Multiple SclerosisPhase 2NCT00342381
Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic Stimulation
A Phase 2 study testing 3,4-diaminopyridine in people with Multiple Sclerosis and Fatigue, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate fatigue in patients with multiple sclerosis (MS) and to determine the correlation between the symptom and cerebral changes. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Fatigue
- What is being tested?
- 3,4-diaminopyridine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2006to Dec 2007
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Relapsing remitting-multiple sclerosis (RR-MS) according to Poser criteria
- EDSS: max 3.5
- Right handed
- Normal function of the right hand
Who cannot join
- Disease interfering with MS
- Known dementia
- Drug or alcohol abuse
- Treatment with psychoactive drugs within one week before study entry
- Major changes of medical treatment within 3 weeks before study entry
- Attack within 4 weeks before study entry
Show all 10Show fewer
- Pregnancy
- Conditions interfering with 3,4-diaminopyridine treatment
- Conditions interfering with MRI
- Conditions interfering with transcranial magnetic stimulation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Neurology
Aarhus, 8000
About this study
Official title: Fatigue in Multiple Sclerosis: Evaluated With 3 Tesla MRI and Transcranial Magnetic Stimulation
The purpose of this study is to investigate fatigue in patients with multiple sclerosis (MS) and to determine the correlation between the symptom and cerebral changes.
Read the detailed description
Only recruiting from:
Department of Neurology, Aarhus University Hospital, Denmark
- Conditions
- Multiple Sclerosis, Fatigue
- Being tested
- 3,4-diaminopyridine, Placebo
- Keywords
- Motor fatigue, Cognitive fatigue
- 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
Single dose 3,4 diaminopyridine
PlaceboDrug
Also called n/d
Single dose placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| 3.4 diaminopyridine | Active comparator | Single dose 3,4 diaminopyridine Receives: Drug: 3,4-diaminopyridine |
| Placebo | Placebo comparator | Two tablets identical to active treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective fatigue (FSS)
Measured: Weeks
Maximal voluntary isometric contraction, central activation before and after exercise
Measured: at the time of investigation
Digit Symbol-Coding scores
Measured: Weeks
Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters)
Measured: at the time of MRI
Cortical atrophy
Measured: at the time of MRI
Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine)
Measured: at the time of investigation
Secondary outcomes (10)
Subjective fatigue (MFI-20, Danish version)
Measured: Weeks
Rapid voluntary twitches
Measured: at the time of investigation
6 minute walk test
Measured: at the time of investigation
9-hole peg test
Measured: at the time of investigation
WAIS/WMS tests
Measured: at the time of investigation
WHO-5 Questionnaire
Measured: at the time of investigation
Major Depression Inventory
Measured: at the time of investigation
Lesion load
Measured: at the time of MRI
Whole brain atrophy
Measured: at the time of MRI
Subjective fatigue (VAS)
Measured: at the time of investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study startJun 2006
- Study completionDec 2007
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 University of AarhusThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Multiple Sclerosis Society
- Investigators
- Henning Andersen, MD, DMSc, Principal investigator, Aarhus University HospitalJohannes Jacobsen, Professor, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342381
- Sponsor's protocol ID
- 20060003
- Status last verified
- Dec 2007
- First submitted
- 20 Jun 2006
- Last updated
- 17 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Multiple Sclerosis: Evaluated With 3 Tesla MRI and Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT00342381
- Acronym / sponsor ID
- 20060003
- Conditions
- Multiple Sclerosis, Fatigue
- Keywords
- Motor fatigue, Cognitive fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Multiple Sclerosis Society
- Study start
- Jun 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Jun 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 study is to investigate fatigue in patients with multiple sclerosis (MS) and to determine the correlation between the symptom and cerebral changes.
Detailed description
Only recruiting from:
Department of Neurology, Aarhus University Hospital, Denmark
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3.4 diaminopyridine | Active comparator | Drug: 3,4-diaminopyridineSingle dose 3,4 diaminopyridine |
| Placebo | Placebo comparator | Drug: PlaceboTwo tablets identical to active treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Relapsing remitting-multiple sclerosis (RR-MS) according to Poser criteria
- EDSS: max 3.5
- Right handed
- Normal function of the right hand
Key exclusion criteria (10 listed)
- Disease interfering with MS
- Known dementia
- Drug or alcohol abuse
- Treatment with psychoactive drugs within one week before study entry
- Major changes of medical treatment within 3 weeks before study entry
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-diaminopyridineSingle dose 3,4 diaminopyridine | Drug | 3.4 diaminopyridine |
| PlaceboAlso: n/dSingle dose placebo treatment | Drug | Placebo |
Primary outcome
Subjective fatigue (FSS)
Time frame: Weeks
Maximal voluntary isometric contraction, central activation before and after exercise
Time frame: at the time of investigation
Digit Symbol-Coding scores
Time frame: Weeks
Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters)
Time frame: at the time of MRI
Cortical atrophy
Time frame: at the time of MRI
Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine)
Time frame: at the time of investigation
10 secondary outcomes
Subjective fatigue (MFI-20, Danish version)
Time frame: Weeks
Rapid voluntary twitches
Time frame: at the time of investigation
6 minute walk test
Time frame: at the time of investigation
9-hole peg test
Time frame: at the time of investigation
WAIS/WMS tests
Time frame: at the time of investigation
WHO-5 Questionnaire
Time frame: at the time of investigation
Major Depression Inventory
Time frame: at the time of investigation
Lesion load
Time frame: at the time of MRI
Whole brain atrophy
Time frame: at the time of MRI
Subjective fatigue (VAS)
Time frame: at the time of investigation
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 17 Dec 2007.
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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.
Henning Andersen, MD, DMSc principal investigator
Aarhus University Hospital
Johannes Jacobsen, Professor study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3,4-diaminopyridine in people with Multiple Sclerosis and Fatigue, run by University of Aarhus at 1 site in Denmark.
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 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 17 Dec 2007. 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 Denmark. 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?
Subjective fatigue (FSS) (time frame: Weeks). The study lists 6 primary outcomes in all. 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 17 Dec 2007.