Trial Outcomes & Findings for Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis (NCT NCT00841321)

Last Updated: 2014-06-06

Results Overview

Performance at exit adjusted for baseline performance on 4 neuropsychological tests: STROOP(Victoria version):Tests attention\&executive function. Outcome is the interference condition condition; time needed to name the colors in which words (which are names of colors) are printed. Words and colors are mismatched. CaliforniaVerbalLearningTest- II: Tests verbal/learning/memory. Outcome number of words (shopping list) remembered after 20 min delay with no cues. PacedAuditorySerialAdditionTest:Tests working memory/sustained attention. Outcome is the number of correct responses to recording giving numbers every 2 sec. Last 2 numbers must be added together before the next number. ControlledOralWordAssociationTest:Tests letter fluency. Outcome number of words produced in one minute for each of 3 letters. Measures reported as Z-scores based on the available population norms for each test; range -infinite +infinite; 0 average; -1=1std below average; +1=1std above average.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

120 participants

Primary outcome timeframe

12 weeks

Results posted on

2014-06-06

Participant Flow

Study sites were the Portland VA Medical Center, Portland, Oregon \& VA Puget Sound Health Care System, Seattle Washington. Enrollment time span was January 2009 to November 2010.

A total of 172 people were assessed for eligibility and 52 did not meet criteria for randomization. Reasons for exclusion included cognitive scores too high (35), Beck Depression Inventory II scores too high (7), failed color vision test(4), usage of contraindicated medications (2); miscellaneous reasons (4).

Participant milestones

Participant milestones
Measure	Placebo Placebo, one capsule orally twice a day for 12 weeks.	Ginkgo Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
Overall Study STARTED	59	61
Overall Study COMPLETED	58	58
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo, one capsule orally twice a day for 12 weeks.	Ginkgo Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
Overall Study Lost to Follow-up	1	1
Overall Study Adverse Event	0	2

Baseline Characteristics

Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=59 Participants Placebo, one capsule orally twice a day for 12 weeks.	Ginkgo n=61 Participants Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants	61 Participants n=7 Participants	120 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	53.0 years STANDARD_DEVIATION 9.5 • n=5 Participants	51.3 years STANDARD_DEVIATION 8.6 • n=7 Participants	52.1 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	29 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	32 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized White	59 participants n=5 Participants	55 participants n=7 Participants	114 participants n=5 Participants
Race/Ethnicity, Customized Non-white	0 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants
Disease duration, average number of years	19.3 years STANDARD_DEVIATION 11.8 • n=5 Participants	20.9 years STANDARD_DEVIATION 11.8 • n=7 Participants	20.1 years STANDARD_DEVIATION 11.8 • n=5 Participants
Expanded Disability Status Scale	4 units on a scale STANDARD_DEVIATION 2 • n=5 Participants	4 units on a scale STANDARD_DEVIATION 2 • n=7 Participants	4 units on a scale STANDARD_DEVIATION 2 • n=5 Participants
Type of Multiple Sclerosis Primary Progressive MS	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Type of Multiple Sclerosis Progressive Remitting MS	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Type of Multiple Sclerosis Relapsing Remitting MS	35 Participants n=5 Participants	42 Participants n=7 Participants	77 Participants n=5 Participants
Type of Multiple Sclerosis Secondary Progressive MS	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Data of all 120 participants was analyzed. For subjects with missing exit values (1 placebo, 2 ginkgo) the baseline measures were carried forward in the analysis.

Outcome measures

Outcome measures
Measure	Ginkgo Baseline n=61 Participants Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.	Ginkgo Exit n=61 Participants Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.	Placebo Baseline n=59 Participants Placebo, one capsule orally twice a day for 12 weeks.	Placebo Exit n=59 Participants Placebo, one capsule orally twice a day for 12 weeks.
Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test. PASAT	-1.4 z-scores Standard Deviation 0.8	-1.3 z-scores Standard Deviation 0.9	-1.2 z-scores Standard Deviation 0.9	-1.0 z-scores Standard Deviation 1.1
Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test. Stroop Interference	-0.9 z-scores Standard Deviation 1.6	-0.8 z-scores Standard Deviation 1.8	01.0 z-scores Standard Deviation 1.4	-0.3 z-scores Standard Deviation 1.1
Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test. COWAT	-0.9 z-scores Standard Deviation 1.0	-0.7 z-scores Standard Deviation 1.0	-1.0 z-scores Standard Deviation 1.0	-0.8 z-scores Standard Deviation 1.0
Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test. CVLT-II delayed free recall	-0.5 z-scores Standard Deviation 1.2	-0.4 z-scores Standard Deviation 1.2	-0.5 z-scores Standard Deviation 1.2	-0.4 z-scores Standard Deviation 1.2

