Trial Outcomes & Findings for Ketamine for Treatment of MS Fatigue (NCT NCT03500289)

Results Overview

It is a single item question: 'how much fatigue (tiredness, weariness, problems thinking clearly) have you felt today?' with responses from 0 'None at all' to 10 'Extreme Fatigue'. Reported score changes are the average point/day score change. The mean score is reported based on this calculation: \[(last day measure - baseline measure) / the number of days in the study\].

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Baseline (infusion visit) through day 7

Results posted on

2020-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes	Midazolam Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
Overall Study STARTED	12	6
Overall Study COMPLETED	12	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=12 Participants Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes	Midazolam n=6 Participants Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes	Total n=18 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 12.4 • n=12 Participants	49 years STANDARD_DEVIATION 8.4 • n=6 Participants	45.7 years STANDARD_DEVIATION 11.3 • n=18 Participants
Sex: Female, Male Female	7 Participants n=12 Participants	4 Participants n=6 Participants	11 Participants n=18 Participants
Sex: Female, Male Male	5 Participants n=12 Participants	2 Participants n=6 Participants	7 Participants n=18 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 Participants n=12 Participants	6 Participants n=6 Participants	18 Participants n=18 Participants

PRIMARY outcome

Timeframe: Baseline (infusion visit) through day 7

It is a single item question: 'how much fatigue (tiredness, weariness, problems thinking clearly) have you felt today?' with responses from 0 'None at all' to 10 'Extreme Fatigue'. Reported score changes are the average point/day score change. The mean score is reported based on this calculation: \[(last day measure - baseline measure) / the number of days in the study\].

Outcome measures

Outcome measures
Measure	Ketamine n=12 Participants Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes	Midazolam n=6 Participants Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
Change in Daily Fatigue Severity Score	-0.05 score on a scale Interval -0.19 to 0.08	-0.05 score on a scale Interval -0.14 to 0.24

SECONDARY outcome

Timeframe: Baseline (infusion visit) through day 28 post-infusion

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. Reported score changes are the average point/day score change. The mean score is reported based on this calculation: \[(last day measure - baseline measure) / the number of days in the study\].

Outcome measures

Outcome measures
Measure	Ketamine n=12 Participants Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes	Midazolam n=6 Participants Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
Change in Quality of Life in Neurological Disorders (NeuroQol) Fatigue Item Bank Score	-1.02 score on a scale Interval -1.54 to -0.5	-0.46 score on a scale Interval -1.2 to 0.27

SECONDARY outcome

Timeframe: Baseline (infusion visit) through Day 28 post-infusion

The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue. Reported score changes are the average point/day score change. The mean score is reported based on this calculation: \[(last day measure - baseline measure) / the number of days in the study\].

Outcome measures

Outcome measures
Measure	Ketamine n=12 Participants Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes	Midazolam n=6 Participants Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
Change in Modified Fatigue Impact Scale (MFIS) Score	-0.46 score on a scale Interval -0.7 to -0.23	0.02 score on a scale Interval -0.35 to 0.32

SECONDARY outcome

Timeframe: Baseline (infusion visit) through day 28 post-infusion

The Epworth Sleepiness Scale score can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. Reported score changes are the average point/day score change. The mean score is reported based on this calculation: \[(last day measure - baseline measure) / the number of days in the study\].

Outcome measures

Outcome measures
Measure	Ketamine n=12 Participants Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes	Midazolam n=6 Participants Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
Change in Epworth Sleepiness Scale Score	0.03 score on a scale Interval -0.18 to 0.12	0.11 score on a scale Interval -0.11 to 0.32

SECONDARY outcome

Timeframe: Baseline (infusion visit) through day 28 post-infusion

The total score of the BDI ranges from 0 to 63. Higher scores denote more severe depressive symptoms. Reported score changes are the average point/day score change. The mean score is reported based on this calculation: \[(last day measure - baseline measure) / the number of days in the study\].

Outcome measures

Outcome measures
Measure	Ketamine n=12 Participants Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes	Midazolam n=6 Participants Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
Change in Beck Depression Inventory (BDI) Score	0.07 score on a scale Interval -0.25 to 0.11	0.07 score on a scale Interval -0.33 to 0.18

SECONDARY outcome

Timeframe: Baseline (infusion visit) through day 28 post-infusion

The total score of the FSS ranges from 9 to 63. Higher scores denote more severe fatigue. Reported score changes are the average point/day score change. The mean score is reported based on this calculation: \[(last day measure - baseline measure) / the number of days in the study\].

Outcome measures

Outcome measures
Measure	Ketamine n=12 Participants Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes	Midazolam n=6 Participants Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
Change in Fatigue Severity Scale (FSS) Score	0.03 score on a scale Interval -0.18 to 0.12	0.22 score on a scale Interval -0.11 to 0.32

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Midazolam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine n=12 participants at risk Ketamine: One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes	Midazolam n=6 participants at risk Midazolam: One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
Psychiatric disorders Euphoria	58.3% 7/12 • Number of events 7 • One week	0.00% 0/6 • One week

Additional Information

Dr. Bardia Nourbakhsh

Johns Hopkins University

Phone: 4106141522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place