Drug Adherence MarkerPhase 4NCT05918341
Subtherapeutic Dose of Piracetam as a Therapy Adherence Marker
A Phase 4 study testing Piracetam in people with Drug Adherence Marker, run by The Netherlands Cancer Institute.
Trial summary
The aim of this study is to test a subtherapeutic dose of piracetam in healthy volunteers as a marker of adherence to therapy to assess the feasibility of its use in a multicentre, randomised, double-blind, placebo-controlled study of the efficacy of dexamphetamine in cocaine dependence (CUD) with comorbid opioid… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Adherence Marker
- What is being tested?
- Piracetam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 3 Jul 2023to 30 Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Able and willing to give written informed consent;
- Able and willing to undergo urine sampling for analysis;
- 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.
Who cannot join
- Current prescribed treatment with piracetam;
- Pregnant or breastfeeding;
- Criteria regarding the following contra-indications for piracetam:
- Cerebral haemorrhage;
- Huntington's chorea;
- Hypersensitivity to pyrrolide derivatives.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Feasibility of Using a Subtherapeutic Dose of Piracetam as a Marker of Adherence to Therapy
The aim of this study is to test a subtherapeutic dose of piracetam in healthy volunteers as a marker of adherence to therapy to assess the feasibility of its use in a multicentre, randomised, double-blind, placebo-controlled study of the efficacy of dexamphetamine in cocaine dependence (CUD) with comorbid opioid addiction (REDUCE study). Several markers for assessing adherence have been described in the literature. However, none of these markers qualified for use within the targeted patient population. Therefore, a suitable adherence marker was sought specifically for the study design of the REDUCE trial. Since within the REDUCE trial urine is submitted biweekly by participants for measuring cocaine use, the adherence marker will also be determined in this matrix. The most suitable marker seems to be piracetam. However, within this study with healthy volunteers, it will first have to be confirmed whether detectable concentrations of piracetam are actually excreted in the urine.
Read the detailed description
This study with healthy volunteers will test a subtherapeutic dose of piracetam as an adherence marker to assess the feasibility of its use in a multicenter, randomized, double-blind, placebo-controlled study of the efficacy of dexamfetamine in cocaine use disorder (CUD) with comorbid opioid use disorder (REDUCE-trial).
Adherence to the study medication in the REDUCE-trial will be assessed by urinanalysis twice weekly for the presence of dexamfetamine. To determine adherence in the placebo group, the tablets must be formulated with a marker detectable in urine. It is necessary to assess adherence in the clinical trial since stimulants will be provided to patients who are dependent on stimulants. Moreover, monitoring adherence ensures that efficacy is established when the medication is taken at the correct dose and frequency.[1] Non-adherence to study medication is especially a problem in trials involving the addicted population, with 10% of participants never taking a dose.[2] In addition, relatively low adherence rates (39-42%) are common for this population.[3][4] Efficacy and safety effects may be underestimated as a result of nonadherence to study medication. Since adherence to placebo was found to be a predictor of better treatment outcomes, it is important to assess this as well.[5]
Several markers for assessing medication adherence are described in the literature.[1][7-12] However, none of these previously used markers were eligible for use within the clinical trial design. First, the measurement of adherence for some markers was based on urine staining (methylene blue, phenol red, fluorescein, phenazopyridine) that would be visible to patients enrolled in the trial. Second, some markers (riboflavin, quinine) are interfered with by dietaryor vitamin intake.[1] In addition, some markers are limited by the occurrence of side effects (phenobarbital).[10][11] Finally, the long half-life of the adherence markers bromide and digoxin would not fit the twice weekly urinalysis, where non-compliance of several days would be masked.[7-9] Therefore, a suitable marker for the clinical trial was searched.
The ideal marker is nontoxic and potentially detectable in urine at a subtherapeutic dose. Therefore, a drug with a relatively high therapeutic dose, high bioavailability, high unchanged renal clearance and low hepatic metabolism is favourable. Thus, detectable amounts in urine at subtherapeutic dose would be likely. Moreover, the half-live of the marker must match the twice weekly assessments of adherence. Of all the authorised drugs in the Netherlands, piracetam was found to meet the most of the criteria. Piracetam is a well-tolerated therapy and registered in the Netherlands for the treatment of vertigo. Daily therapeutic intake is 2400 mg with complete bioavailability, no hepatic metabolism and a renal clearance of about 90%.[13] The likelihood of interference with prescribed piracetam is low, as only 740 patients used the drug in the Netherlands in 2021.[14]
The subtherapeutic dose of piracetam was calculated using the EMA guidelines on shared manufacturing facilities.[15] This guideline contains acceptance limits of cross-contamination between drugs in multipurpose manufacturing processes. These limits are based on the absence of a therapeutic or toxicological effect of the residues of an active drug.[15] The permitted daily exposure (PDE) is calculated using all available pharmacological and toxicological data, including both non-clinical and clinical data, to derive safe thresholds. The PDE represents a substance-specific dose that is unlikely to cause adverse effects if a person is exposed to or below this dose for a lifetime. The PDE for piracetam was calculated to be 8 mg (Appendix I). As patients in the clinical trial receive one, two or three placebo tablets per day, the intention is to add 2.5 mg of piracetam to the placebo tablets. If the urine concentration of piracetam known in the literature at daily intake of 800 mg is extrapolated to 2.5 mg, a measurable urine concentration of 200 ng/ml is expected.[16] However, it should first be confirmed in healthy volunteers whether detectable piracetam concentrations are actually excreted in the urine.
References
- Babalonis S, Hampson AJ, Lofwall MR, Nuzzo PA, Walsh SL. Quinine as a potential tracer for medication adherence: A pharmacokinetic and pharmacodynamic assessment of quinine alone and in combination with oxycodone in humans. J Clin Pharmacol. 2015 Dec;55(12):1332-43. doi: 10.1002/jcph.557. Epub 2015 Jul 29. PMID: 26032168; PMCID: PMC4666817.
- Anderson AL, Li SH, Biswas K, et al. Modafinil for the treatment of methamphetamine dependence. Drug Alcohol Depend. 2012; 120(1-3):135-141. [PubMed: 21840138]
- Swift R, Oslin DW, Alexander M, Forman R. Adherence monitoring in naltrexone pharmacotherapy trials: a systematic review. J Stud Alcohol Drugs. 2011; 72(6):1012-1018. [PubMed: 22051215]
- Weiss RD. Adherence to pharmacotherapy in patients with alcohol and opioid dependence. Addiction. 2004; 99(11):1382-1392. [PubMed: 15500591]
- Granger BB, Swedberg K, Ekman I, et al. Adherence to candesartan and placebo and outcomes in chronic heart failure in the CHAEM prgramme: double-blind, randomized, controlled clinical trial. Lancet. 2005; 366(9502):2005-11. [PubMed: 16338449]
- Ritscher S, Georges C, Wunder C, Wallemacq P, Persu A, Toennes SW. Assessment of adherence to diuretics and β-blockers by serum drug monitoring in comparison to urine analysis. Blood Press. 2020 Oct;29(5):291-298. doi: 10.1080/08037051.2020.1763775. Epub 2020 May 13. PMID: 32400211.
- Braam RL, van Uum SH, Lenders JW, Thien T. Bromide as marker for drug adherence in hypertensive patients. Br J Clin Pharmacol. 2008 May;65(5):733-6. doi: 10.1111/j.1365-2125.2007.03068.x. Epub 2008 Feb 12. PMID: 18279473; PMCID: PMC2432484.
- Braam RL, van Uum SH, Russel FG, Swinkels DW, Thien T. Bromide as a marker to measure adherence to drug therapy. Eur J Clin Pharmacol. 2006 Apr;62(4):285-90. doi: 10.1007/s00228-006-0103-5. Epub 2006 Mar 7. PMID: 16525815.
- Mäenpää H, Javela K, Pikkarainen J, Mälkönen M, Heinonen OP, Manninen V. Minimal doses of digoxin: a new marker for compliance to medication. Eur Heart J. 1987 Oct;8 Suppl I:31-7. doi: 10.1093/eurheartj/8.suppl_i.31. PMID: 3322828.
- Feely M, Cooke J, Price D, Singleton S, Mehta A, Bradford L, Calvert R. Low-dose phenobarbitone as an indicator of compliance with drug therapy. Br J Clin Pharmacol. 1987 Jul;24(1):77-83. doi: 10.1111/j.1365-2125.1987.tb03139.x. PMID: 3113467; PMCID: PMC1386283.
- Wolff K, Hay AA, Raistrick D, Feely M. Use of 'very low-dose phenobarbital' to investigate compliance in patients on reducing doses of methadone (detoxification). J Subst Abuse Treat. 1993 SepOct;10(5):453-8. doi: 10.1016/0740-5472(93)90006-n. PMID: 8246320.
- Herron AJ, Mariani JJ, Pavlicova M, Parrinello CM, Bold KW, Levin FR, Nunes EV, Sullivan MA, Raby WN, Bisaga A. Assessment of riboflavin as a tracer substance: comparison of a qualitative to a quantitative method of riboflavin measurement. Drug Alcohol Depend. 2013 Feb 1;128(1-2):77-82. doi: 10.1016/j.drugalcdep.2012.08.007. Epub 2012 Aug 22. PMID: 22921475; PMCID: PMC3556739.
- KNMP Kennisbank. (2022). Informatorium Medicamentorum (Piracetam). Accessed on 21th of December 2022
- Zorginstituut Nederland (ZIN). GIP databank. 2023. Available: Aantal gebruikers 2017-2021 voor ATC-subgroep N06BX03 : Piracetam | GIPdatabank.nl [Accessed 23 March 2023]
- European Medicine Agency (EMA). EU GMP guide part I: basic requirements for medicinal products: Chapter 3: Shared Manufacturing facilities. 2015. Available: Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (europa.eu) [Accessed 23 March 2023]
- Louchahi K, Tod M, Bonnardel P, Petitjean O. Determination of piracetam in human plasma and urine by liquid chromatography. J Chromatogr B Biomed Appl. 1995 Jan 20;663(2):385-9. doi: 10.1016/0378-4347(94)00448-e. PMID: 7735487.
- College ter Beoordeling Geneesmiddelen (CBG). Geneesmiddeleninformatiebank. 2023. Available: https://www.geneesmiddeleninformatiebank.nl/smpc/h18655_smpc.pdf [Accessed 23 March 2023]
- Conditions
- Drug Adherence Marker
- Being tested
- Piracetam
- Keywords
- Drug adherence, adherence tracer, subtherapeutic dosing, quantitative urinalysis
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiracetamDrug
Subtherapeutic dose of piracetam (once-weekly doses of 7.5 mg, 5 mg, 2.5 mg and 1.25 mg)
| Study group | Role | What they receive |
|---|---|---|
| Piracetam arm (single arm) | Experimental | The single to take once weekly doses of 7.5 mg, 5 mg, 2.5 mg and 1.25 mg piracetam consecutively. Urine was collected 24 and 72 hours after the weekly doses were taken. It was chosen to administer all these doses in each healthy volunteer to account for inter-individual differences in urine concentrations, as these concentrations depend on individual characteristics such as volume intake and renal function. Receives: Drug: Piracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective (detectability of piracetam in urine)
To assess the feasibility of using a subtherapeutic dose of piracetam as a marker of adherence to therapy by determining whether this subtherapeutic dose produces a detectable concentration in the urine.
Measured: 24 hours after weekly ingestion of weekly dosage
Secondary outcomes (1)
Secondary Objective (piracetam concentration after nonadherence)
To determine the piracetam urine concentrations after nonadherence of two days.
