A study to verify the statusof the patients who participated to the RHODOS trial in the past

A single visit, observational, follow-up study of Patients with Leber’s Hereditary Optic Neuropathy following participation in SNT-II-003 trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001034-42-DE

Enrollment

Registered

2011-03-22

Start date

2011-08-25

Completion date

Unknown

Last updated

2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leber’s Hereditary Optic Neuropathy MedDRA version: 13.1 Level: LLT Classification code 10062951 Term: Leber's hereditary optic atrophy neuropathy System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Product Name: Idebenone Product Code: SNT-MC17 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Idebenone CAS Number: 58186279 Current Sponsor code: SNT-MC17 Concentration unit: mg milligr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: LHON patients who participated in study SNT-II-003 Are the trial subjects under 18? yes Number of subjects for this age range: 3 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 41 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: There will be no exclusion criteria.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the current logMAR visual acuity of LHON patients who participated in the SNT-II-003 trial with their logMAR visual acuity at Visit 5/last treatment visit of SNT-II-003 ;Secondary Objective: To compare the current Health Related Quality of Life (HRQoL) status of patients who participated in the SNT-II-003 trial with the result from Visit 5/last treatment visit of SNT-II-003 To compare the current logMAR visual acuity score and Health Related Quality of Life (HRQoL) status with the corresponding Baseline/Visit 2 data in SNT-II-003 To investigate whether any medical procedure or medication undertaken or received since the patient’s last visit of SNT-II-003 may have affected the natural history of LHON ;Primary end point(s): Change in best logMAR visual acuity (Best Acuity) compared to Visit 5/last treatment visit of SNT-II-003;Timepoint(s) of evaluation of this end point: Single visit study	—

Measure

Time frame

Main Objective: To compare the current logMAR visual acuity of LHON patients who participated in the SNT-II-003 trial with their logMAR visual acuity at Visit 5/last treatment visit of SNT-II-003 ;Secondary Objective: To compare the current Health Related Quality of Life (HRQoL) status of patients who participated in the SNT-II-003 trial with the result from Visit 5/last treatment visit of SNT-II-003 To compare the current logMAR visual acuity score and Health Related Quality of Life (HRQoL) status with the corresponding Baseline/Visit 2 data in SNT-II-003 To investigate whether any medical procedure or medication undertaken or received since the patient’s last visit of SNT-II-003 may have affected the natural history of LHON ;Primary end point(s): Change in best logMAR visual acuity (Best Acuity) compared to Visit 5/last treatment visit of SNT-II-003;Timepoint(s) of evaluation of this end point: Single visit study

—

Secondary

Measure	Time frame
Secondary end point(s): •Change in best logMAR visual acuity (Best Acuity) compared to Visit 2/Baseline visit of SNT-II-003 •Change in logMAR visual acuity of individual eyes compared to Visit 5/last treatment visit of SNT-II-003 •Change in logMAR visual acuity of individual eyes compared to Visit 2/Baseline visit of SNT-II-003 •Change in logMAR visual acuity of a patient’s best eye compared to the same eye at Visit 5/last treatment visit of SNT-II-003 •Change in Health-Related Quality of Life (HRQoL) assessed by VF-14 questionnaire compared to Visit 5/last treatment visit of SNT-II-003 •Change in Health-Related Quality of Life (HRQoL) assessed by VF-14 questionnaire compared to Visit 2/Baseline visit of SNT-II-003 ;Timepoint(s) of evaluation of this end point: Single visit study	—

Measure

Time frame

Secondary end point(s): •Change in best logMAR visual acuity (Best Acuity) compared to Visit 2/Baseline visit of SNT-II-003 •Change in logMAR visual acuity of individual eyes compared to Visit 5/last treatment visit of SNT-II-003 •Change in logMAR visual acuity of individual eyes compared to Visit 2/Baseline visit of SNT-II-003 •Change in logMAR visual acuity of a patient’s best eye compared to the same eye at Visit 5/last treatment visit of SNT-II-003 •Change in Health-Related Quality of Life (HRQoL) assessed by VF-14 questionnaire compared to Visit 5/last treatment visit of SNT-II-003 •Change in Health-Related Quality of Life (HRQoL) assessed by VF-14 questionnaire compared to Visit 2/Baseline visit of SNT-II-003 ;Timepoint(s) of evaluation of this end point: Single visit study

—

Countries

Canada, Germany

Contacts

Public ContactThomas Klopstock

Friedrich Baur Institut Neurologische Klinik und Poliklinik

thomas.klopstock@med.uni-muenchen.de+4989 5160 7421

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026