D-serine Adjuvant Treatment for Parkinson's Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: D-serine (~2g/day) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) |
| Official Title: | D-serine Adjuvant Treatment for Parkinson's Disease |
- UPDRS scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- PANSS scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 13 |
| Study Start Date: | August 2003 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: 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).
|
| Experimental: 2 |
Drug: 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).
|
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- PD diagnosis
- ≥2 on UPDRS items 32,33
- receive treatment with L-dopa alone or in combination with other antiparkinsonian medications.
Exclusion Criteria:
- current or previous history of other neurological disorders
- unstable medical conditions
- renal pathology
- pregnant female patients excluded
Contacts and Locations| Israel | |
| Ezrath Nashim - Herzog Memorial Hospital | |
| Jerusalem, Israel, 91351 | |
| Principal Investigator: | Uriel Heresco-Levy | Ezrath Nashim - Herzog Memorial Hospital |
More Information
No publications provided by Herzog Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Heresco-Levi Uriel, Princepal Investigator, Herzog Hospital |
| ClinicalTrials.gov Identifier: | NCT00215904 History of Changes |
| Other Study ID Numbers: | Heresco1CTIL, 20030312 |
| Study First Received: | September 18, 2005 |
| Last Updated: | July 5, 2012 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Movement Disorders Neurodegenerative Diseases Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013