Effect of Bezafibrate on muscle metabolism during exercise in patients with fat metabolic disorders in skeletal muscle - Bezafibrate study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006704-27-DK

Enrollment

Registered

2009-06-03

Start date

2009-07-17

Completion date

Unknown

Last updated

2021-08-02

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

Conditions

Evaluation of the effect of Bezafibrate on muscle metabolism during exercise in patients with VLCAD and CPT II deficiency MedDRA version: 12.0 Level: LLT Classification code 10029316 Term: Neuromuscular disorder NOS

Interventions

Trade Name: Bezafibrate Product Name: Bezafibrate Product Code: PL00031/0523 Pharmaceutical Form: Coated tablet INN or Proposed INN: BEZAFIBRATE CAS Number: 41859670 Concentration unit: mg milligram(s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Significant decrease in the CPT II or VLCAD activities measured in lymphocytes or fibroblasts, together with genetic verification of either CPT II deficiency or VLCAD deficiency. 2. Males and females age 18-65 years. 3. All fertile females have to have a negative pregnancy test and use anti-conceptive during the study period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Ingestion of competitive drugs, as described in the product resume of bezafibrate. 2. Competitive disorders, evaluated by the sponsor or investigators 3. Pregnancy or lactation during the period of fibrate therapy

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Secondary outcomes: § Enzyme activity in leucocytes § Acylcarnitine profile § Accelerometer § Borg score (perceived exertion) § Number of episodes of myoglobinuria § Daily muscle pain score (VAS) § Daily diary of energy utilization (Bouchards questionnaire) ;Primary end point(s): The two primary outcomes to asses the potential effect of Bezafibrate is § Fat oxidation and heart rate generated during physical activity on cycle ergometer at a constant workload We expect the fat oxidation in the patients to increase by a factor 1.7. ;Main Objective: The two primary outcomes to asses the potential effect of Bezafibrate is § Fat oxidation and heart rate generated during physical activity on cycle ergometer at a constant workload We expect the fat oxidation in the patients to increase by a factor 1.7.	—

Measure

Time frame

Secondary Objective: Secondary outcomes: § Enzyme activity in leucocytes § Acylcarnitine profile § Accelerometer § Borg score (perceived exertion) § Number of episodes of myoglobinuria § Daily muscle pain score (VAS) § Daily diary of energy utilization (Bouchards questionnaire) ;Primary end point(s): The two primary outcomes to asses the potential effect of Bezafibrate is § Fat oxidation and heart rate generated during physical activity on cycle ergometer at a constant workload We expect the fat oxidation in the patients to increase by a factor 1.7. ;Main Objective: The two primary outcomes to asses the potential effect of Bezafibrate is § Fat oxidation and heart rate generated during physical activity on cycle ergometer at a constant workload We expect the fat oxidation in the patients to increase by a factor 1.7.

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Countries

Denmark

Outcome results

None listed

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