The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00917839

Enrollment

Registered

2009-06-10

Start date

2009-06-30

Completion date

2011-12-31

Last updated

2009-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

neuroprotection, multiple sclerosis, brain atrophy, mr-spectroscopy

Brief 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.

Interventions

DRUGlamotrigine

100 mg, once daily, 12 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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 * other medical relevant conditions but multiple sclerosis * clinically relevant laboratory results * contraindication for MRI * missing informed consent

Design outcomes

Primary

Measure	Time frame
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy	12 months
Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.	6 months, 12 months

Secondary

Measure	Time frame
relapse rate	12 months
Expanded disability status score	12 months
Fatigue Severity Score	12 months
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy	6 months

Countries

Switzerland

Contacts

Primary ContactNorman Putzki, MD

norman.putzki@kssg.ch+4171494

Backup ContactOzgur Yaldizli, MD

oezguer.yaldizli@kssg.ch+4171494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026