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Evolution of Albumin on AOA1 Patients Supplemented With Coenzyme Q10

NCT02333305 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-11-06

No results posted yet for this study

Summary

We propose a study on Ataxia with oculomotor apraxia type 1 (AOA1) in which Coenzyme Q10 (CoQ10) deficit has been observed. Main objectives of the study are :

* To monitor evolution of albumin in patients affected with AOA1 while supplemented with CoQ10 ;
* To measure with clinical scales and biological markers efficacy of supplementation on disease evolution.

AOA1 is characterised by Hypoalbuminemia. Disease duration is negatively correlated with albumin level. This study aims to understand mechanisms of the disease and our hypothesis is that correction or stabilization of albumin level with CoQ10 supplementation could impact disease evolution. The study is planned from 1 to 2 years supplementation. The CoQ10 is classified as a food supplement and has already been tested in other neurological conditions.

Conditions

  • Ataxia-oculomotor Apraxia 1

Interventions

DIETARY_SUPPLEMENT

CoQ10

• 2 dosages according to patient weight: Weight \< 50kg : 20 drops 3 times a day (150 mg / d) Weight ≥ 50 kg : 40 drops 3 times a day (300 mg / d)

OTHER

Sanomit Placebo

• according to patient weight: Weight \< 50kg : 20 drops 3 times a day Weight ≥ 50 kg : 40 drops 3 times a day

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Perrine Charles, MD, PhD · Assitance Publique - Hopitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02333305 on ClinicalTrials.gov