A Randomized, Double-blind, Placebo-controlled Trial of Curcumin in Leber's Hereditary Optic Neuropathy (LHON)

Optic Atrophy, Hereditary, Leber Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Trial of Curcumin in Leber's Hereditary Optic Neuropathy (LHON)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528151
• Other study ID #: 123/2547
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2007
• Last updated: December 20, 2012
• Start date: May 2005
• Est. completion date: December 2007

Study information

• Verified date: August 2004
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardThailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Leber's hereditary optic neuropathy (LHON) is a maternally inherited disease that is characterized by a simultaneous or more common sequential bilateral loss of central vision, which typically occurs during the teenager years or early adulthood. The disease may be progressive and the patients eventually become blind. In contrast to blindness in patients caused by congenital diseases, the patients who develop blindness caused by LHON will have more trouble in their life because they previously had better vision. Although LHON is associated with mitochondrial DNA mutation at a variable nucleotide position but no certain mechanism of optic nerve injury has been found. It has been postulated that a defect in a complex of respiratory chain enzyme which is caused by mitochondrial DNA dysfunction, results in an increase of free radical substances that interfere with optic nerve function in LHON. Some antioxidant substances have been used to decrease the progression of visual impairment. However, there have been few therapeutic trials for LHON.

Curcumin, a component of tumeric, which comes from the root Curcumin longa has antioxidant, anti-inflammatory and anti-carcinogenic activities. There is some evidence which suggests that curcumin contributes to the in vitro removal of free radical gradients in thalassemic serum and to a clinical improvement of thalassemic patients. We propose a randomized controlled trial study of curcumin, which is an antioxidant substance, for LHON. This study will provide not only an insight into the therapeutic efficacy of curcumin, a kind of Thai herb, for LHON but also the development of future therapeutic strategies to prevent blindness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• LHON patient with 11778 point mutation

Exclusion Criteria:

• LHON patient with other point mutation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Optic Atrophy
• Optic Atrophy, Hereditary, Leber
• Optic Nerve Diseases

Intervention

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

Locations

Country	Name	City	State
Thailand	Professor Wanicha Chuenkongkaew	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual outcome		1 year