D-serine Adjuvant Treatment for Parkinson's Disease
2 other identifiers
interventional
13
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2003
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 18, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedJuly 9, 2012
July 1, 2012
4.8 years
September 18, 2005
July 5, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
UPDRS scores
6 weeks
PANSS scores
6 weeks
Study Arms (2)
1
PLACEBO COMPARATOR2
EXPERIMENTALInterventions
Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine (\~2g/day). Second arm : adjuvant treatment with placebo (\~2g/day).
Eligibility Criteria
You may qualify if:
- PD diagnosis
- ≥2 on UPDRS items 32,33
- receive treatment with L-dopa alone or in combination with other antiparkinsonian medications.
You may not qualify if:
- current or previous history of other neurological disorders
- unstable medical conditions
- renal pathology
- pregnant female patients excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herzog Hospitallead
Study Sites (1)
Ezrath Nashim - Herzog Memorial Hospital
Jerusalem, 91351, Israel
Related Publications (1)
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.
PMID: 21733283DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Uriel Heresco-Levy
Ezrath Nashim - Herzog Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Princepal Investigator
Study Record Dates
First Submitted
September 18, 2005
First Posted
September 22, 2005
Study Start
August 1, 2003
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
July 9, 2012
Record last verified: 2012-07