Trial Outcomes & Findings for Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome (NCT NCT00977171)

Last Updated: 2014-06-09

Results Overview

The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Baseline to end of 12 week treatment period

Results posted on

2014-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Droxidopa Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Droxidopa n=3 Participants Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
Age, Continuous	51.8 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to end of 12 week treatment period

Population: 3 patients enrolled in the study prior to it being stopped due to difficulty enrolling patients.

The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.

Outcome measures

Outcome measures
Measure	Droxidopa n=3 Participants Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
Patient Global Impression of Improvement	3 units on a scale Standard Deviation 2.64

Adverse Events

Droxidopa

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Droxidopa n=3 participants at risk Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
Infections and infestations Localised infection	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 6
Investigations Heart rate increased	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 1
Musculoskeletal and connective tissue disorders Fibromyalgia	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Abdominal pain upper	33.3% 1/3 • Number of events 1

Additional Information

Chief Scientific Officer

Chelsea Therapeutics Inc.

Phone: 704-973-4202

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60