D-serine Adjuvant Treatment for Parkinson's Disease

July 5, 2012 updated by: Heresco-Levi Uriel, Herzog Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91351
        • Ezrath Nashim - Herzog Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
UPDRS scores
Time Frame: 6 weeks
6 weeks
PANSS scores
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herzog Hospital

Investigators

  • Principal Investigator: Uriel Heresco-Levy, Ezrath Nashim - Herzog Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 18, 2005

First Submitted That Met QC Criteria

September 18, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 9, 2012

Last Update Submitted That Met QC Criteria

July 5, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Heresco1CTIL
  • 20030312

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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