIS) Score	Amantadine	41.3	95% Confidence Interval 38.8 to 43.7	score on a scale
Modified Fatigue Impact Scale (MFIS) Score	Modafinil	39.0	95% Confidence Interval 36.6 to 41.4	score on a scale
Modified Fatigue Impact Scale (MFIS) Score	Methylphenidate	38.6	95% Confidence Interval 36.2 to 41.0	score on a scale
Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score	Placebo	53.1	95% Confidence Interval 51.9 to 54.3	score on a scale
Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score	Amantadine	53.0	95% Confidence Interval 51.7 to 54.2	score on a scale
Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score	Modafinil	52.5	95% Confidence Interval 51.3 to 53.8	score on a scale
Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score	Methylphenidate	52.0	95% Confidence Interval 50.8 to 53.2	score on a scale
Epworth Sleepiness Scale (ESS) Score	Placebo	9.4	95% Confidence Interval 8.7 to 10.1	score on a scale
Epworth Sleepiness Scale (ESS) Score	Amantadine	9.3	95% Confidence Interval 8.6 to 10.1	score on a scale

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow84

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

Period	Milestone	Group	Participants
Period 1 (6 Weeks)	STARTED	Arm A	35
Period 1 (6 Weeks)	STARTED	Arm B	34
Period 1 (6 Weeks)	STARTED	Arm C	35
Period 1 (6 Weeks)	STARTED	Arm D	37
Period 1 (6 Weeks)	COMPLETED	Arm A	32
Period 1 (6 Weeks)	COMPLETED	Arm B	33
Period 1 (6 Weeks)	COMPLETED	Arm C	32
Period 1 (6 Weeks)	COMPLETED	Arm D	36
Period 1 (6 Weeks)	NOT COMPLETED	Arm A	3
Period 1 (6 Weeks)	NOT COMPLETED	Arm B	1

1 to 10 of 84Source ClinicalTrials.gov

See all 84 participant flow

Adverse events80

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	Cardiac disorders	Cardiac disorders	Placebo	3	124
other	Cardiac disorders	Cardiac disorders	Amantadine	3	127
other	Cardiac disorders	Cardiac disorders	Modafinil	2	125
other	Cardiac disorders	Cardiac disorders	Methylphenidate	4	129
other	Ear and labyrinth disorders	Ear and labyrinth disorders	Placebo	0	124
other	Ear and labyrinth disorders	Ear and labyrinth disorders	Amantadine	1	127
other	Ear and labyrinth disorders	Ear and labyrinth disorders	Modafinil	0	125
other	Ear and labyrinth disorders	Ear and labyrinth disorders	Methylphenidate	0	129
other	Eye disorders	Eye disorders	Placebo	0	124
other	Eye disorders	Eye disorders	Amantadine	1	127

1 to 10 of 80Source ClinicalTrials.gov

See all 80 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	124
Total, all-cause mortality	Amantadine	0	127
Total, all-cause mortality	Modafinil	0	125
Total, all-cause mortality	Methylphenidate	0	129
Total, other adverse events	Placebo	38	124
Total, other adverse events	Amantadine	49	127
Total, other adverse events	Modafinil	50	125
Total, other adverse events	Methylphenidate	51	129
Total, serious adverse events	Placebo	0	124
Total, serious adverse events	Amantadine	2	127

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29113955	DERIVED	PubMed
33242419	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 comparisons0

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

None in this release.

Tests0

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

None in this release.

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.

For software

Read this trial from software.

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