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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00747487
Other study ID # SNT-II-003
Secondary ID
Status Completed
Phase Phase 2
First received September 4, 2008
Last updated May 24, 2013
Start date November 2007
Est. completion date February 2010

Study information

Verified date May 2013
Source Santhera Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCanada: Health Canada
Study type Interventional

Clinical Trial Summary

This study is meant to assess the effectiveness of idebenone on visual function measures in patients with Leber's Hereditary Optic Neuropathy over a 6 months period.


Description:

The study involves 6 clinic visits.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 65 Years
Eligibility Inclusion Criteria:

- Age > or = 14 years and < 65 years

- Impaired visual acuity in at least one eye due to LHON

- Onset of visual loss due to LHON lies five years or less prior to Baseline

- Confirmation of either G11778A, T14484C or G3460A LHON mtDNA mutations at >60% in blood

- No explanation for the visual failure besides LHON

- Body weight = 45 kg

- Negative urine pregnancy test at Screening and at Baseline (women of childbearing potential).

Exclusion Criteria:

- Treatment with Coenzyme Q10 or idebenone within 1 month prior to Baseline

- Pregnancy and/or breast-feeding

- Weekly alcohol intake 35 units (men) or 24 units (women)

- Current drug abuse

- Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 2 times the upper limit of normal of AST, ALT or creatinine

- Participation in another clinical trial of any investigational drug within 3 months prior to Baseline

- Other factor that, in the investigator's opinion, excludes the patient from entering the study

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Idebenone
Idebenone 900 mg/day
Placebo
Placebo

Locations

Country Name City State
Canada Unité de recherche clinique Ophtalmologie- Hopital Notre-Dame Montreal Quebec
Germany Klinikum der Universität München - Grosshadern, Neurologische Klinik und Poliklinik Munich
United Kingdom Clinical Research Facility, 4th Floor Leazes Wing, Royal Victoria Infirmary Newcastle Upon Tyne

Sponsors (1)

Lead Sponsor Collaborator
Santhera Pharmaceuticals

Countries where clinical trial is conducted

Canada,  Germany,  United Kingdom, 

References & Publications (2)

Klopstock T, Yu-Wai-Man P, Dimitriadis K, Rouleau J, Heck S, Bailie M, Atawan A, Chattopadhyay S, Schubert M, Garip A, Kernt M, Petraki D, Rummey C, Leinonen M, Metz G, Griffiths PG, Meier T, Chinnery PF. A randomized placebo-controlled trial of idebenone — View Citation

Rudolph G, Dimitriadis K, Büchner B, Heck S, Al-Tamami J, Seidensticker F, Rummey C, Leinonen M, Meier T, Klopstock T. Effects of idebenone on color vision in patients with leber hereditary optic neuropathy. J Neuroophthalmol. 2013 Mar;33(1):30-6. doi: 10 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Best recovery of logMAR visual acuity between baseline and Week 24 in either right or left eye 24 weeks No
Secondary Change in the patient's best logMAR visual acuity between baseline and week 24 24 weeks No
Secondary Change in scotoma area in both eyes Day -1, Week 4, Week 12, Week 24 No
Secondary Change in optic nerve fibre layer thickness in both eyes Day -1, Week 4, Week 12, Week 24 No
Secondary Colour contrast sensitivity in both eyes (in a subset of patients) Day -1, Week 4, Week 12, Week 24 No
Secondary logMAR visual acuity as a continuous variable in both eyes Screening, Day -1, Week 4, Week 12, Week 24, Week 28 No
Secondary Clinical Global Impression of Change Week 4, Week 12 and Week 24 No
Secondary Change in Health-Related Quality of Life (HRQOL) Day -1, Week 4, Week 12, Week 24 No
Secondary Change in self-reported general energy levels Day -1, Week 4, Week 12, Week 24, Week 28 No
Secondary Proportion of patients in which visual acuity in the initially least affected eye does not deteriorate to 1.0 log MAR or more ( in LHON patients with eye still less affected than 0.5 logMAR at trial entry) 24 weeks No
Secondary Plasma levels of idebenone matched to measures of efficacy and safety 24 weeks Yes
Secondary • Best visual acuity at Week 24 (best eye at Week 24) compared to best visual acuity at Baseline (best eye at Baseline) 24 weeks No
Secondary • Count of eyes/ patients for which the visual acuity improves between baseline and week 24 24 weeks No
See also
  Status Clinical Trial Phase
Completed NCT01421381 - RHODOS Follow-up Single-visit Study N/A
Completed NCT04909398 - Pupil Dynamics and Color Vision for the Detection of Eye Diseases N/A
Completed NCT02693119 - A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy Phase 2
Active, not recruiting NCT02161380 - Safety Study of an Adeno-associated Virus Vector for Gene Therapy of Leber's Hereditary Optic Neuropathy Phase 1
Withdrawn NCT01495715 - Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON) Phase 3
No longer available NCT02300753 - Emergency Administration of EPI-743 to a Single Patient With Leber's Hereditary Optic Neuropathy [LHON] N/A
No longer available NCT04381091 - Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study