PHENOGENE-1A (Cromolyn) for Mild to Moderate ALS
This study is testing a drug called PHENOGENE-1A (Cromolyn Sodium) for people with mild to moderate Amyotrophic Lateral Sclerosis (ALS). Researchers want to see if PHENOGENE-1A can help improve your daily function, measured by the ALS Functional Rating Scale Revised (ALSFRS-R), and lung function. You would receive PHENOGENE-1A or a placebo (an inactive substance) through an inhaler twice a day for 24 weeks, while continuing your standard Riluzole treatment. To join, you need to be between 18 and 75 years old and have a confirmed ALS diagnosis. The study is currently enrolling 105 participants, but its status is unclear.
- Study design
- This is a Phase IIB, randomized, double-blind, placebo-controlled study involving 105 participants. You would be randomly assigned to receive a low dose of PHENOGENE-1A, a high dose of PHENOGENE-1A, or a placebo.
- What's involved
- You would take PHENOGENE-1A or a placebo via a dry powder inhaler twice a day for 24 weeks. You must also continue your Riluzole treatment throughout this period.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures changes in your condition and any side effects from the start of the study until Week 24.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS
At a glance
Conditions
NCT07142291
Where you'd take part
This study runs at 22 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Barcelona Sea Hospital (Hospital Del Mar De Barcelona)
Barcelona, Spainno site contact published
Recruiting
Centrum Medyczne NeuroProtect (NeuroProtect Medical Center)
Warsaw, Polandno site contact published
Recruiting
Charité Centrum für Neurologie, Neurochirurgie und Psychiatrie
Berlin, Germanyno site contact published
Recruiting
City Clinic Research
Warsaw, Polandno site contact published
Recruiting
DIAKOVERE Henriettenstift - Klinik für Neurologie und Klinische Neurophysiologie
Hanover, Germanyno site contact published
Recruiting
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechiano site contact published
Recruiting
Honor Health Neurology - Bob Bove Neuroscience Institute
Scottsdale, Arizonano site contact published
Recruiting
Hospital General Universitario Dr. Balmis de Alicante
Alicante, Spainno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Absolute change in ALSFRS-R total score from baseline to Week 24Baseline to Week 24
To evaluate the effects of PHENOGENE-1A (cromolyn) on functional changes in subjects with mild to moderate ALS using the ALS Functional Rating Scale-Revised (ALSFRS-R).
- Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)Baseline to Week 24
To evaluate the safety of PHENOGENE-1A following 24 weeks of twice daily (BID) treatment.