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A randomized, phase II/III trial on the biological and clinical effects of acetyl-L-carnitine in ALS
EU CTIS ID: 2023-509853-29-00
What this study is testing
Assess the efficacy of acetyl-L-carnitine (ALCAR) (two different dosages will be tested: 1.5g/day and 3g/day) on the progression of functional disability (loss of self-sufficiency), as measured by the ALSFRS-R scale
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18+;
- Intact cognitive function, again determined by the Principal Investigator.
- ALS diagnosis according to the Gold Coast Criteria
- Disease duration ≤ 24 months from symptom onset, as indicated by limb weakness or bulbar symptoms, at the randomization/baseline visit
- Self-sufficiency [Satisfactory bulbar and spinal function (score 3+ on the ALSFRS-R for swallowing, cutting food and handling utensils, and walking)];
- Satisfactory respiratory function (FVC ≥70% of predicted);
You likely can't join if
- Antecedent polio infection or other active infection;
- Unwillingness or inability to take riluzole.
- Motor neuron disease (MND) other than ALS;
- Involvement of other systems possibly determining a functional impairment (as measured by the endpoints) for the entire duration of the study;
- Other severe clinical conditions (e.g., cardiovascular disorders, neoplasms) with an impact on survival or functional disability in the next 12 months;
- Previous use of ALCAR for more than 6 weeks. In case of previous use of ALCAR, 7 days of wash-out period must be performed before enrolling the participant;
See the full eligibility criteria
- Age 18+;
- Intact cognitive function, again determined by the Principal Investigator.
- ALS diagnosis according to the Gold Coast Criteria
- Disease duration ≤ 24 months from symptom onset, as indicated by limb weakness or bulbar symptoms, at the randomization/baseline visit
- Self-sufficiency [Satisfactory bulbar and spinal function (score 3+ on the ALSFRS-R for swallowing, cutting food and handling utensils, and walking)];
- Satisfactory respiratory function (FVC ≥70% of predicted);
- Documented progression of symptoms as measured by the ALSFRS-R scale. Disease progression rate (DFS) must be>= 0.33. DFS =(48- ALSFRS-R at screening)/months from onset to screening OR documented progression of symptoms in the last three months as measured by the ALSFRS-R scale (decrease of at least one point in the last three months)
- Ability to understand and comply with the study requirements;
- Ability to give written informed consent personally or, as an alternative, via a legally authorized representative;
- Treatment with riluzole 50 mg twice/day for at least 4 weeks prior to randomization visit;
- Antecedent polio infection or other active infection;
- Unwillingness or inability to take riluzole.
- Motor neuron disease (MND) other than ALS;
- Involvement of other systems possibly determining a functional impairment (as measured by the endpoints) for the entire duration of the study;
- Other severe clinical conditions (e.g., cardiovascular disorders, neoplasms) with an impact on survival or functional disability in the next 12 months;
- Previous use of ALCAR for more than 6 weeks. In case of previous use of ALCAR, 7 days of wash-out period must be performed before enrolling the participant;
- Poor compliance with previous treatments;
- Other experimental treatments in the three months prior to the screening visit (if a subject is receiving another experimental drug, a 3-month wash-out period before participating in the present clinical trial will be required);
- Women who are lactating or able to become pregnant (e.g. who are not post-menopausal, surgically sterile, or using inadequate birth control) and men unable to practice contraception for the duration of the treatment and three months after its completion;
- Inability to understand and comply with the study requirements;
The study team makes the final eligibility decision.
Where it's taking place
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.