Passiflora Extract for Benzodiazepine Withdrawal | NCT03780595

Studies
Passiflora Extract for Benzodiazepine Withdrawal

NCT03780595

Sponsor

Nutricion Medica S.L.

Status

Unknown status

Last Update Posted

Dec 19, 2018Actual

Enrollment

108Estimated

Phase

Phase 4

Conditions

Benzodiazepine Withdrawal (Disorder)

Interventions

Passiflora incarnata
Control

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 27, 2018Actual

Primary Completion Date

Jun 30, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Dec 18, 2018

First Submission Date that Met QC Criteria

Dec 18, 2018

First Posted Date

Dec 19, 2018Actual

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

Dec 18, 2018

Last Update Posted Date

Dec 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this clinical trials is compare the percentage of patient who achieve a reduction equal to or greater than 50% in the dose of benzodiazepines at 10 weeks of treatment.

Detailed Description

Not provided

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

108Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Passiflora	Experimental		Drug: Passiflora incarnata
Control	Placebo Comparator		Drug: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Passiflora incarnata	Drug	Passiflora pills administration up to 6 pills per day	Passiflora

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% Reduction of the benzodiazepine dose		10 weeks of treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 65 years old
Stable dose of benzodiazepines during last 3 months ( 4mg loracepam per day or equivalent)
Capable of giving consent and to answer the questionnaires according to researcher criteria

Exclusion Criteria:

Diagnosis of dementia moderate or severe (Test Minimental ≤ 20).
Acute confusional syndrome at the inclusion
Panic disorder
Obsesive-compulsive disorder
Any type of psycosis or bipolar disorder
Severe Parkison disease diagnosed
Current or past diagnosis of epilepsia
Recent stroke (last month)
Thyroid disorders not controlled or uncompensated
Alteration of deglutition
Previous drugs or alcohol abuse
Hospitalization (more than 24 hours) during the last month
Complex priority treatment (dialisis, chemotherapy...)
Life expectation less than 1 year
Benzodiazepines therapeutic uses not for anxiety or insomnio

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
María de Andres	Contact	+34 913 14 92 71		mariade.andres@nutricionmedica.com

Overall Officials

Name	Affiliation	Role
Luis Fernando Agüera	Hospital Universitario 12 de Octubre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Residencia Albertia Moratalaz	Recruiting	Madrid			Spain