Text Size

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
History of Changes

September 18, 2005
July 5, 2012
August 2003
May 2008   (final data collection date for primary outcome measure)
  • UPDRS scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • PANSS scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00215904 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
D-serine Adjuvant Treatment for Parkinson's Disease
D-serine Adjuvant Treatment for Parkinson's Disease

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Parkinson's Disease
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
    Intervention: Drug: D-serine (~2g/day)
  • Experimental: 2
    Intervention: Drug: D-serine (~2g/day)
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. Epub 2011 Jul 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00215904
Heresco1CTIL, 20030312
Yes
Heresco-Levi Uriel, Herzog Hospital
Herzog Hospital
Not Provided
Principal Investigator: Uriel Heresco-Levy Ezrath Nashim - Herzog Memorial Hospital
Herzog Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP