NCT00841321

Brief Summary

The purpose of this study is to see if treatment with Ginkgo improves cognitive function in people with multiple sclerosis who have cognitive problems.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2 multiple-sclerosis

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

May 5, 2014

Completed
Last Updated

June 6, 2014

Status Verified

May 1, 2014

Enrollment Period

1.8 years

First QC Date

February 9, 2009

Results QC Date

October 22, 2013

Last Update Submit

May 23, 2014

Conditions

Multiple SclerosisCognitive Ability, General

Keywords

Ginkgo bilobaMultiple SclerosisCognitionNeuropsychological TestsNeurobehavioral ManifestationsQuality of lifeRandomized Controlled TrialsPlacebosDouble-Blind Method

Outcome Measures

Primary Outcomes (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.

    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.

    12 weeks

Secondary Outcomes (1)

  • Secondary Outcome: Measures of Self-report as Well as Family Reports of Subject's Cognitive Deficits and Assessment of Social Integration.

    12 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Subjects with multiple sclerosis and documented cognitive impairment will be randomized to take the intervention or placebo.

Drug: Ginkgo biloba

Arm 2

PLACEBO COMPARATOR

Subjects with multiple sclerosis and documented cognitive impairment will be randomized to receive the placebo.

Drug: Placebo

Interventions

Ginkgo bilobaDRUG

120 mg orally twice a day for 12 weeks

Also known as: EGb 761
Arm 1
PlaceboDRUG

One capsule orally twice a day for 12 weeks

Arm 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of multiple sclerosis by McDonald's criteria
  • Age 18 to 65 years, inclusive
  • A score minus one standard deviation below the mean on one or more of the following tests: PASAT, COWAT, CVLT-II, Stroop
  • EDSS 0 - 7.5, inclusive
  • No Ginkgo biloba in preceding 30 days
  • Native English speaker

You may not qualify if:

  • Current substance abuse disorder, psychosis, or significant depression (score on the Beck Depression Inventory II (BDI -II) greater than 28
  • Any significant uncontrolled medical problem including diabetes requiring insulin
  • Relapse of multiple sclerosis within the 30 days before screening
  • Abnormalities of coagulation or current use of anticoagulants or antiplatelet agents
  • Elective surgery planned for the study period or the following four weeks
  • Epilepsy or history of seizures
  • Use of nifedipine, nicardipine, Saint John's Wort, papaverine, mono amine oxidase inhibitors
  • Pregnancy or women not using a reliable form of contraception
  • Corrected binocular visual acuity worse than 20/50 or more than one error on binocular color vision testing with the Ishihara Color Plates or sustained nystagmus or diplopia on primary gaze
  • Inability to complete the neuropsychological test battery at the screening visit
  • History of alcohol abuse or illicit drug use in the prior six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Portland VA Medical Center, Portland, OR

Portland, Oregon, 97239, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (2)

  • Lovera JF, Kim E, Heriza E, Fitzpatrick M, Hunziker J, Turner AP, Adams J, Stover T, Sangeorzan A, Sloan A, Howieson D, Wild K, Haselkorn J, Bourdette D. Ginkgo biloba does not improve cognitive function in MS: a randomized placebo-controlled trial. Neurology. 2012 Sep 18;79(12):1278-84. doi: 10.1212/WNL.0b013e31826aac60. Epub 2012 Sep 5.

    PMID: 22955125RESULT

  • Hughes AJ, Parmenter BA, Haselkorn JK, Lovera JF, Bourdette D, Boudreau E, Cameron MH, Turner AP. Sleep and its associations with perceived and objective cognitive impairment in individuals with multiple sclerosis. J Sleep Res. 2017 Aug;26(4):428-435. doi: 10.1111/jsr.12490. Epub 2017 Jan 17.

    PMID: 28093823DERIVED

Related Links

MeSH Terms

Conditions

Multiple SclerosisNeurobehavioral Manifestations

Interventions

Ginkgo ExtractGinkgo biloba extract

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Limitations and Caveats

Limitations include underrepresentation of minorities. Subjects overall had mild impairment.

Results Point of Contact

Title
Dennis Bourdette, MD
Organization
Portland VA Medical Center Multiple Sclerosis Center of Excellence
dennis.bourdette@va.gov
503-220-8262

Study Officials

  • Dennis N. Bourdette, MD

    Portland VA Medical Center, Portland, OR

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 11, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

June 6, 2014

Results First Posted

May 5, 2014

Record last verified: 2014-05

Locations

US(2)