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SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE) (SYNAPSE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02258152
First Posted: October 7, 2014
Last Update Posted: August 3, 2017
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.
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
Parkinson's Study Group
Massachusetts General Hospital
Acorda Therapeutics
Information provided by (Responsible Party):
Biotie Therapies Inc.
October 3, 2014
October 7, 2014
August 3, 2017
December 22, 2014
December 2017   (Final data collection date for primary outcome measure)
Change in Cognitive Drug Research Computerized Cognition Battery (CDR) Continuity of Attention from baseline [ Time Frame: Week 16 ]
Same as current
Complete list of historical versions of study NCT02258152 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
The purpose of this study placebo-controlled, randomized, double-blind study is to assess the safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already treated with a stable dose of a cholinesterase inhibitor.

This study includes a Screening Period of up to 6 weeks, a 16 week Treatment Period, and a 2 week Safety Follow Up Period.

Final eligibility will be determined at the Baseline Visit. Eligible patients will be randomized to receive placebo or SYN120 100 mg once a day (QD).

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Parkinson's Disease Dementia (PDD)
  • Drug: SYN120
    SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).
  • Drug: Placebo
    Placebo QD
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: SYN120
    Intervention: Drug: SYN120
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2017
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Parkinson's Disease Dementia
  • Patient has a routine caregiver
  • Taking a stable cholinesterase inhibitor.
  • Patient has a Montreal Cognitive Assessment (MoCA) 10-23 inclusive

Exclusion Criteria:

  • History of any significant neurologic or psychiatric disease other than PD
  • Any other condition or clinically significant abnormal findings that would make the patient unsuitable for the study
  • Unpredictable motor fluctuations that would interfere with administering assessments
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02258152
SYN120-CL03
Yes
Not Provided
Not Provided
Biotie Therapies Inc.
Biotie Therapies Inc.
  • Michael J. Fox Foundation for Parkinson's Research
  • Parkinson's Study Group
  • Massachusetts General Hospital
  • Acorda Therapeutics
Not Provided
Biotie Therapies Inc.
August 2017

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