D-serine Adjuvant Treatment for Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

D-serine Adjuvant Treatment for Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215904
• Other study ID #: Heresco1CTIL
• Secondary ID: 20030312
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2005
• Last updated: July 5, 2012
• Start date: August 2003
• Est. completion date: May 2008

Study information

• Verified date: July 2012
• Source: Herzog Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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).

Locations

Country	Name	City	State
Israel	Ezrath Nashim - Herzog Memorial Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Herzog Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPDRS scores		6 weeks	No
Primary	PANSS scores		6 weeks	No