A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study

• Conditions: Parkinson 's Disease early stage; MedDRA version: 8.1Level: LLTClassification code 10013113Term: Disease Parkinson's

• Registration Number: EUCTR2006-000678-57-DE
• Lead Sponsor: Solvay pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

1. Subjects who provide written informed consent before starting any study specific procedures.
2. The clinical diagnosis of subjects must meet the criteria for Diagnosis of idiopathic Parkinson’s Disease according to the modified UKPDS Brain Bank criteria (see Appendix 16.3).
3. Modified Hoehn and Yahr up to stage 3.
4. Unified Parkinson’s Disease Rating Scale motor score (part 3) must have a total of at least 10 at baseline.
5. Out patients.
6. Subjects of = 30 years old.
7. For anti-PD medication other than SLV308 and pramipexole, the following criteria apply:
- Subjects may have had treatment with L-dopa formulations or dopamine agonists up to a total of 90 days.
- Subjects must have stopped the use of L-dopa and/or dopamine agonists for at least 90 days prior to baseline.
- Efficacious previous treatment is not allowed to be stopped for the sole purpose of enrolling the subject into this study.
- Concurrent anti-PD treatment other than L-dopa and dopamine agonists (i.e., selegiline, rasagiline, anti-cholinergics, amantadine) is allowed if the doses have been kept stable for at least 28 days prior to baseline and during the study.
8. Male and female, females must be of non-childbearing potential or:
- have a negative serum ß-human chorionic gonadotropin, and
- use an accepted form of contraception (a stable dose of contraceptive drug for at least three months or barrier methods: intra-uterine device, diaphragm, combination of a condom and spermicide).
Non-childbearing potential is defined as being post-menopausal for at least 24 months prior to Visit 1, or surgically sterilized (i.e., tubal ligation or hysterectomy).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Related to Parkinson’s Disease
1. Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists, such as secondary parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes (e.g., multiple system atrophy, progressive supranuclear palsy) or heredodegenerative diseases.
2. Subjects who have undergone surgery for the treatment of PD (e.g., pallidotomy, deep brain stimulation, fetal tissue transplantation) or have undergone any other brain surgery.
3. Presence of dyskinesias, motor fluctuations or loss of postural reflexes.
4. Subjects with a history of non-response (according to both the clinician and the subject) to an adequate course of L-dopa or a dopamine agonist.
5. Subjects for whom previous treatment with dopamine agonists needed to be terminated because of the induction of psychosis (e.g. hallucinations) and/or sleep attacks.
6. Treatment within 60 days prior to baseline with monoamine oxidase (MAO) inhibitors (other than selegiline and rasagiline), alpha-methyldopa or metoclopramide; treatment within last 30 days before baseline with parenteral ergots, methylphenidate, amphetamine, beta-blockers for treating tremor, isoprenaline, adrenaline, dopamine, dobutamide, reserpine, flunarizine or cinnarizine. (See also Section 7.8.2).
Related to Psychiatric and Neurological Disorders
7. Current diagnosis or history of drug or alcohol abuse (Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV criteria), within 12 months prior to Visit 1.
8. Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, such as bipolar disorder or major depressive disorder (DSM-IV criteria).
9. Subjects who, based on history and mental status examination, are considered to be violent (likely to harm themselves or others), or subjects considered at suicidal risk by the investigator.
10. Other psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the study. Cognitive impairment (Mini Mental State Examination [MMSE] = 24), dementia or significant concomitant neurological disease would also be included under this category.
11. A history of hallucinations, psychosis and/or treatment with antipsychotics within a year from baseline.
12. A history of, or current, seizure disorders (other than febrile seizures in childhood) and subjects requiring treatment with anti-convulsants, whatever the indication.
13. Subjects known with serious symptomatic cerebral disease, cerebrovascular disease, focal neurological lesions (previous brain surgery), or any acute brain trauma requiring treatment with anticonvulsant therapy.
Related to Other Medical Conditions
14. Clinically significant abnormal laboratory data at Visit 1 or any abnormal laboratory value that could interfere with the assessment of safety or efficacy.
15. Current evidence of clinically significant hematological, autoimmune, endocrine, cardiovascular, renal or gastrointestinal disorder that would possibly interfere with the subject’s participation in the study (e.g., treated, controlled and thus stable hypertension is not considered an exclusion criterion).
16. Subjects whose current regimen of medication or condition suggests that it will not remain constant for the duration of study participation will be excluded from the trial.
17. Known unstable insulin dependent diabetes mellitus (treatment control: glycosylated hemoglobi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified