The feasibility of using a subtherapeutic dose of piracetam as a marker of adherence to therapy

Completed

• Conditions: De studie wordt uitgevoerd in gezonde vrijwilligers met als doel te onderzoeken of er een meetbare concentratie piracetam in de urine ontstaat na subtherapeutisch dosering piracetam. Er wordt dus geen effect op een aandoening onderzocht.; n.v.t. (zie uitleg onder vraag C21)

• Registration Number: NL-OMON53199
• Lead Sponsor: ederlands Kanker Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

To be considered eligible to participate in this study, all of the following
requirements must be
met:
1. Age >= 18 years;
2. Able and willing to give written informed consent;
3. Able and willing to undergo urine sampling for analysis;
4. Able and willing to digest multiple tablets at day one of each study week (6
tablets of
1.25 mg in week 1; 4 tablets of 1.25 mg in week 2; 2 tablets of 1.25 mg in week
3 and 1 tablet of 1.25 mg in week 4)

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Current prescribed treatment with piracetam;
2. Pregnant or breastfeeding;
3. Criteria regarding the following contra-indications for piracetam:
- Cerebral haemorrhage;
- Huntington's chorea;
- Hypersensitivity to pyrrolide derivatives.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Verifying the detectability of piracetam in urine after administration of the<br /><br>planned doses using an in-house High-Performance Liquid Chromotography-tandem<br /><br>Mass Spectrometry (HPLC-MS/MS) assay</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the piracetam urine concentrations after nonadherence of two days</p>