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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-005022-10 | EudraCT Number |
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The study has been terminated prematurely due to recruitment difficulties. Current status: recruitment stopped and cleaning of the database is ongoing.
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The project is targeting cognitive impairment, one of the main health problems of patients with RAS pathway disorders. The aim of this study is to translate findings of animal studies to humans. This has been done by the applicants successfully for Lovastatin in Nf1. This result will be transferred to patients with Noonan Syndrome. lamotrigine is most likely a more effective and promising substance improving synaptic plasticity and consecutive cognitive function. It is expected that both substances are improving synaptic plasticity as well as alertness and changes in alertness may be a precondition for improvement of cognition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exp. I: Noonan Syndrome - Lovastatin | Experimental | 200 mg Lovastatin daily for four days / Lovastatin-placebo (cross-over) prior to transcranial magnetic stimulation and test of attentional performance |
|
| Exp. II: Noonan Syndrome - Lamotrigine | Experimental | 300 mg Lamotrigine single dose / Lamotrigine-placebo prior to transcranial magnetic stimulation and test of attentional performance |
|
| Exp. III: Neurofibromatosis Type 1 - Lamotrigine | Experimental | 300 mg Lamotrigine single dose / Lamotrigine-placebo prior to transcranial magnetic stimulation and test of attentional performance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lovastatin | Drug | oral application prior to transcranial magnetic stimulation intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term potentiation (LTP)-like plasticity measured with transcranial magnetic stimulation (TMS) | Changes in peak-to-peak amplitudes of motor evoked potentials (MEP) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the neuropsychological testing of attention (Test of attentional performance) after placebo and after medication (LTG and LOV) | Response time (seconds) for alertness, visual scanning, Go/no Go, Incompatibility | 12 months |
| Differences in short interval cortical inhibition (SICI) after placebo and after medication (LTG and LOV) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of safety: EMG recording during TMS evaluation | Safety | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technical University Munich | Munich | 81377 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24088225 | Background | Mainberger F, Jung NH, Zenker M, Wahllander U, Freudenberg L, Langer S, Berweck S, Winkler T, Straube A, Heinen F, Granstrom S, Mautner VF, Lidzba K, Mall V. Lovastatin improves impaired synaptic plasticity and phasic alertness in patients with neurofibromatosis type 1. BMC Neurol. 2013 Oct 2;13:131. doi: 10.1186/1471-2377-13-131. | |
| 37280688 |
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| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D009456 | Neurofibromatosis 1 |
| D009634 | Noonan Syndrome |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D017253 | Neurofibromatoses |
| D009455 | Neurofibroma |
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| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Monocenter, randomized, double-blind, parallel-group, placebo controlled, cross-over design with a series of three experiments (Noonan Syndrome: 2 experiments; Neurofibromatosis type 1 1 experiment) and n=14 participants per experiments
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| Lamotrigine | Drug | oral application prior to transcranial magnetic stimulation intervention |
|
Changes in SICI |
| 12 months |
| Jung NH, Egert-Schwender S, Schossow B, Kehl V, Wahllander U, Brich L, Janke V, Blankenstein C, Zenker M, Mall V. Improvement of synaptic plasticity and cognitive function in RASopathies-a monocentre, randomized, double-blind, parallel-group, placebo-controlled, cross-over clinical trial (SynCoRAS). Trials. 2023 Jun 6;24(1):383. doi: 10.1186/s13063-023-07392-z. |
| D018317 |
| Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |