Evaluation of the Efficacy of Rasagiline in Apathy in Dru... | NCT01765257

ID	Type	Description	Link
2007-002800-16

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Mar 2015Estimated

First Submitted Date

Jan 8, 2013

First Submission Date that Met QC Criteria

Jan 9, 2013

First Posted Date

Jan 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2013

Last Update Posted Date

Jan 10, 2013Estimated

Name	Class
H. Lundbeck A/S	INDUSTRY
CHU Purpan (Toulouse)	UNKNOWN
Hôpital Haut-Lévêque	OTHER
Centre Hospitalier de la côte Basque

Description Module

Brief Summary

Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum.

Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease.

The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.

Detailed Description

Study design :

Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France

Population :

50 drug-naïve patients with Parkinson's disease, with apathy. 2 groups : 25 patients with placebo and 25 patients with rasagiline.

3 visits

Visit 1 : inclusion / randomisation/ first study medication dispensation
Visit 2 (1.5 month after V1) : first evaluation and second study medication dispensation.
Visit 3 (3 months after V1, final visit) : second evaluation

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rasagiline	Experimental	Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France	Drug: AZILECT®
placebo	Placebo Comparator	Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZILECT®	Drug		rasagiline
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lille Apathy Rating Scale (LARS) score		at the visit 3 (after 3 months of treatment)

Secondary Outcomes

Measure	Description	Time Frame
Motor assessment : Unified Parkinson's Disease Rating Scale		at the visit 3 (after 3 months of treatment)
Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale		at the visit 3 (after 3 months of treatment)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Drug-naïve patients with Parkinson's disease (UKPDBB criteria)

No dementia (Mattis dementia rating scale > 130; Mini Mental Sate Examination ≥26)
No depression (MADRS < 15)
Criteria of apathy from Robert et al (2009)
At least mild apathy (≥-21 to Lille Apathy Rating Scale)
Age : 35-70 y
Affiliation to social security
Agreement of patients

Exclusion Criteria:

- Any antiparkinsonian treatment (L.dopa, dopamine agonists, MAO-B-I, amantadine, anticholinergics). Patients treated by dopamine agonists but who have stopped it more than 3 months before their inclusion can be included.
Ongoing severe psychiatric or somatic diseases
Others treatments :
antipsychotics
antidepressants and anxiolytics (exclusion if the treatment is not stable the month before inclusion)
psychostimulants (methylphenidate, adrafinil, modafinil, deanol, vitamin C, sulbutiamine, glutamic acid, aspartic acid)
any contra-indication according to SmPC
patients under guardianship
Women without efficient contraception
Person who participate to an other study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick LACARIN	Contact	04 73 75 11 95		placarin@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Denis PEZET	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand		Clermont-Ferrand		63003	France

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms