Amyotrophic Lateral SclerosisPhase 2/3NCT00353665
Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)
A Phase 2/3 study testing Memantine (Ebixa) and riluzole in people with Amyotrophic Lateral Sclerosis, run by University of Lisbon at 1 site in Portugal.
Trial summary
The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the progression of Amyotrophic Lateral Sclerosis (ALS). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Memantine (Ebixa) and riluzole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 sitePortugal
- Study dates
- Jul 2005to Jan 2009
- Phase
- Phase 2/3
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite or probable disease - revise El Escorial criteria
- Normal blood tests
- Riluzole treatment during 1 month or more
- EMG in accordance with El Escorial criteria
Who cannot join
- Other diseases (such as PNP)
- Both ADM muscles < 3 on MRC scale
- Conduction block on nerve conduction tests
- Disease duration > 3 years
- ALS-FRS < 25
- Forced vital capacity - <60%
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Department of Neurology - Hospital de Santa Maria
Lisbon, 1649-028
About this study
Official title: Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis
The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the single drug approved to treat ALS).
Read the detailed description
Phase 2/3 trial in ALS patients Double-blinded, parallel, randomized (2 blocs, bulbar/spinal onset)
Memantine + riluzole x Placebo + Memantine
Inclusion criteria:
- < 75 years at disease onset
- < 3 years of disease progression
- ALS-FRS > 24
- FVC > 60
- Probable or definite disease (revised El Escorial criteria)
- No other medical condition
- Normal blood tests
- Regular medication on riluzole > 1 month
- Nerve conduction studies ruling out conduction block
- EMG with widespread loss of motor units (revised El Escorial criteria)
- At least one hand with ADM strength > 2 on MRC scale
Duration - 2 years
Evaluation - every 3 months
Primary outcome - ALS-FRS Secondary -SF36, Hamilton depression scale, motor unit number estimation, neurophysiological index, strength (clinical evaluation); side-effects
Intention to treat analysis
60 patients
number estimated for 50% change in decline rate of ALS-FRS
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Memantine (Ebixa), riluzole, Placebo
- Keywords
- amyotrophic lateral sclerosis, motor neuron disease, memantine, clinical trial
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memantine (Ebixa)Drug
Also called Ebixa
10 mg bid
riluzoleDrug
Also called rilutek
riluzole 50 mg bid
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 - active | Experimental | memantine + riluzole Receives: Drug: Memantine (Ebixa); Drug: riluzole |
| 2 | Placebo comparator | riluzole + placebo Receives: Drug: riluzole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALS-FRS
Measured: 12 months
Secondary outcomes (2)
QoL, depression scale, strength (clinical evaluation), forced vital capacity
Measured: 12 months
neurophysiology (motor unit counting, neurophysiological index)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study startJul 2005
- Primary completionJun 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Investigators
- Mamede de Carvalho, MD, Principal investigator, Department of Neurology- Hospital de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353665
- Sponsor's protocol ID
- 002-04
- Status last verified
- Mar 2009
- First submitted
- 18 Jul 2006
- Last updated
- 1 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT00353665
- Acronym / sponsor ID
- 002-04
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- amyotrophic lateral sclerosis, motor neuron disease, memantine, clinical trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Jul 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Jul 2006 (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 purpose of this trial is to study the effect of Memantine (uncompetitive, moderate affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the single drug approved to treat ALS).
Detailed description
Phase 2/3 trial in ALS patients Double-blinded, parallel, randomized (2 blocs, bulbar/spinal onset)
Memantine + riluzole x Placebo + Memantine
Inclusion criteria:
- < 75 years at disease onset
- < 3 years of disease progression
- ALS-FRS > 24
- FVC > 60
- Probable or definite disease (revised El Escorial criteria)
- No other medical condition
- Normal blood tests
- Regular medication on riluzole > 1 month
- Nerve conduction studies ruling out conduction block
- EMG with widespread loss of motor units (revised El Escorial criteria)
- At least one hand with ADM strength > 2 on MRC scale
Duration - 2 years
Evaluation - every 3 months
Primary outcome - ALS-FRS Secondary -SF36, Hamilton depression scale, motor unit number estimation, neurophysiological index, strength (clinical evaluation); side-effects
Intention to treat analysis
60 patients
number estimated for 50% change in decline rate of ALS-FRS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - active | Experimental | Drug: Memantine (Ebixa), Drug: riluzolememantine + riluzole |
| 2 | Placebo comparator | Drug: riluzole, Drug: Placeboriluzole + placebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Definite or probable disease - revise El Escorial criteria
- Normal blood tests
- Riluzole treatment during 1 month or more
- EMG in accordance with El Escorial criteria
Key exclusion criteria (6 listed)
- Other diseases (such as PNP)
- Both ADM muscles < 3 on MRC scale
- Conduction block on nerve conduction tests
- Disease duration > 3 years
- ALS-FRS < 25
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 |
|---|---|---|
| Memantine (Ebixa)Also: Ebixa10 mg bid | Drug | 1 - active |
| riluzoleAlso: rilutekriluzole 50 mg bid | Drug | 1 - active, 2 |
| Placebo | Drug | 2 |
Primary outcome
ALS-FRS
Time frame: 12 months
2 secondary outcomes
QoL, depression scale, strength (clinical evaluation), forced vital capacity
Time frame: 12 months
neurophysiology (motor unit counting, neurophysiological index)
Time frame: 12 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 1 Apr 2009.
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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.
Mamede de Carvalho, MD principal investigator
Department of Neurology- Hospital de Santa Maria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Memantine (Ebixa) and riluzole in people with Amyotrophic Lateral Sclerosis, run by University of Lisbon at 1 site in Portugal.
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 4 inclusion and 6 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 1 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
ALS-FRS (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2009.