Multiple SclerosisPhase 3NCT00190268
Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis
A Phase 3 study testing 3,4-diaminopyridine in people with Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in patient's multiple sclerosis. In order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded study is performed. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- 3,4-diaminopyridine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 4 sitesFrance
- Study dates
- Feb 2005to Jun 2008
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age >= 18 years and = <60 years
- Patients with multiple sclerosis clinically defined and with MIFS-SEP score > 44, without deficit sleep and without depression.
- Patients without treatment by 3,4-DAP since 3 months
- EDSS score < 6
Who cannot join
- ASAT/ALAT > 2 x ULN
- MADRS >= 20
- Abnormality cardiac rhythm
- Pregnancy
- Asthma
- Evolutive affection
- Renal failure
Trial locations and contacts
4 sites in 1 country.
France4 sites
Henri Mondor Hospital
Créteil, 94010
Pitié Salpetriere Hospital
Paris, 75013
Tenon Hospital
Paris, 75020
Pontchaillou Hospital
Rennes, 35000
About this study
Official title: Multicentric Study, Comparative, Randomized, in Double Knowledge of the Effectiveness (Versus Placebo) of a Salt Of 3,4 - Diaminopyridine in the Treatment of Tiredness During the Multiple Sclerosis
Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in patient's multiple sclerosis.
In order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded study is performed.
Read the detailed description
We proposed a randomized controlled trial between 3,4-diaminopyridine and placebo .
The main objective : improvement of fatigue by diminution of EMIF-SEP score between the arm treatment and placebo arm. The hypothesis tested is that the 3,4-DAP is efficacy in the fatigue of multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- 3,4-diaminopyridine
- Keywords
- multiple sclerosis, fatigue, 3,4-diaminopyridine
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3,4-diaminopyridineDrug
3,4-diaminopyridine
| Study group | Role | What they receive |
|---|---|---|
| 3,4-diaminopyridine | Experimental | 3,4-diaminopyridine Receives: Drug: 3,4-diaminopyridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
Measured: 43 months
Secondary outcomes (2)
evaluation of safety
evaluation of safety
Measured: 43 months
quality of life impact
quality of life impact
Measured: 43 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Pierre Cesaro, MD, Study chair, Hopital Henri Mondor-France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190268
- Sponsor's protocol ID
- P020304
- Status last verified
- Mar 2007
- First submitted
- 13 Sep 2005
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study, Comparative, Randomized, in Double Knowledge of the Effectiveness (Versus Placebo) of a Salt Of 3,4 - Diaminopyridine in the Treatment of Tiredness During the Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00190268
- Acronym / sponsor ID
- P020304
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, fatigue, 3,4-diaminopyridine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 19 Sep 2005 (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.
Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in patient's multiple sclerosis.
In order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded study is performed.
Detailed description
We proposed a randomized controlled trial between 3,4-diaminopyridine and placebo .
The main objective : improvement of fatigue by diminution of EMIF-SEP score between the arm treatment and placebo arm. The hypothesis tested is that the 3,4-DAP is efficacy in the fatigue of multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3,4-diaminopyridine | Experimental | Drug: 3,4-diaminopyridine3,4-diaminopyridine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age >= 18 years and = <60 years
- Patients with multiple sclerosis clinically defined and with MIFS-SEP score > 44, without deficit sleep and without depression.
- Patients without treatment by 3,4-DAP since 3 months
- EDSS score < 6
Key exclusion criteria (7 listed)
- ASAT/ALAT > 2 x ULN
- MADRS >= 20
- Abnormality cardiac rhythm
- Pregnancy
- Asthma
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 |
|---|---|---|
| 3,4-diaminopyridine3,4-diaminopyridine | Drug | 3,4-diaminopyridine |
Primary outcome
improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
Time frame: 43 months
improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
2 secondary outcomes
evaluation of safety
Time frame: 43 months
quality of life impact
Time frame: 43 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 21 Feb 2011.
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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.
Pierre Cesaro, MD study chair
Hopital Henri Mondor-France
4 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 3,4-diaminopyridine in people with Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 4 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 4 inclusion and 7 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 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group. (time frame: 43 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 21 Feb 2011.