D-serine Adjuvant Treatment for Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heresco-Levi Uriel, Herzog Hospital
ClinicalTrials.gov Identifier:
NCT00215904
First received: September 18, 2005
Last updated: July 5, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by Herzog Hospital:

Primary Outcome Measures:
  • 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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 30, 2014