Amyotrophic Lateral SclerosisPhase 3DOSERALNCT01160263
Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls
A Phase 3 study testing SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM in people with Amyotrophic Lateral Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The purpose of this study is to study the transporters of serotonin and dopamine in ALS patients in relation with the clinical phenotype, i.e., patients without stiffness, patients with pyramidal stiffness, patients with mixed (pyramidal and extra pyramidal) stiffness. Read more about this study
- Who is it for?
- Ages 39 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2012to Oct 2014
- Phase
- Phase 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 39 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients (men or women)
- between 39 (exclusive) and 66 (inclusive) years old
- with a sporadic ALS, defined, probable or laboratory possible
- with a disease duration between 3 months (inclusive) and 5 years (exclusive)
- treated with rilutek at 100 mg/ day since at least 1 month
- Patients will be assigned in three groups in relation with the clinical phenotypes:
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- 20 patients without stiffness
- 20 patients with pyramidal stiffness (spasticity patients).
- 20 patients with mixed stiffness (both spasticity and rigidity).
- Patients have to be capable of thoroughly understanding the information given; have signed the informed consent form (signature of spouse or family relative or acceptable third party is acceptable if the patient is physically unable to sign).
- To have social insurance
Who cannot join
- Patients with a FRONTO temporal dementia (according to NEARY' criteria)
- Patients with any concomitant life-threatening disease or any disease or impairment likely to interfere with functional assessment;
- Patients with any major evolving psychiatric disorder or major anxiety disorder according to DSM-IV criteria (APA, 1996)
- Patients receiving treatments which could interfere with the serotonin or dopamine metabolism
- Patients with contraindications for the dat-scan and /or ADAM scan
- Patients with contraindications for the MRI scan.
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- Patients with previous vascular, traumatic or tumoral cerebral lesions making impossible the quantification of the tracer
- Patients with a cancer within the past 5
- Patients child bearing, breast feeding or in the second part of their cycle without any efficient contraceptive device or treatment
- Patients liable not to be co-operative or comply with the trial requirements (as assessed by the investigator), or unable to be reached in the event of an emergency;
Trial locations and contacts
2 sites in 1 country.
France2 sites
Salpêtrière Hospital
Paris, 75013
Bretonneau Hospital
Tours, 37044
About this study
Official title: Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls. Analysis With 123I-FP-CIT (Datscan) and 123I-ADAM Brain SPECT
The purpose of this study is to study the transporters of serotonin and dopamine in ALS patients in relation with the clinical phenotype, i.e., patients without stiffness, patients with pyramidal stiffness, patients with mixed (pyramidal and extra pyramidal) stiffness.
For such a goal the investigators will use SPECT to compare the binding of two specific tracers in ALS patients and in matched healthy controls.
Read the detailed description
Study design This study is a prospective cross-sectional controlled multicentric clinical study in 60 ALS patients and 20 controls.
Three cohorts of 20 ALS patients(patients without stiffness, patients with pyramidal stiffness, patients with mixed pyramidal and extra pyramidal stiffness) and 20 healthy controls will be included in this study
Study centres 40 ALS patients and 13 controls will be included in the Paris ALS center, 20 ALS patients and 7 controls will be included in the Tours ALS center.
MRI will be performed at the Neuroradiology department of salpetriere hospital (Paris) and Bretonneau hospital (Tours) SPECT will be done in the nuclear medicine center of each hospital (Paris- Tours).
Study duration Per patient or control, the study will be lasted one month. The total study duration will be two years
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
- Keywords
- ALS, serotonin, dopamine
- 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.
SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAMDrug
Also called PECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
123 I-FP-CIT (DATSCAN) : 185 MBq (5 mCi), 2,5 ml will be injected via an arm intravenous catheter.
123I-ADAM:185 MBq,5 ml will be injected via an arm intravenous catheter.
| Study group | Role | What they receive |
|---|---|---|
| patients without stiffness | Other | Not described Receives: Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM |
| patients with pyramidal stiffness | Other | Not described Receives: Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM |
| patients with mixed stiffness | Other | Not described Receives: Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dopamine transporter binding potential
Measured: 1 month
Secondary outcomes (2)
Serotonin transporter binding potential
Measured: 1 month
Relationships between transporter binding potential and the clinical scores
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startOct 2012
- Primary completionOct 2014
- Study completionOct 2014
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris, ARS (Association pour la Recherche sur la Sclérose Latérale Amyotrophique), Agence Générale des Equipements et Produits de Santé
- Responsible party
- Sponsor
- Investigators
- Lucette Lacomblez, MD, Principal investigator, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160263
- Sponsor's protocol ID
- P080402
- Other IDs
- P080402, AOM 07225
- Acronym
- DOSERAL
- Status last verified
- May 2015
- First submitted
- 9 Jul 2010
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls. Analysis With 123I-FP-CIT (Datscan) and 123I-ADAM Brain SPECT
- ClinicalTrials.gov ID
- NCT01160263
- Acronym / sponsor ID
- DOSERAL / P080402
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- ALS, serotonin, dopamine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris, ARS (Association pour la Recherche sur la Sclérose Latérale Amyotrophique), Agence Générale des Equipements et Produits de Santé
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Jul 2010 (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 study is to study the transporters of serotonin and dopamine in ALS patients in relation with the clinical phenotype, i.e., patients without stiffness, patients with pyramidal stiffness, patients with mixed (pyramidal and extra pyramidal) stiffness.
For such a goal the investigators will use SPECT to compare the binding of two specific tracers in ALS patients and in matched healthy controls.
Detailed description
Study design This study is a prospective cross-sectional controlled multicentric clinical study in 60 ALS patients and 20 controls.
Three cohorts of 20 ALS patients(patients without stiffness, patients with pyramidal stiffness, patients with mixed pyramidal and extra pyramidal stiffness) and 20 healthy controls will be included in this study
Study centres 40 ALS patients and 13 controls will be included in the Paris ALS center, 20 ALS patients and 7 controls will be included in the Tours ALS center.
MRI will be performed at the Neuroradiology department of salpetriere hospital (Paris) and Bretonneau hospital (Tours) SPECT will be done in the nuclear medicine center of each hospital (Paris- Tours).
Study duration Per patient or control, the study will be lasted one month. The total study duration will be two years
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients without stiffness | Other | Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM |
| patients with pyramidal stiffness | Other | Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM |
| patients with mixed stiffness | Other | Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM |
Who may qualify
- Ages
- 39 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients (men or women)
- Patients will be assigned in three groups in relation with the clinical phenotypes:
- Patients have to be capable of thoroughly understanding the information given; have signed the informed consent form (signature of spouse or family relative or acceptable third party is acceptable if the patient is physically unable to sign).
- To have social insurance
Key exclusion criteria (10 listed)
- Patients with a FRONTO temporal dementia (according to NEARY' criteria)
- Patients with any concomitant life-threatening disease or any disease or impairment likely to interfere with functional assessment;
- Patients with any major evolving psychiatric disorder or major anxiety disorder according to DSM-IV criteria (APA, 1996)
- Patients receiving treatments which could interfere with the serotonin or dopamine metabolism
- Patients with contraindications for the dat-scan and /or ADAM scan
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 |
|---|---|---|
| SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAMAlso: PECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM123 I-FP-CIT (DATSCAN) : 185 MBq (5 mCi), 2,5 ml will be injected via an arm intravenous catheter. 123I-ADAM:185 MBq,5 ml will be injected via an arm intravenous catheter. | Drug | patients with mixed stiffness, patients with pyramidal stiffness, patients without stiffness |
Primary outcome
Dopamine transporter binding potential
Time frame: 1 month
2 secondary outcomes
Serotonin transporter binding potential
Time frame: 1 month
Relationships between transporter binding potential and the clinical scores
Time frame: 1 month
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 13 May 2015.
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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.
Lucette Lacomblez, MD principal investigator
Pitié-Salpêtrière Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM in people with Amyotrophic Lateral Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 11 inclusion and 10 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 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. 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 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?
Dopamine transporter binding potential (time frame: 1 month). 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 13 May 2015.