Trial · NCT02487407
Effects of ODM-109 on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis
NCT02487407, Phase 2, Completed, Orion Corporation, Orion Pharma
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of ODM-109 on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis. Trials, record NCT02487407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02487407
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of ODM-109 on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis
- NCT number
- NCT02487407
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- Orion Corporation, Orion Pharma
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- ODM-109, Placebo for ODM-109
- First posted
- 2015-07-01
- Last updated
- 2017-11-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Slow vital capacity SVC | 9 months | Pulmonary assessment |
| Secondary | Hand grip strength and submaximal hand grip strength endurance | 3 months | Assessment |
| Secondary | Changes in subject's clinical condition (relative to the baseline/day 1 of the given treatment period) will be assessed using the Clinical Global Impression of Change (CGI-C) | 3 months | Scales |
| Secondary | Quality of life | 9 months | Questionnaire |
| Secondary | Revised ALS Functional Rating Scale ALSFRS-R | 9 months | Scale |
| Secondary | Oxygen saturation | 9 months | Assessment |
| Secondary | The concentrations of ODM-109, OR-1855 and OR-1896 | 3 months | Pharmacokinetics Blood samples. |
| Secondary | Determination of subject's acetylation status | 1 day (once at baseline) | Pharmacogenomics Blood samples. |
| Secondary | Sniff nasal pressure SNP | 9 months | SNP will be assessed in sitting position. SNP will be performed for 10 times. The highest value (cmH2O) measured will be the SNP variable. |
| Secondary | Fatigue assessment | 3 months | Visual analogue Scale VAS |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31315908 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02487407
GET https://conductscience.org/api/trials/v1/NCT02487407/registered