DyslexiaPhase 4NCT00111371
Dopaminergic Enhancement of Learning and Memory in Healthy Adults and Patients With Dyslexia
A Phase 4 study testing Levodopa in people with Dyslexia, run by University Hospital Muenster at 1 site in Germany.
Trial summary
This study aims to determine whether levodopa, in combination with a high frequency training of (grammatical) rules, is effective in boosting learning success in healthy subjects and whether this kind of training in combination with levodopa improves reading and spelling abilities of patients with dyslexia. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslexia
- What is being tested?
- Levodopa
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Oct 2015
- Phase
- Phase 4
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handedness
- Age between 18-35 years
- Primary language: German
Who cannot join
- Known allergy to levodopa or tetrazine
- History of medication/drug abuse
- Acute nicotine withdrawal or > 10 cigarettes per day
- >6 cups/glasses of coffee, caffeine drinks or energy drinks per day
- >50 grams of alcohol per day
- Hypertonia
Show all 11Show fewer
- Arteriosclerosis
- Diabetes, asthma, or glaucoma
- Psychiatric disease
- Neurologic disease
- Other medication
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Neurology, University Hospital of Muenster
Münster, North Rhine-Westphalia, 48129
Stefan Knecht, Prof. Dr., +49-251-83 ext. 48195, knecht@uni-muenster.de
Stefan Knecht, M.D.
About this study
Official title: Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Dyslexia)
This study aims to determine whether levodopa, in combination with a high frequency training of (grammatical) rules, is effective in boosting learning success in healthy subjects and whether this kind of training in combination with levodopa improves reading and spelling abilities of patients with dyslexia.
Read the detailed description
Prior work by our group shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind trial, we probe whether daily administration of levodopa, coupled with a training of grammatical rules, improves the training success in healthy adults as compared to placebo administration. In the second step of this study, patients with dyslexia will be trained with the identical protocol. We postulate that the combination of intensive training in language rules and levodopa improves the reading, writing, and spelling abilities of patients with dyslexia.
- Conditions
- Dyslexia
- Being tested
- Levodopa
- Keywords
- artificial grammar learning, dyslexia, healthy subjects, levodopa, drug, treatment, intervention
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevodopaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Boost in training success (percent correct) through levodopa as compared to placebo
Boost in training success (reaction times) through levodopa as compared to placebo
Increased performance on reading, spelling and writing tests in dyslexic patients treated with levodopa as compared to placebo
Secondary outcomes (1)
Stability of improvements one month post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2005 (estimated)
- Study startJan 2005
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DyslexiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Knecht, Prof. Dr., Principal investigator, Dept. of Neurology, Universityclinic of Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111371
- Sponsor's protocol ID
- LL-001; Project on Dyslexia
- Status last verified
- Sep 2006
- First submitted
- 19 May 2005
- Last updated
- 5 Dec 2014
- Results posted
- No
Publications
Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Floel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6. doi: 10.1002/ana.20125.
PubMed 15236398Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. doi: 10.1007/s00115-002-1466-1. German.
PubMed 12596014Opitz B, Friederici AD. Brain correlates of language learning: the neuronal dissociation of rule-based versus similarity-based learning. J Neurosci. 2004 Sep 29;24(39):8436-40. doi: 10.1523/JNEUROSCI.2220-04.2004.
PubMed 15456816
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Dyslexia)
- ClinicalTrials.gov ID
- NCT00111371
- Acronym / sponsor ID
- LL-001; Project on Dyslexia
- Conditions
- Dyslexia
- Keywords
- artificial grammar learning, dyslexia, healthy subjects, levodopa, drug, treatment, intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Oct 2015 (estimated)
- First posted
- 20 May 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.
This study aims to determine whether levodopa, in combination with a high frequency training of (grammatical) rules, is effective in boosting learning success in healthy subjects and whether this kind of training in combination with levodopa improves reading and spelling abilities of patients with dyslexia.
Detailed description
Prior work by our group shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind trial, we probe whether daily administration of levodopa, coupled with a training of grammatical rules, improves the training success in healthy adults as compared to placebo administration. In the second step of this study, patients with dyslexia will be trained with the identical protocol. We postulate that the combination of intensive training in language rules and levodopa improves the reading, writing, and spelling abilities of patients with dyslexia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Right-handedness
- Age between 18-35 years
- Primary language: German
Key exclusion criteria (11 listed)
- Known allergy to levodopa or tetrazine
- History of medication/drug abuse
- Acute nicotine withdrawal or > 10 cigarettes per day
- >6 cups/glasses of coffee, caffeine drinks or energy drinks per day
- >50 grams of alcohol per day
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 |
|---|---|---|
| Levodopa | Drug | – |
Primary outcome
Boost in training success (percent correct) through levodopa as compared to placebo
Boost in training success (reaction times) through levodopa as compared to placebo
Increased performance on reading, spelling and writing tests in dyslexic patients treated with levodopa as compared to placebo
1 secondary outcome
Stability of improvements one month post training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Background: PubMed 15236398Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Floel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6. doi: 10.1002/ana.20125.
- Background: PubMed 12596014Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. doi: 10.1007/s00115-002-1466-1. German.
- Background: PubMed 15456816Opitz B, Friederici AD. Brain correlates of language learning: the neuronal dissociation of rule-based versus similarity-based learning. J Neurosci. 2004 Sep 29;24(39):8436-40. doi: 10.1523/JNEUROSCI.2220-04.2004.
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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.
Stefan Knecht, Prof. Dr. principal investigator
Dept. of Neurology, Universityclinic of Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levodopa in people with Dyslexia, run by University Hospital Muenster at 1 site in Germany.
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 3 inclusion and 11 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 5 Dec 2014. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Stefan Knecht, MD (+49-251-83 ext. 48195, knecht@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boost in training success (percent correct) through levodopa as compared to placebo. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00111371, which also lists 3 linked publications.
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 5 Dec 2014.