Relapsing-Remitting Multiple SclerosisPhase 2NCT00917839
The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
A Phase 2 study testing lamotrigine in people with Relapsing-Remitting Multiple Sclerosis, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
This study is designed to evaluate the neuroprotective effect of lamotrigine in the combination of interferon beta 1a once weekly intramuscular in patients with relapsing-remitting multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- lamotrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2009to Dec 2011
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- definitive multiple sclerosis according to Mc Donald criteria
- clinical isolated syndrome according to Mc Donald criteria
- Expanded Disability Status Scale Score 0-5
- Pre-treatment with interferon beta 1a (Avonex) since at least 2 months before inclusion
Who cannot join
- relapse within 30 days prior to randomisation
- steroid pulse therapy within 30 days prior to randomisation
- pregnancy or poor contraception
- contraindication for lamotrigine
- depressive symptoms
- drugs with possible interaction with lamotrigine according to instruction leaflet
Show all 10Show fewer
- other medical relevant conditions but multiple sclerosis
- clinically relevant laboratory results
- contraindication for MRI
- missing informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Norman Putzki, MD, +4171494 ext. 1663, norman.putzki@kssg.ch
Norman Putzki, MD
About this study
Official title: Randomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis.
This study is designed to evaluate the neuroprotective effect of lamotrigine in the combination of interferon beta 1a once weekly intramuscular in patients with relapsing-remitting multiple sclerosis.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- lamotrigine
- Keywords
- neuroprotection, multiple sclerosis, brain atrophy, mr-spectroscopy
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lamotrigineDrug
100 mg, once daily, 12 months
| Study group | Role | What they receive |
|---|---|---|
| lamotrigine | Experimental | 7 weeks initial phase with increasing dose beginning with 25 mg oral 12 months treatment phase with fixed dose of 100 mg oral Receives: Drug: lamotrigine |
| Placebo | Placebo comparator | 300mg Mannitol with 2% Aerosil Receives: Drug: lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
Measured: 12 months
Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.
Measured: 6 months, 12 months
Secondary outcomes (4)
relapse rate
Measured: 12 months
Expanded disability status score
Measured: 12 months
Fatigue Severity Score
Measured: 12 months
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-Remitting Multiple 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
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917839
- Sponsor's protocol ID
- LT.01
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2009
- Last updated
- 10 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT00917839
- Acronym / sponsor ID
- LT.01
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- neuroprotection, multiple sclerosis, brain atrophy, mr-spectroscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 10 Jun 2009 (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.
This study is designed to evaluate the neuroprotective effect of lamotrigine in the combination of interferon beta 1a once weekly intramuscular in patients with relapsing-remitting multiple sclerosis.
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 |
|---|---|---|
| lamotrigine | Experimental | Drug: lamotrigine7 weeks initial phase with increasing dose beginning with 25 mg oral 12 months treatment phase with fixed dose of 100 mg oral |
| Placebo | Placebo comparator | Drug: lamotrigine300mg Mannitol with 2% Aerosil |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- definitive multiple sclerosis according to Mc Donald criteria
- clinical isolated syndrome according to Mc Donald criteria
- Expanded Disability Status Scale Score 0-5
- Pre-treatment with interferon beta 1a (Avonex) since at least 2 months before inclusion
Key exclusion criteria (10 listed)
- relapse within 30 days prior to randomisation
- steroid pulse therapy within 30 days prior to randomisation
- pregnancy or poor contraception
- contraindication for lamotrigine
- depressive symptoms
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 |
|---|---|---|
| lamotrigine100 mg, once daily, 12 months | Drug | Placebo, lamotrigine |
Primary outcome
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
Time frame: 12 months
Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.
Time frame: 6 months, 12 months
4 secondary outcomes
relapse rate
Time frame: 12 months
Expanded disability status score
Time frame: 12 months
Fatigue Severity Score
Time frame: 12 months
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 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.
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 lamotrigine in people with Relapsing-Remitting Multiple Sclerosis, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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: status not confirmed, as of the sponsor's last update on 10 Jun 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norman Putzki, MD (+4171494 ext. 1663, norman.putzki@kssg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy (time frame: 12 months). The study lists 2 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 10 Jun 2009.