Parkinson's DiseasePhase 4NCT00215904
D-serine Adjuvant Treatment for Parkinson's Disease
A Phase 4 study testing D-serine (~2g/day) in people with Parkinson's Disease, run by Herzog Hospital at 1 site in Israel.
Trial summary
The proposed experiment will evaluate the effects of the NMDA receptor full agonist D-serine (~2g/day) on persistent symptoms of Parkinson's Disease and on antiparkinsonian drugs-induced dyskinesias. D-serine will be used as add-on therapy to on-going medications received by Parkinson's Disease patients. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- D-serine (~2g/day)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2003to May 2008
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PD diagnosis
- ≥2 on UPDRS items 32,33
- receive treatment with L-dopa alone or in combination with other antiparkinsonian medications.
Who cannot join
- current or previous history of other neurological disorders
- unstable medical conditions
- renal pathology
- pregnant female patients excluded
Trial locations and contacts
1 site in 1 country.
About this study
The proposed experiment will evaluate the effects of the NMDA receptor full agonist D-serine (~2g/day) on persistent symptoms of Parkinson's Disease and on antiparkinsonian drugs-induced dyskinesias.
D-serine will be used as add-on therapy to on-going medications received by Parkinson's Disease patients. The rational for this study stems from observations made in pervious clinical trials with schizophrenia patients, in which it was demonstrated that D-serine adjuvant treatment resulted in:1)improvement of parkinsonian side effects induced by antipsychotic drugs and 2) improvement of depression and negative (i.e apathy, blunted effects, anhedonia) symptoms which are similar to symptoms encountered in Parkinson's Disease.
The study will have a crossover design in accordance to which each patient will receive, in random order D-serine and placebo for a 6 weeks period each. Thus, any participant will have the opportunity to receive the experimental treatment.
- Conditions
- Parkinson's Disease
- Being tested
- D-serine (~2g/day)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-serine (~2g/day)Drug
Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine (~2g/day). Second arm : adjuvant treatment with placebo (~2g/day).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: D-serine (~2g/day) |
| 2 | Experimental | Not described Receives: Drug: D-serine (~2g/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS scores
Measured: 6 weeks
PANSS scores
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herzog Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heresco-Levi Uriel, Herzog Hospital
- Investigators
- Uriel Heresco-Levy, Principal investigator, Ezrath Nashim - Herzog Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215904
- Sponsor's protocol ID
- Heresco1CTIL
- Other IDs
- 20030312
- Status last verified
- Jul 2012
- First submitted
- 18 Sep 2005
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gelfin E, Kaufman Y, Korn-Lubetzki I, Bloch B, Kremer I, Javitt DC, Heresco-Levy U. D-serine adjuvant treatment alleviates behavioural and motor symptoms in Parkinson's disease. Int J Neuropsychopharmacol. 2012 May;15(4):543-9. doi: 10.1017/S1461145711001015. Epub 2011 Jul 7.
PubMed 21733283
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-serine Adjuvant Treatment for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00215904
- Acronym / sponsor ID
- Heresco1CTIL
- Conditions
- Parkinson's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Herzog HospitalUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 22 Sep 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.
The proposed experiment will evaluate the effects of the NMDA receptor full agonist D-serine (~2g/day) on persistent symptoms of Parkinson's Disease and on antiparkinsonian drugs-induced dyskinesias.
D-serine will be used as add-on therapy to on-going medications received by Parkinson's Disease patients. The rational for this study stems from observations made in pervious clinical trials with schizophrenia patients, in which it was demonstrated that D-serine adjuvant treatment resulted in:1)improvement of parkinsonian side effects induced by antipsychotic drugs and 2) improvement of depression and negative (i.e apathy, blunted effects, anhedonia) symptoms which are similar to symptoms encountered in Parkinson's Disease.
The study will have a crossover design in accordance to which each patient will receive, in random order D-serine and placebo for a 6 weeks period each. Thus, any participant will have the opportunity to receive the experimental treatment.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: D-serine (~2g/day) |
| 2 | Experimental | Drug: D-serine (~2g/day) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PD diagnosis
- ≥2 on UPDRS items 32,33
- receive treatment with L-dopa alone or in combination with other antiparkinsonian medications.
Key exclusion criteria (4 listed)
- current or previous history of other neurological disorders
- unstable medical conditions
- renal pathology
- pregnant female patients excluded
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 |
|---|---|---|
| D-serine (~2g/day)Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine (~2g/day). Second arm : adjuvant treatment with placebo (~2g/day). | Drug | 1, 2 |
Primary outcome
UPDRS scores
Time frame: 6 weeks
PANSS scores
Time frame: 6 weeks
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 9 Jul 2012.
- Derived from this study: PubMed 21733283Gelfin E, Kaufman Y, Korn-Lubetzki I, Bloch B, Kremer I, Javitt DC, Heresco-Levy U. D-serine adjuvant treatment alleviates behavioural and motor symptoms in Parkinson's disease. Int J Neuropsychopharmacol. 2012 May;15(4):543-9. doi: 10.1017/S1461145711001015. Epub 2011 Jul 7.
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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.
Uriel Heresco-Levy principal investigator
Ezrath Nashim - Herzog Memorial Hospital
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 D-serine (~2g/day) in people with Parkinson's Disease, run by Herzog Hospital at 1 site in Israel.
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 4 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 9 Jul 2012. 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 Israel. 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 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?
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?
UPDRS scores (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT00215904, which also lists 1 linked publication.
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 9 Jul 2012.