Amyotrophic Lateral SclerosisPhase 2NCT01879241
Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis
A Phase 2 study testing Rasagiline in people with Amyotrophic Lateral Sclerosis, run by University of Ulm at 15 sites in Germany.
Trial summary
The primary objective of the trial is to investigate the survival time (the time from randomization until death or end of the trial) compared between control group and experimental group. 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?
- Rasagiline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 15 sitesGermany
- Study dates
- Jun 2013to Aug 2016
- 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
- Possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria
- Disease duration more than 6 months and less than 3 years (inclusive). Disease onset defined as date of first muscle weakness, excluding fasciculations and cramps
- Vital capacity more than 50% of normal (slow vital capacity; best of three measurements)
- Age: ≥ 18 years
- Continuously treated with 100 mg riluzole for at least four weeks
- Capable of thoroughly understanding all information given and giving full informed consent according to GCP
- Women of childbearing age must be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test. Acceptable methods of birth control with a low failure rate i.e. less than 1% per year) when used consistently and correct are such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), or double-barrier methods (condom or diaphragm with spermicidal agent or IUD), sexual abstinence or vasectomized partner
Who cannot join
- Previous participation in another clinical study within the preceding 12 weeks
- Tracheostomy or assisted ventilation of any type during the preceding three months
- Gastrostomy
- Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
- Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
- Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine.
Show all 17Show fewer
- Patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphene.
- Patients on serotonin reuptake inhibitors (SSRIs). This includes fluoxetine or fluvoxamine.
- Patients on dextromethorphan, St. John's wort, cyclobenzaprine or other MAO inhibitors (selective or non-selective)
- Patients taking Antidepressants
- Confirmed hepatic insufficiency or abnormal liver function (ASAT and/or ALAT greater than 3 times the upper limit of the normal range)
- Renal insufficiency (serum creatinine more than 2.26 mg/dL)
- Evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
- Known hypersensitivity to any component of the study drug
- Liable to be not cooperative or comply with the trial requirements (as assessed by the investigator), or unable to be reached in the case of emergency
- Female with childbearing potential, if no adequate contraceptive measures are used
- Pregnancy or breast-feeding females
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Germany15 sites
Department of Neurology, Humboldt University
Berlin, 13353
Neurologische Universitätsklinik Bergmannsheil
Bochum, North Rhine-Westphalia, 44789
Department of Neurology, Universty of Bonn
Bonn, Nordrhrein-Westfalen, D-53105
Department of Neurology, TU Dresden
Dresden, Saxony, D-01307
Department of Neurology, University of Goettingen
Göttingen, Lower Saxony, D-37073
Department of Neurology, University of Halle-Wittenberg
Halle, Saxony-Anhalt, 06097
Department of Neurology, Medical School Hannover
Hanover, Lower Saxony, 30625
Department of Neurology, University of Jena
Jena, Thuringia, D-07747
Department of Neurology, Technische Universität München
Munich, Bavaria, D-81675
Department of Neurology, Universty of Muenster
Münster, North Rhine-Westphalia, D-48149
Department of Neurology, Universty of Regensburg
Regensburg, Bavaria, D-93053
Department of Neurology, University of Rostock
Rostock, Mecklenburg-Vorpommern, D-18147
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, 89081
Department of Neurology, Deutsche Klinik für Diagnostik
Wiesbaden, Hesse, D-65191
Department of Neurology, University of Wuerzburg
Würzburg, Bavaria, 91054
About this study
Official title: Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) - An AMG Trial With a Market Authorized Substance
The primary objective of the trial is to investigate the survival time (the time from randomization until death or end of the trial) compared between control group and experimental group.
This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind trial comparing placebo with 1 mg/d rasagiline as add-on therapy to 100 mg riluzole in amyotrophic lateral sclerosis (ALS) in 250 enrolled patients. For entry, the El Escorial Criteria for the diagnosis of ALS will be used. The patients have to be stable on riluzole at least 4 weeks prior to randomization.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Rasagiline, Placebo
- Keywords
- amyotrophic lateral sclerosis, survival time, ALS functioning Rating Scale, quality of life, survival
- 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.
RasagilineDrug
PlaceboDrug
a sugar pill manufactured to mimic Rasagiline 1 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Rasagiline | Experimental | Rasagiline
1 mg/day; 18 months Receives: Drug: Rasagiline |
| Placebo | Placebo comparator | once daily, 18 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival in ALS-Patients with Rasagiline compared to placebo
Measured: 18 Months
Secondary outcomes (3)
Change of total score of ALS Functional Rating Scale - Revised (ALSFRS-R)
Measured: 18 Months
Change of individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life
Measured: 18 Months
Change of slow vital capacity
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Christian Ludolph, Prof., University of Ulm
- Investigators
- Albert C. Ludolph, MD, Prof., Principal investigator, Department of Neurology, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879241
- Sponsor's protocol ID
- RAS-ALS
- Other IDs
- 2011-004482-32
- Status last verified
- Oct 2016
- First submitted
- 12 Jun 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Waibel S, Reuter A, Malessa S, Blaugrund E, Ludolph AC. Rasagiline alone and in combination with riluzole prolongs survival in an ALS mouse model. J Neurol. 2004 Sep;251(9):1080-4. doi: 10.1007/s00415-004-0481-5.
PubMed 15372249Ludolph AC, Schuster J, Dorst J, Dupuis L, Dreyhaupt J, Weishaupt JH, Kassubek J, Weiland U, Petri S, Meyer T, Grosskreutz J, Schrank B, Boentert M, Emmer A, Hermann A, Zeller D, Prudlo J, Winkler AS, Grehl T, Heneka MT, Wollebaek Johannesen S, Goricke B; RAS-ALS Study Group. Safety and efficacy of rasagiline as an add-on therapy to riluzole in patients with amyotrophic lateral sclerosis: a randomised, double-blind, parallel-group, placebo-controlled, phase 2 trial. Lancet Neurol. 2018 Aug;17(8):681-688. doi: 10.1016/S1474-4422(18)30176-5. Epub 2018 Jun 19.
PubMed 29934198
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) - An AMG Trial With a Market Authorized Substance
- ClinicalTrials.gov ID
- NCT01879241
- Acronym / sponsor ID
- RAS-ALS
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- amyotrophic lateral sclerosis, survival time, ALS functioning Rating Scale, quality of life, survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Jun 2013 (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.
The primary objective of the trial is to investigate the survival time (the time from randomization until death or end of the trial) compared between control group and experimental group.
This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind trial comparing placebo with 1 mg/d rasagiline as add-on therapy to 100 mg riluzole in amyotrophic lateral sclerosis (ALS) in 250 enrolled patients. For entry, the El Escorial Criteria for the diagnosis of ALS will be used. The patients have to be stable on riluzole at least 4 weeks prior to randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rasagiline | Experimental | Drug: RasagilineRasagiline 1 mg/day; 18 months |
| Placebo | Placebo comparator | Drug: Placeboonce daily, 18 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria
- Disease duration more than 6 months and less than 3 years (inclusive). Disease onset defined as date of first muscle weakness, excluding fasciculations and cramps
- Vital capacity more than 50% of normal (slow vital capacity; best of three measurements)
- Age: ≥ 18 years
- Continuously treated with 100 mg riluzole for at least four weeks
Key exclusion criteria (17 listed)
- Previous participation in another clinical study within the preceding 12 weeks
- Tracheostomy or assisted ventilation of any type during the preceding three months
- Gastrostomy
- Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
- Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
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 |
|---|---|---|
| Rasagiline | Drug | Rasagiline |
| Placeboa sugar pill manufactured to mimic Rasagiline 1 mg tablet | Drug | Placebo |
Primary outcome
Survival in ALS-Patients with Rasagiline compared to placebo
Time frame: 18 Months
3 secondary outcomes
Change of total score of ALS Functional Rating Scale - Revised (ALSFRS-R)
Time frame: 18 Months
Change of individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life
Time frame: 18 Months
Change of slow vital capacity
Time frame: 18 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 25 Oct 2016.
- Background: PubMed 15372249Waibel S, Reuter A, Malessa S, Blaugrund E, Ludolph AC. Rasagiline alone and in combination with riluzole prolongs survival in an ALS mouse model. J Neurol. 2004 Sep;251(9):1080-4. doi: 10.1007/s00415-004-0481-5.
- Derived from this study: PubMed 29934198Ludolph AC, Schuster J, Dorst J, Dupuis L, Dreyhaupt J, Weishaupt JH, Kassubek J, Weiland U, Petri S, Meyer T, Grosskreutz J, Schrank B, Boentert M, Emmer A, Hermann A, Zeller D, Prudlo J, Winkler AS, Grehl T, Heneka MT, Wollebaek Johannesen S, Goricke B; RAS-ALS Study Group. Safety and efficacy of rasagiline as an add-on therapy to riluzole in patients with amyotrophic lateral sclerosis: a randomised, double-blind, parallel-group, placebo-controlled, phase 2 trial. Lancet Neurol. 2018 Aug;17(8):681-688. doi: 10.1016/S1474-4422(18)30176-5. Epub 2018 Jun 19.
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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.
Albert C. Ludolph, MD, Prof. principal investigator
Department of Neurology, University of Ulm
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rasagiline in people with Amyotrophic Lateral Sclerosis, run by University of Ulm at 15 sites in Germany.
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 7 inclusion and 17 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 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany. 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?
Survival in ALS-Patients with Rasagiline compared to placebo (time frame: 18 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 NCT01879241, which also lists 2 linked publications.
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 25 Oct 2016.