Amyotrophic Lateral SclerosisPhase 2ALSNCT02487407
Effects of ODM-109 on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis
A Phase 2 study testing ODM-109 in people with Amyotrophic Lateral Sclerosis, run by Orion Corporation, Orion Pharma at 11 sites in 4 countries.
Trial summary
In the double-blind, cross-over part of the study, ODM-109 capsules and placebo capsules for ODM-109 will be administered for 2 weeks separated by a 19-23 days wash-out period. During each treatment period of the double-blind cross-over part, there will be a baseline visit (day 1) and 2 visits (5 ± 2 and 14 ± 2 days)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- ODM-109
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Jul 2015to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent (IC) for participation in the study will be obtained from the subject (or from the subject's next of kin, caregiver, or other legally acceptable representative in case the study subject him/herself cannot sign the IC due to severe muscle weakness).
- Age of at least 18 years.
- Male or female subjects with diagnosis of laboratory supported probable, probable or definite ALS according to El Escorial revised criteria (Brooks BR et al., 2000). Full electromyogram (EMG) report available compatible with ALS according to an experienced neurophysiologist.
- Ability to swallow the study treatment capsules.
- An upright (sitting position) SVC between 60-90% of the predicted value for age, height and sex at screening visit.
- Normal oxygen saturation during daytime (measure of ≥ 95% when steady state has been reached with a reliable read) in sitting position measured by pulse oximetry.
- Disease duration from symptom onset (defined by first muscle weakness or dysarthria) of 12-48 months.
- Using riluzole. The dose must have been stable for at least 4 weeks prior to screening at a dose of 50 mg b.i.d.
Who cannot join
- Subject in whom other causes of neuromuscular weakness have not been excluded.
- Subject with a diagnosis of another neurodegenerative disease (e.g. Parkinson's or Alzheimer's disease).
- Assisted ventilation or gastrostomy of any type during the preceding 3 months prior to screening or predicted to be required within the randomised, double-blind cross-over part of the study.
- Recorded diagnosis or evidence of major psychiatric diagnosis, significant cognitive impairment or clinically evident dementia.
- Any major surgery within 1 month before the screening visit or patients who are scheduled for any major surgery during the planned study period.
- Potassium < 3.7 mmol/l or > 5.5 mmol/l at screening.
Show all 19Show fewer
- Creatinine > 170 μmol/l at screening or on dialysis.
- Blood haemoglobin < 10 g/dl at screening.
- Clinically significant hepatic impairment at the discretion of the investigator.
- Women of reproductive age without a negative pregnancy test and without a commitment to using an acceptable method of barrier or hormonal contraception (e.g. condoms, diaphragms, oral contraceptives and long acting progestin agents), if sexually active during the study, and for 1 month after the last dose of the study treatment. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be reproductive and can be included.
- Known hypersensitivity to levosimendan.
- Administration of levosimendan within 30 days prior to screening visit.
- Patients with history of botulinum toxin treatment for any reason.
- Patients with known history of human immunodeficiency virus infection.
- History of significant arrhythmias or other cardiac events
- Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator could interfere with the interpretation of the study results or constitute a health risk for the subject if he/she took part in the study.
- Blood donation or loss of significant amount of blood within 60 days prior to screening.
- Participation in a clinical trial with any experimental treatment within 30 days prior to the screening visit or previous participation in the present study.
