Trial · NCT07142291
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute change in ALSFRS-R total score from baseline to Week 24 | Baseline 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). |
| Primary | 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. |
| Secondary | Mean rank for CAFS at Week 24 | Baseline to Week 24 | To evaluate the effects of PHENOGENE-1A on function and survival using the Combined Assessment of Function and Survival (CAFS). |
| Secondary | Time to event requiring full-time or nearly full-time respiratory support | Randomization to Week 24 | Time from randomization to the first of 7 consecutive days on which permanent assisted ventilation (invasive or non-invasive) was used for \>22 hours/day due to ALS progression. |
| Secondary | Mean change in percent predicted forced vital capacity (%FVC) from baseline to Week 24 | Baseline to Week 24 | To evaluate the effect of PHENOGENE-1A on respiratory changes. |
| Secondary | Mean change in peak inspiratory flow rate (PIFR) from baseline to Week 24 | Baseline to Week 24 | To evaluate changes in PIFR (L/min) during treatment. |
| Secondary | Absolute Values and Changes From Baseline in Vital Signs From Baseline to Week 24 by Treatment Arm | Baseline to Week 24 | Vital signs will include: * Systolic blood pressure (mmHg) * Diastolic blood pressure (mmHg) * Pulse rate (beats per minute) * Respiratory rate (breaths per minute) * Body temperature (°C or °F, as recorded) Results will be summarized as: * Absolute values for each parameter at each scheduled visit. * Changes from baseline at each visit. * Summaries will be presented separately by treatment arm. |
| Secondary | Number and Percentage of Subjects With Abnormal Clinical Laboratory Values and Changes From Baseline to Week 24 by Treatment Arm | Baseline to Week 24 | Safety laboratory assessments will include hematology, clinical chemistry, coagulation, and urinalysis panels. Each laboratory result will be classified as normal, abnormal (not clinically significant), or abnormal (clinically significant). Results will be summarized as: Number and percentage of subjects with abnormal laboratory values at each post-baseline visit, by treatment arm. Summary statistics for absolute values and changes from baseline at each visit. |
| Secondary | Number and Percentage of Subjects With Abnormal Physical Examination Findings From Baseline to Week 24 by Treatment Arm | Baseline to Week 24 | The physical examination will assess head/neck, eyes, ears, nose/throat, cardiovascular, respiratory, abdominal, musculoskeletal, extremities, and skin systems. Each system will be classified as normal, abnormal (not clinically significant), or abnormal (clinically significant). Results will be summarized as the number and percentage of subjects with abnormal findings at each post-baseline visit. |
| Secondary | Number and Percentage of Subjects With Abnormal Neurological Examination Findings From Baseline to Week 24 by Treatment Arm | Baseline to Week 24 | The neurological examination will assess mental status, motor function, sensory function, reflexes, and coordination/cerebellar function. Each domain will be classified as normal, abnormal (not clinically significant), or abnormal (clinically significant). Results will be summarized as the number and percentage of subjects with abnormal findings at each post-baseline visit. |
| Secondary | Number and Percentage of Subjects With Abnormal Electrocardiogram (ECG) Findings From Baseline to Week 24 by Treatment Arm | Baseline to Week 24 | Standard 12-lead ECGs will be performed at protocol-specified visits. Parameters assessed will include: * Heart rate: 60-100 beats per minute (bpm) * PR interval: 120-200 milliseconds (ms) * QRS duration: 70-110 ms * QT interval: \< 440 ms in men, \< 460 ms in women * Corrected QT interval (QTcF, Fridericia's formula): \< 450 ms in men, \< 470 ms in women Each ECG result will be classified by the investigator as normal, abnormal (not clinically significant), or abnormal (clinically significant), using these ranges as reference. Results will be summarized as the number and percentage of subjects with abnormal ECG findings at each post-baseline visit. |
| Secondary | Number and Percentage of Subjects With Suicidal Ideation, Suicidal Behavior, or Self-Injurious Behavior Without Suicidal Intent on the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 24 by Treatment Arm | Baseline to Week 24 | The Columbia Suicide Severity Rating Scale (C-SSRS) will be administered at protocol-specified visits to assess suicidal ideation, suicidal behavior, and self-injurious behavior without suicidal intent. * Suicidal ideation will be captured using categories 1-5 of the C-SSRS (ranging from passive wish to be dead to active suicidal ideation with plan and intent). * Suicidal behavior will be captured using categories 6-10 of the C-SSRS (preparatory acts, aborted attempts, interrupted attempts, and actual attempts). * Self-injurious behavior without suicidal intent will be reported separately. Results will be summarized as: Number and percentage of subjects with suicidal ideation, suicidal behavior, and self-injurious behavior without suicidal intent, compared between active treatment and placebo arms. |
| Secondary | Number and Percentage of Subjects Who Discontinue Study Participation Due to Adverse Events From Baseline to Week 24 | Baseline to Week 24 | The incidence of study discontinuation attributed to treatment-emergent adverse events (TEAEs) will be assessed. Results will be summarized as the number and percentage of subjects who withdraw from the study due to an adverse event, presented separately by treatment arm. |
| Other | Change in plasma neuroinflammatory biomarkers from baseline to Week 24 | Baseline (pre-dose) to Week 24 | To evaluate the impact of two different doses of PHENOGENE-1A on neuroinflammation. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07142291/registered