NCT00528151

Brief Summary

Background Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited ocular disorder associated with a mutation in mtDNA . The common manifestation is visual loss which caused by the respiratory chain enzymes complex dysfunction resulting in increased oxidative stress enzymes production. Purpose To determine whether curcumin which is an antioxidant agent is beneficial to the patients with 11778 LHON mutation. Material and Method Seventy patients with 11778 LHON mutation were randomly treated with oral curcumin (500 mg/day) and placebo for 1 year. The visual acuity, computerized visual field, electrophysiologic parameters and oxidative stress enzymes in plasma were compared before and after treatment at 3, 6, and 12 months interval.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 24, 2012

Status Verified

August 1, 2004

First QC Date

September 11, 2007

Last Update Submit

December 20, 2012

Conditions

Optic Atrophy, Hereditary, Leber

Keywords

Curcumin, LHON, antioxidant, visual outcome

Outcome Measures

Primary Outcomes (1)

  • visual outcome

    1 year

Study Arms (1)

2

PLACEBO COMPARATOR

1. curcumin 2. placebo

Drug: curcumin

Interventions

curcuminDRUG

curcumin 250 mg twice a day in the first group. placebo 1 capsule twice a day in the second group.

2

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • LHON patient with 11778 point mutation

You may not qualify if:

  • LHON patient with other point mutation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Professor Wanicha Chuenkongkaew

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Optic Atrophy, Hereditary, Leber

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Optic Atrophies, HereditaryOptic AtrophyOptic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesEye Diseases, HereditaryEye DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMitochondrial DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Professor Wanicha L Chuenkongkaew, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

May 1, 2005

Study Completion

December 1, 2007

Last Updated

December 24, 2012

Record last verified: 2004-08

Locations

TH(1)