- Any other condition that in the opinion of the investigator could interfere with the interpretation of the study results or constitute a health risk for the subject if he/she took part in the study.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United Kingdom5 sites
Royal Sussex County Hospital
Brighton
The Walton Centre
Liverpool
London Kings College Hospital
London
Royal London Hospital
London
University of Sheffield
Sheffield
Germany4 sites
Charite Universitatsmedizin Berlin
Berlin
Medical School Hannover
Hanover
University Clinical Jena
Jena
University Hospital of Ulm
Ulm
About this study
Official title: Effects of ODM-109 on Respiratory Function in Patients With ALS. A Randomized, Double Blind, Placebo-controlled, Cross-over, 3-period, Multicenter Study With Open-label Follow-up Extension
In the double-blind, cross-over part of the study, ODM-109 capsules and placebo capsules for ODM-109 will be administered for 2 weeks separated by a 19-23 days wash-out period. During each treatment period of the double-blind cross-over part, there will be a baseline visit (day 1) and 2 visits (5 ± 2 and 14 ± 2 days) after the start of study treatment. After completing the 3rd treatment period, the subjects will continue in the open-label follow-up part for 6 months. During the open-label follow-up, visits will be at 1, 3 and 6 months. An end-of-study visit will take place 14-25 days after the last study treatment administration for each subject. The study duration will be about 13-14 weeks for the double-blind cross-over part, and about 9-10 months for the entire study including the 6 months open-label follow-up.
The number of randomised study subjects is planned to be approximately 54 in cross-over comparison. The maximum number of subjects will not exceed 70.
Primary objective is to investigate the efficacy of oral ODM-109 on respiratory function in patients with amyotrophic lateral sclerosis (ALS).
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- ODM-109, Placebo for ODM-109
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-109Drug
Also called Levosimendan
ODM-109 1 mg capsule for oral administration.
Placebo for ODM-109Drug
Also called Placebo for Levosimendan
Placebo capsule for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| ODM-109 | Experimental | ODM-109 capsules for oral administration Receives: Drug: ODM-109; Drug: Placebo for ODM-109 |
| Placebo for ODM-109 | Placebo comparator | Placebo ODM-109 capsules for oral administration Receives: Drug: ODM-109; Drug: Placebo for ODM-109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slow vital capacity SVC
Pulmonary assessment
Measured: 9 months
Secondary outcomes (9)
Hand grip strength and submaximal hand grip strength endurance
Assessment
Measured: 3 months
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)
Scales
Measured: 3 months
Quality of life
Questionnaire
Measured: 9 months
Revised ALS Functional Rating Scale ALSFRS-R
Scale
Measured: 9 months
Oxygen saturation
Assessment
Measured: 9 months
The concentrations of ODM-109, OR-1855 and OR-1896
Pharmacokinetics Blood samples.
Measured: 3 months
Determination of subject's acetylation status
Pharmacogenomics Blood samples.
Measured: 1 day (once at baseline)
Sniff nasal pressure SNP
SNP will be assessed in sitting position. SNP will be performed for 10 times. The highest value (cmH2O) measured will be the SNP variable.
Measured: 9 months
Fatigue assessment
Visual analogue Scale VAS
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merja Mäkitalo, CSD, Study director, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487407
- Sponsor's protocol ID
- 3119001
- Acronym
- ALS
- Status last verified
- Aug 2016
- First submitted
- 8 Jun 2015
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Al-Chalabi A, Shaw P, Leigh PN, van den Berg L, Hardiman O, Ludolph A, Aho VV, Sarapohja T, Kuoppamaki M. Oral levosimendan in amyotrophic lateral sclerosis: a phase II multicentre, randomised, double-blind, placebo-controlled trial. J Neurol Neurosurg Psychiatry. 2019 Oct;90(10):1165-1170. doi: 10.1136/jnnp-2018-320288. Epub 2019 Jul 17.
PubMed 31315908
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of ODM-109 on Respiratory Function in Patients With ALS. A Randomized, Double Blind, Placebo-controlled, Cross-over, 3-period, Multicenter Study With Open-label Follow-up Extension
- ClinicalTrials.gov ID
- NCT02487407
- Acronym / sponsor ID
- ALS / 3119001
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the double-blind, cross-over part of the study, ODM-109 capsules and placebo capsules for ODM-109 will be administered for 2 weeks separated by a 19-23 days wash-out period. During each treatment period of the double-blind cross-over part, there will be a baseline visit (day 1) and 2 visits (5 ± 2 and 14 ± 2 days) after the start of study treatment. After completing the 3rd treatment period, the subjects will continue in the open-label follow-up part for 6 months. During the open-label follow-up, visits will be at 1, 3 and 6 months. An end-of-study visit will take place 14-25 days after the last study treatment administration for each subject. The study duration will be about 13-14 weeks for the double-blind cross-over part, and about 9-10 months for the entire study including the 6 months open-label follow-up.
