NCT01385735

Brief Summary

The current study aims to assess the effect of an 8 week Azilect treatment (as adjunct therapy to levodopa) on affect perception and emotional expressiveness in a double-blind placebo-controlled study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_4 parkinson-disease

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_4 parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

June 30, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

June 28, 2011

Last Update Submit

June 29, 2011

Conditions

Parkinson Disease

Keywords

Parkinson DiseaseEmotionmoodexecutive function

Outcome Measures

Primary Outcomes (1)

  • Assess the effect of Azilect on mood, recognition of facial and vocal affect and emotional expressiveness

    * Discrimination Faces * Discrimination Affect * Affect Naming -Faces * Discrimination linguistic prosody * Discrimination affective prosody * Affect naming -congruent and incongruent affective prosody Visual Analogue Scales of emotional expressiveness * Rating by study physician and relative * Self-rating by patient Assessment of executive function * Working Memory (n-back task, digit backward) * Verbal Fluency (Regensburger Wortflüssigkeitstest) Beck Depression Inventary (BDI) Apathie Evaluations-Skala (AES) Social Activity Scale - self assessment PDQ-39- self-assessment

    12 weeks

Secondary Outcomes (1)

  • Effect on motor function in PD

    12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo 1 Tbl per day, 12 week (84 days) duration

Drug: Placebo

Rasagiline

ACTIVE COMPARATOR

Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration

Drug: Rasagiline

Interventions

RasagilineDRUG

Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration

Also known as: Azilect EU/1/04/304/001-007
Rasagiline
PlaceboDRUG

Placebo 1 Tbl per day, 12 week (84 days) duration

Placebo

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • idiopathic PD
  • age range 30-75 yrs, HY I-III
  • stable medication for at least 4 weeks prior to baseline
  • Native speakers (German)
  • signing of informed consent form

You may not qualify if:

  • clinically significant depression (BDI\>13)
  • freezing, pronounced fluctuations
  • other neurological or psychiatric disorders
  • dementia (MMSE\<25)
  • treatment with the MAO-B-inhibitor Selegiline, antidepressants
  • any contraindication according to SmPC
  • participation in another interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Josef Hospital

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Related Publications (5)

  • Roca M, Torralva T, Gleichgerrcht E, Chade A, Arevalo GG, Gershanik O, Manes F. Impairments in social cognition in early medicated and unmedicated Parkinson disease. Cogn Behav Neurol. 2010 Sep;23(3):152-8. doi: 10.1097/WNN.0b013e3181e078de.

    PMID: 20829664BACKGROUND

  • Rosenthal E, Brennan L, Xie S, Hurtig H, Milber J, Weintraub D, Karlawish J, Siderowf A. Association between cognition and function in patients with Parkinson disease with and without dementia. Mov Disord. 2010 Jul 15;25(9):1170-6. doi: 10.1002/mds.23073.

    PMID: 20310053BACKGROUND

  • Scholtissen B, Verhey FR, Adam JJ, Weber W, Leentjens AF. Challenging the serotonergic system in Parkinson disease patients: effects on cognition, mood, and motor performance. Clin Neuropharmacol. 2006 Sep-Oct;29(5):276-85. doi: 10.1097/01.WNF.0000229013.95927.C7.

    PMID: 16960473BACKGROUND

  • Growdon JH, Kieburtz K, McDermott MP, Panisset M, Friedman JH. Levodopa improves motor function without impairing cognition in mild non-demented Parkinson's disease patients. Parkinson Study Group. Neurology. 1998 May;50(5):1327-31. doi: 10.1212/wnl.50.5.1327.

    PMID: 9595982BACKGROUND

  • Timmann D, Daum I. How consistent are cognitive impairments in patients with cerebellar disorders? Behav Neurol. 2010;23(1-2):81-100. doi: 10.3233/BEN-2010-0271.

    PMID: 20714063BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Dirk Woitalla, MD

CONTACT

0049234509dirk.woitalla@rub.de

Anke Hartung

CONTACT

0049234509a.hartung@klinikum-bochum.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 28, 2011

First Posted

June 30, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

April 1, 2013

Last Updated

June 30, 2011

Record last verified: 2011-06

Locations

DE(1)