Amyotrophic Lateral Sclerosis Clinical Trial
— MetFlexOfficial title:
Targeting Metabolic Flexibility in ALS (MetFlex); Safety and Tolerability of Trimetazidine for the Treatment of ALS
NCT number | NCT04788745 |
Other study ID # | MetFlex |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 29, 2021 |
Est. completion date | May 24, 2023 |
Verified date | November 2022 |
Source | The University of Queensland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
MetFlex is an investigator led, open-label, single-arm, Phase 2a trial to determine the safety and tolerability of trimetazidine for the treatment of amyotrophic lateral sclerosis/motor neuron disease (ALS/MND).
Status | Completed |
Enrollment | 21 |
Est. completion date | May 24, 2023 |
Est. primary completion date | May 24, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age between 18 and 75 years - Signed informed consent prior to the initiation of any study-specific procedures - Familial or sporadic ALS/MND, defined as clinically possible, probable, or definite as per the El Escorial criteria - Relative TRICALS risk score between -6.0 to -2.0 (75% of patients with ALS/MND) - Metabolic index =110%, at the screening visit. - The use of riluzole will be permitted during the study. Individuals taking riluzole must be on a stable dose for at least 30 days prior to the baseline visit, or stopped taking riluzole at least 30 days prior to the baseline visit. - Ability to swallow tablets - Able to lie with torso elevated at a 35° angle for 30 minutes without respiratory support - Able to give informed consent (as judged by the investigator) and able to comply with all study visits and all study procedures - Females must not be able to become pregnant (e.g. post-menopausal, surgically sterile or using highly effective birth control methods) for the duration of the study. Highly effective methods of birth control are those with a failure rate of < 1% per year when employed consistently and correctly, e.g. Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: - oral - intravaginal - transdermal - Progestogen-only hormonal contraception associated with inhibition of ovulation: - oral - injectable - implantable - intrauterine device (IUD) - intrauterine hormone-releasing system ( IUS) - vasectomised partner - Females of child-bearing potential must have a negative serum pregnancy test at screening and baseline and be non-lactating Exclusion Criteria: - Unable to provide informed consent - History of, or current diagnosis of diabetes or medical condition that impacts whole body energy expenditure (e.g. Hashimoto's, heart disease) - Parkinson's disease or parkinsonism, tremor, restless-leg syndrome - Safety Laboratory Criteria at screening related to significant kidney disease: - Creatinine clearance < 50 mL / min (Cockcroft-Gault) based on Cystatin C - Tracheostomy or non-invasive ventilation (NIV) use > 22 hours per day - Inability to swallow tablets - Contraindication therapy: - Allergy for one of the product's active pharmaceutical ingredients (APIs) or excipients. - Antihypertensive treatment [Trimetazidine may cause hypotension] - Evidence of malignant disease - Significant neuromuscular disease other than ALS/MND - Ongoing disease that may cause neuropathy - Pregnancy or breastfeeding - Females actively seeking to become pregnant who are not using an adequate form of contraceptive as detailed in the Inclusion criteria. - Deprivation of freedom by administrative or court order |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Brisbane & Women's Hospital | Brisbane | Queensland |
Netherlands | University Medical Centre Utrecht | Utrecht | |
United Kingdom | King's College London | London |
Lead Sponsor | Collaborator |
---|---|
The University of Queensland | FightMND, Julius Clinical, King's College London, UMC Utrecht |
Australia, Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events; Safety and Tolerability | The occurrence of adverse events, as assessed by Common Terminology Criteria for AEs Version 5, during the 12-week on-treatment period and 4-week wash-out period (16 weeks total). | 16 weeks | |
Primary | Level of expression of oxidative stress markers in the plasma and/or serum of trial participants | Expression of oxidative stress markers (malondialdehyde, 8-hydroxy-2'-deoxyguanosine, interleukin-6; assessed by liquid chromatography-mass spectrometry/mass-spectrometry or multiplexing) in the plasma and/or serum of trial participants throughout the treatment period (12-week) and at the end of the wash-out period (4 weeks) | 16 weeks | |
Secondary | Level of expression of oxidative stress markers in the plasma and/or serum of trial participants to inform future clinical trials in ALS/MND | Assessment of the expression of oxidative stress markers (malondialdehyde, 8-hydroxy-2'-deoxyguanosine, interleukin-6; assessed by liquid chromatography-mass spectrometry/mass-spectrometry or multiplexing) in the plasma and/or serum of trial participants throughout the treatment period (12-week) and at the end of the wash-out period (4 weeks) to determine suitability for incorporation into future trial design | 16 weeks |
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