The number of randomised study subjects is planned to be approximately 54 in cross-over comparison. The maximum number of subjects will not exceed 70.
Primary objective is to investigate the efficacy of oral ODM-109 on respiratory function in patients with amyotrophic lateral sclerosis (ALS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ODM-109 | Experimental | Drug: ODM-109, Drug: Placebo for ODM-109ODM-109 capsules for oral administration |
| Placebo for ODM-109 | Placebo comparator | Drug: ODM-109, Drug: Placebo for ODM-109Placebo ODM-109 capsules for oral administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent (IC) for participation in the study will be obtained from the subject (or from the subject's next of kin, caregiver, or other legally acceptable representative in case the study subject him/herself cannot sign the IC due to severe muscle weakness).
- Age of at least 18 years.
- Male or female subjects with diagnosis of laboratory supported probable, probable or definite ALS according to El Escorial revised criteria (Brooks BR et al., 2000). Full electromyogram (EMG) report available compatible with ALS according to an experienced neurophysiologist.
- Ability to swallow the study treatment capsules.
- An upright (sitting position) SVC between 60-90% of the predicted value for age, height and sex at screening visit.
Key exclusion criteria (19 listed)
- Subject in whom other causes of neuromuscular weakness have not been excluded.
- Subject with a diagnosis of another neurodegenerative disease (e.g. Parkinson's or Alzheimer's disease).
- Assisted ventilation or gastrostomy of any type during the preceding 3 months prior to screening or predicted to be required within the randomised, double-blind cross-over part of the study.
- Recorded diagnosis or evidence of major psychiatric diagnosis, significant cognitive impairment or clinically evident dementia.
- Any major surgery within 1 month before the screening visit or patients who are scheduled for any major surgery during the planned study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ODM-109Also: LevosimendanODM-109 1 mg capsule for oral administration. | Drug | ODM-109, Placebo for ODM-109 |
| Placebo for ODM-109Also: Placebo for LevosimendanPlacebo capsule for oral administration. | Drug | ODM-109, Placebo for ODM-109 |
Primary outcome
Slow vital capacity SVC
Time frame: 9 months
Pulmonary assessment
9 secondary outcomes
Hand grip strength and submaximal hand grip strength endurance
Time frame: 3 months
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)
Time frame: 3 months
Quality of life
Time frame: 9 months
Revised ALS Functional Rating Scale ALSFRS-R
Time frame: 9 months
Oxygen saturation
Time frame: 9 months
The concentrations of ODM-109, OR-1855 and OR-1896
Time frame: 3 months
Determination of subject's acetylation status
Time frame: 1 day (once at baseline)
Sniff nasal pressure SNP
Time frame: 9 months
Fatigue assessment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Derived from this study: PubMed 31315908Al-Chalabi A, Shaw P, Leigh PN, van den Berg L, Hardiman O, Ludolph A, Aho VV, Sarapohja T, Kuoppamaki M. Oral levosimendan in amyotrophic lateral sclerosis: a phase II multicentre, randomised, double-blind, placebo-controlled trial. J Neurol Neurosurg Psychiatry. 2019 Oct;90(10):1165-1170. doi: 10.1136/jnnp-2018-320288. Epub 2019 Jul 17.
Related trials for Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merja Mäkitalo, CSD study director
Finland
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ODM-109 in people with Amyotrophic Lateral Sclerosis, run by Orion Corporation, Orion Pharma at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, Germany, Ireland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slow vital capacity SVC (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02487407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.