SECONDARY outcome

Timeframe: 12 weeks

The Perceived Deficits Questionnaire (PDQ), a standardized questionnaire in which the subject reports on his or her cognitive function; Measure total score Range (0 best - 80 worse) Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ), in which the family member who was most aware of the participant's cognitive deficits reports on the subject's cognitive deficits; measure total score range (0 best - 60 worse) 'and the Community Integration Questionnaire (CIQ) in which the subject reports his or her degree of social integration; range (0 worst - 32 best); measure total score. Sub-scales for these 3 measures were not used for outcome measures only total scores.

Outcome measures

Outcome measures
Measure	Ginkgo Baseline n=61 Participants Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.	Ginkgo Exit n=61 Participants Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.	Placebo Baseline n=59 Participants Placebo, one capsule orally twice a day for 12 weeks.	Placebo Exit n=59 Participants Placebo, one capsule orally twice a day for 12 weeks.
Secondary Outcome: Measures of Self-report as Well as Family Reports of Subject's Cognitive Deficits and Assessment of Social Integration. PDQ: Perceived deficits Questionnaire	37.2 units on a scale Standard Deviation 11.5	31.7 units on a scale Standard Deviation 11.1	38.2 units on a scale Standard Deviation 13.8	33.4 units on a scale Standard Deviation 15.7
Secondary Outcome: Measures of Self-report as Well as Family Reports of Subject's Cognitive Deficits and Assessment of Social Integration. MSNQ: MS Neuropsychological ScreeningQuestionnaire	25.2 units on a scale Standard Deviation 11.1	24.5 units on a scale Standard Deviation 11.1	27.8 units on a scale Standard Deviation 12.5	27.0 units on a scale Standard Deviation 11.1
Secondary Outcome: Measures of Self-report as Well as Family Reports of Subject's Cognitive Deficits and Assessment of Social Integration. CIQ:Community Integration Questionnaire	23.0 units on a scale Standard Deviation 3.7	23.1 units on a scale Standard Deviation 4.4	23.0 units on a scale Standard Deviation 4.5	22.9 units on a scale Standard Deviation 4.4

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ginkgo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=59 participants at risk Placebo, one capsule orally twice a day for 12 weeks.	Ginkgo n=61 participants at risk Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
Cardiac disorders Myocardial Infarction	0.00% 0/59 • Adverse events were collected at 4 weeks, 8 weeks, 12 weeks and 16 weeks (4 weeks after exit). Subjects reported events. Events were coded according to the Common Terminology Criteria for Adverse Events version 4.	1.6% 1/61 • Number of events 1 • Adverse events were collected at 4 weeks, 8 weeks, 12 weeks and 16 weeks (4 weeks after exit). Subjects reported events. Events were coded according to the Common Terminology Criteria for Adverse Events version 4.
Psychiatric disorders Depression with hospitalization	0.00% 0/59 • Adverse events were collected at 4 weeks, 8 weeks, 12 weeks and 16 weeks (4 weeks after exit). Subjects reported events. Events were coded according to the Common Terminology Criteria for Adverse Events version 4.	1.6% 1/61 • Number of events 1 • Adverse events were collected at 4 weeks, 8 weeks, 12 weeks and 16 weeks (4 weeks after exit). Subjects reported events. Events were coded according to the Common Terminology Criteria for Adverse Events version 4.

Other adverse events

Adverse event data not reported

Additional Information

Dennis Bourdette, MD

Portland VA Medical Center Multiple Sclerosis Center of Excellence

Phone: 503-220-8262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place