Parkinson's Disease, IdiopathicPhase 1NCT00507715
Study of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk
A Phase 1 study testing Plantago ovata husk and hemicellulose crystalline in people with Parkinson's Disease, Idiopathic, run by Rottapharm Spain at 1 site in Spain.
Trial summary
The purpose of this trial is to study the effect of the association levodopa/carbidopa with plantago ovata husk in Parkinson´s disease patients of recent diagnostic, that are being treated with levodopa/carbidopa. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Parkinson's Disease, Idiopathic
- What is being tested?
- Plantago ovata husk and hemicellulose crystalline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2006to Nov 2006
- Phase
- Phase 1
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnostic of idiopathic Parkinson disease, with well controlled symptomatology with administration of l-dopa/carbidopa.
- At least 3 months of treatment continued of levodopa.
- Patients that give the their consent to participate in the study.
Who cannot join
- Patients with diagnostic of idiopathic Parkinson disease, with bad controlled symptomatology with administration of l-dopa/carbidopa.
- Patients with allergic predisposition to Plantago ovata husk or other contraindications for its use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Study the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk
The purpose of this trial is to study the effect of the association levodopa/carbidopa with plantago ovata husk in Parkinson´s disease patients of recent diagnostic, that are being treated with levodopa/carbidopa.
Read the detailed description
Although the treatment with l-dopa is the election treatment for Parkinson´s disease, a high number of patients develop motor complications, including, fluctuations and dyscinesia after some years of treatment.
The origin of the fluctuations is not well established, but it could be attributed, al least partially, a pharmacokinetics factors. So that, it could improve the answer and reduce the adverse reaction if we reach more stable levels of L-dopa in the circulation. The first experimental studies in animals showed that Plantago ovata husk has an influence in the pharmacokinetics parameters of L-dopa, obtaining more stable levels.
- Conditions
- Parkinson's Disease, Idiopathic
- Being tested
- Plantago ovata husk, hemicellulose crystalline
- Keywords
- Parkinson's Disease, Idiopathic, l-dopa levels, plantago ovata husk
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plantago ovata huskDrug
5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days
hemicellulose crystallineOther
5g effervescent powder t.id. during 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Plantago ovata husk Receives: Drug: Plantago ovata husk |
| 2 | Placebo comparator | hemicellulose crystalline Receives: Other: hemicellulose crystalline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study how the fiber Plantago ovata husk modifies the pharmacokinetics parameters of the absorption and elimination of L-dopa.
Measured: 14 days
Secondary outcomes (1)
To evaluate if the treatment with Plantago ovata husk modifies the biochemical parameters as total cholesterol, HDL y LDL, glycaemia, etc.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startSep 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease, IdiopathicStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rottapharm Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sierra Matilde, Ph, phD, Study chair, Departamento de Ciencias Biomédicas de la Facultad de Veterinaria de la Universidad de León, León (Spain)Carriedo Demetrio, MD, Principal investigator, Hospital de León, León (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507715
- Sponsor's protocol ID
- PLAN-EC-LDOPA-FI
- Other IDs
- EudraCT number:2006-000491-33
- Status last verified
- Jul 2007
- First submitted
- 25 Jul 2007
- Last updated
- 26 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Study the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk
- ClinicalTrials.gov ID
- NCT00507715
- Acronym / sponsor ID
- PLAN-EC-LDOPA-FI
- Conditions
- Parkinson's Disease, Idiopathic
- Keywords
- Parkinson's Disease, Idiopathic, l-dopa levels, plantago ovata husk
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rottapharm SpainIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 26 Jul 2007 (estimated)
- 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 purpose of this trial is to study the effect of the association levodopa/carbidopa with plantago ovata husk in Parkinson´s disease patients of recent diagnostic, that are being treated with levodopa/carbidopa.
Detailed description
Although the treatment with l-dopa is the election treatment for Parkinson´s disease, a high number of patients develop motor complications, including, fluctuations and dyscinesia after some years of treatment.
The origin of the fluctuations is not well established, but it could be attributed, al least partially, a pharmacokinetics factors. So that, it could improve the answer and reduce the adverse reaction if we reach more stable levels of L-dopa in the circulation. The first experimental studies in animals showed that Plantago ovata husk has an influence in the pharmacokinetics parameters of L-dopa, obtaining more stable levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Plantago ovata huskPlantago ovata husk |
| 2 | Placebo comparator | Other: hemicellulose crystallinehemicellulose crystalline |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with diagnostic of idiopathic Parkinson disease, with well controlled symptomatology with administration of l-dopa/carbidopa.
- At least 3 months of treatment continued of levodopa.
- Patients that give the their consent to participate in the study.
Key exclusion criteria (2 listed)
- Patients with diagnostic of idiopathic Parkinson disease, with bad controlled symptomatology with administration of l-dopa/carbidopa.
- Patients with allergic predisposition to Plantago ovata husk or other contraindications for its use.
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 |
|---|---|---|
| Plantago ovata husk5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days | Drug | 1 |
| hemicellulose crystalline5g effervescent powder t.id. during 14 days | Other | 2 |
Primary outcome
To study how the fiber Plantago ovata husk modifies the pharmacokinetics parameters of the absorption and elimination of L-dopa.
Time frame: 14 days
1 secondary outcome
To evaluate if the treatment with Plantago ovata husk modifies the biochemical parameters as total cholesterol, HDL y LDL, glycaemia, etc.
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2007.
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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.
Sierra Matilde, Ph, phD study chair
Departamento de Ciencias Biomédicas de la Facultad de Veterinaria de la Universidad de León, León (Spain)
Carriedo Demetrio, MD principal investigator
Hospital de León, León (Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Plantago ovata husk and hemicellulose crystalline in people with Parkinson's Disease, Idiopathic, run by Rottapharm Spain at 1 site in Spain.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 26 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study how the fiber Plantago ovata husk modifies the pharmacokinetics parameters of the absorption and elimination of L-dopa. (time frame: 14 days). 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 Jul 2007; AzTrials last refreshed its copy on 8 Nov 2026.