Measured: 72 hours after weekly ingestion of weekly dosage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start3 Jul 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Adherence MarkerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single center, open-label, uncontrolled study in 10 healthy volunteers who will receive various subtherapeutic doses of piracetam.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alwin Huitema, Prof. Dr., Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918341
- Sponsor's protocol ID
- N23PIR
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Providing raw participant data to other researchers, for this particular study, will not be of general interest. However, all measured urine concentrations will be published and can be accessed by other researchers in this way.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Using a Subtherapeutic Dose of Piracetam as a Marker of Adherence to Therapy
- ClinicalTrials.gov ID
- NCT05918341
- Acronym / sponsor ID
- N23PIR
- Conditions
- Drug Adherence Marker
- Keywords
- Drug adherence, adherence tracer, subtherapeutic dosing, quantitative urinalysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 3 Jul 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to test a subtherapeutic dose of piracetam in healthy volunteers as a marker of adherence to therapy to assess the feasibility of its use in a multicentre, randomised, double-blind, placebo-controlled study of the efficacy of dexamphetamine in cocaine dependence (CUD) with comorbid opioid addiction (REDUCE study). Several markers for assessing adherence have been described in the literature. However, none of these markers qualified for use within the targeted patient population. Therefore, a suitable adherence marker was sought specifically for the study design of the REDUCE trial. Since within the REDUCE trial urine is submitted biweekly by participants for measuring cocaine use, the adherence marker will also be determined in this matrix. The most suitable marker seems to be piracetam. However, within this study with healthy volunteers, it will first have to be confirmed whether detectable concentrations of piracetam are actually excreted in the urine.
Detailed description
This study with healthy volunteers will test a subtherapeutic dose of piracetam as an adherence marker to assess the feasibility of its use in a multicenter, randomized, double-blind, placebo-controlled study of the efficacy of dexamfetamine in cocaine use disorder (CUD) with comorbid opioid use disorder (REDUCE-trial).
Adherence to the study medication in the REDUCE-trial will be assessed by urinanalysis twice weekly for the presence of dexamfetamine. To determine adherence in the placebo group, the tablets must be formulated with a marker detectable in urine. It is necessary to assess adherence in the clinical trial since stimulants will be provided to patients who are dependent on stimulants. Moreover, monitoring adherence ensures that efficacy is established when the medication is taken at the correct dose and frequency.[1] Non-adherence to study medication is especially a problem in trials involving the addicted population, with 10% of participants never taking a dose.[2] In addition, relatively low adherence rates (39-42%) are common for this population.[3][4] Efficacy and safety effects may be underestimated as a result of nonadherence to study medication. Since adherence to placebo was found to be a predictor of better treatment outcomes, it is important to assess this as well.[5]
Several markers for assessing medication adherence are described in the literature.[1][7-12] However, none of these previously used markers were eligible for use within the clinical trial design. First, the measurement of adherence for some markers was based on urine staining (methylene blue, phenol red, fluorescein, phenazopyridine) that would be visible to patients enrolled in the trial. Second, some markers (riboflavin, quinine) are interfered with by dietaryor vitamin intake.[1] In addition, some markers are limited by the occurrence of side effects (phenobarbital).[10][11] Finally, the long half-life of the adherence markers bromide and digoxin would not fit the twice weekly urinalysis, where non-compliance of several days would be masked.[7-9] Therefore, a suitable marker for the clinical trial was searched.
The ideal marker is nontoxic and potentially detectable in urine at a subtherapeutic dose. Therefore, a drug with a relatively high therapeutic dose, high bioavailability, high unchanged renal clearance and low hepatic metabolism is favourable. Thus, detectable amounts in urine at subtherapeutic dose would be likely. Moreover, the half-live of the marker must match the twice weekly assessments of adherence. Of all the authorised drugs in the Netherlands, piracetam was found to meet the most of the criteria. Piracetam is a well-tolerated therapy and registered in the Netherlands for the treatment of vertigo. Daily therapeutic intake is 2400 mg with complete bioavailability, no hepatic metabolism and a renal clearance of about 90%.[13] The likelihood of interference with prescribed piracetam is low, as only 740 patients used the drug in the Netherlands in 2021.[14]
The subtherapeutic dose of piracetam was calculated using the EMA guidelines on shared manufacturing facilities.[15] This guideline contains acceptance limits of cross-contamination between drugs in multipurpose manufacturing processes. These limits are based on the absence of a therapeutic or toxicological effect of the residues of an active drug.[15] The permitted daily exposure (PDE) is calculated using all available pharmacological and toxicological data, including both non-clinical and clinical data, to derive safe thresholds. The PDE represents a substance-specific dose that is unlikely to cause adverse effects if a person is exposed to or below this dose for a lifetime. The PDE for piracetam was calculated to be 8 mg (Appendix I). As patients in the clinical trial receive one, two or three placebo tablets per day, the intention is to add 2.5 mg of piracetam to the placebo tablets. If the urine concentration of piracetam known in the literature at daily intake of 800 mg is extrapolated to 2.5 mg, a measurable urine concentration of 200 ng/ml is expected.[16] However, it should first be confirmed in healthy volunteers whether detectable piracetam concentrations are actually excreted in the urine.
References
- Babalonis S, Hampson AJ, Lofwall MR, Nuzzo PA, Walsh SL. Quinine as a potential tracer for medication adherence: A pharmacokinetic and pharmacodynamic assessment of quinine alone and in combination with oxycodone in humans. J Clin Pharmacol. 2015 Dec;55(12):1332-43. doi: 10.1002/jcph.557. Epub 2015 Jul 29. PMID: 26032168; PMCID: PMC4666817.
- Anderson AL, Li SH, Biswas K, et al. Modafinil for the treatment of methamphetamine dependence. Drug Alcohol Depend. 2012; 120(1-3):135-141. [PubMed: 21840138]
- Swift R, Oslin DW, Alexander M, Forman R. Adherence monitoring in naltrexone pharmacotherapy trials: a systematic review. J Stud Alcohol Drugs. 2011; 72(6):1012-1018. [PubMed: 22051215]
- Weiss RD. Adherence to pharmacotherapy in patients with alcohol and opioid dependence. Addiction. 2004; 99(11):1382-1392. [PubMed: 15500591]
- Granger BB, Swedberg K, Ekman I, et al. Adherence to candesartan and placebo and outcomes in chronic heart failure in the CHAEM prgramme: double-blind, randomized, controlled clinical trial. Lancet. 2005; 366(9502):2005-11. [PubMed: 16338449]
- Ritscher S, Georges C, Wunder C, Wallemacq P, Persu A, Toennes SW. Assessment of adherence to diuretics and β-blockers by serum drug monitoring in comparison to urine analysis. Blood Press. 2020 Oct;29(5):291-298. doi: 10.1080/08037051.2020.1763775. Epub 2020 May 13. PMID: 32400211.
- Braam RL, van Uum SH, Lenders JW, Thien T. Bromide as marker for drug adherence in hypertensive patients. Br J Clin Pharmacol. 2008 May;65(5):733-6. doi: 10.1111/j.1365-2125.2007.03068.x. Epub 2008 Feb 12. PMID: 18279473; PMCID: PMC2432484.
- Braam RL, van Uum SH, Russel FG, Swinkels DW, Thien T. Bromide as a marker to measure adherence to drug therapy. Eur J Clin Pharmacol. 2006 Apr;62(4):285-90. doi: 10.1007/s00228-006-0103-5. Epub 2006 Mar 7. PMID: 16525815.
- Mäenpää H, Javela K, Pikkarainen J, Mälkönen M, Heinonen OP, Manninen V. Minimal doses of digoxin: a new marker for compliance to medication. Eur Heart J. 1987 Oct;8 Suppl I:31-7. doi: 10.1093/eurheartj/8.suppl_i.31. PMID: 3322828.
- Feely M, Cooke J, Price D, Singleton S, Mehta A, Bradford L, Calvert R. Low-dose phenobarbitone as an indicator of compliance with drug therapy. Br J Clin Pharmacol. 1987 Jul;24(1):77-83. doi: 10.1111/j.1365-2125.1987.tb03139.x. PMID: 3113467; PMCID: PMC1386283.
- Wolff K, Hay AA, Raistrick D, Feely M. Use of 'very low-dose phenobarbital' to investigate compliance in patients on reducing doses of methadone (detoxification). J Subst Abuse Treat. 1993 SepOct;10(5):453-8. doi: 10.1016/0740-5472(93)90006-n. PMID: 8246320.
- Herron AJ, Mariani JJ, Pavlicova M, Parrinello CM, Bold KW, Levin FR, Nunes EV, Sullivan MA, Raby WN, Bisaga A. Assessment of riboflavin as a tracer substance: comparison of a qualitative to a quantitative method of riboflavin measurement. Drug Alcohol Depend. 2013 Feb 1;128(1-2):77-82. doi: 10.1016/j.drugalcdep.2012.08.007. Epub 2012 Aug 22. PMID: 22921475; PMCID: PMC3556739.
- KNMP Kennisbank. (2022). Informatorium Medicamentorum (Piracetam). Accessed on 21th of December 2022
- Zorginstituut Nederland (ZIN). GIP databank. 2023. Available: Aantal gebruikers 2017-2021 voor ATC-subgroep N06BX03 : Piracetam | GIPdatabank.nl [Accessed 23 March 2023]
- European Medicine Agency (EMA). EU GMP guide part I: basic requirements for medicinal products: Chapter 3: Shared Manufacturing facilities. 2015. Available: Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (europa.eu) [Accessed 23 March 2023]
- Louchahi K, Tod M, Bonnardel P, Petitjean O. Determination of piracetam in human plasma and urine by liquid chromatography. J Chromatogr B Biomed Appl. 1995 Jan 20;663(2):385-9. doi: 10.1016/0378-4347(94)00448-e. PMID: 7735487.
- College ter Beoordeling Geneesmiddelen (CBG). Geneesmiddeleninformatiebank. 2023. Available: https://www.geneesmiddeleninformatiebank.nl/smpc/h18655_smpc.pdf [Accessed 23 March 2023]
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single center, open-label, uncontrolled study in 10 healthy volunteers who will receive various subtherapeutic doses of piracetam.
| Arm | Type | Receives |
|---|---|---|
| Piracetam arm (single arm) | Experimental | Drug: PiracetamThe single to take once weekly doses of 7.5 mg, 5 mg, 2.5 mg and 1.25 mg piracetam consecutively. Urine was collected 24 and 72 hours after the weekly doses were taken. It was chosen to administer all these doses in each healthy volunteer to account for inter-individual differences in urine concentrations, as these concentrations depend on individual characteristics such as volume intake and renal function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Able and willing to give written informed consent;
- Able and willing to undergo urine sampling for analysis;
- 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.
Key exclusion criteria (6 listed)
- Current prescribed treatment with piracetam;
- Pregnant or breastfeeding;
- Criteria regarding the following contra-indications for piracetam:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiracetamSubtherapeutic dose of piracetam (once-weekly doses of 7.5 mg, 5 mg, 2.5 mg and 1.25 mg) | Drug | Piracetam arm (single arm) |
Primary outcome
Primary Objective (detectability of piracetam in urine)
Time frame: 24 hours after weekly ingestion of weekly dosage
To assess the feasibility of using a subtherapeutic dose of piracetam as a marker of adherence to therapy by determining whether this subtherapeutic dose produces a detectable concentration in the urine.
1 secondary outcome
Secondary Objective (piracetam concentration after nonadherence)
Time frame: 72 hours after weekly ingestion of weekly dosage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: No. Providing raw participant data to other researchers, for this particular study, will not be of general interest. However, all measured urine concentrations will be published and can be accessed by other researchers in this way.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alwin Huitema, Prof. Dr. principal investigator
The Netherlands Cancer Institute
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Piracetam in people with Drug Adherence Marker, run by The Netherlands Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anke Leeuwerik, MSc (0031624321167, a.leeuwerik@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (detectability of piracetam in urine) (time frame: 24 hours after weekly ingestion of weekly dosage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.