We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

D-serine Adjuvant Treatment for Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00215904
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 9, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: D-serine (~2g/day) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: D-serine Adjuvant Treatment for Parkinson's Disease
Study Start Date : August 2003
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Serine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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).


Outcome Measures

Primary Outcome Measures :
  1. UPDRS scores [ Time Frame: 6 weeks ]
  2. PANSS scores [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215904


Locations
Israel
Ezrath Nashim - Herzog Memorial Hospital
Jerusalem, Israel, 91351
Sponsors and Collaborators
Herzog Hospital
Investigators
Principal Investigator: Uriel Heresco-Levy Ezrath Nashim - Herzog Memorial Hospital
More Information

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
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases