A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s disease
- Conditions
- Parkinson's DiseaseMedDRA version: 15.1Level: LLTClassification code 10034007Term: Parkinson's disease NOSSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-005822-31-IT
- Lead Sponsor
- Civitas Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
In order to be eligible to enter the study, patients must meet all of the following criteria:
1.Has signed and dated an IRB/IEC-approved informed consent form before any protocol-specific screening procedures are performed.
2.Has a clinical diagnosis of idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the UK Brain Bank criteria, diagnosed after the age of 30 years.
3.Is a male or female aged 30 to 80 years, inclusive. Women of child-bearing potential must use protocol-defined contraceptive measures (see Section 11.1.5) and must have a negative serum human chorionic gonadotropin (hCG) test at screening. These patients must be willing to remain on their current form of contraception for the duration of the study.
4.Is classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
5.Is LD-responsive (as documented by the investigator) with a PD medication regimen that includes a LD/DDI-containing regimen at least 4 times during the waking day. LD-containing regimens must be stable for at least 2 weeks prior to screening.
6.Has normal cognition as confirmed by a score of =25 on the Mini Mental State Examination (MMSE).
7.Has a difference in UPDRS Part 3 scores of =25% between ON and OFF states during screening.
8.If treated with dopamine agonists, COMT inhibitors, MAO-B inhibitors, or other non-LD-containing PD medications, must be on a stable dose for at least 4 weeks prior to screening and must remain stable throughout the study.
9.Has not received apomorphine for at least 4 weeks prior to screening and agrees not to be treated with apomorphine for the duration of the study.
10.Experiences motor fluctuations with recognizable and predictable OFF episodes and has an average of at least 2 hours of OFF time per waking day, exclusive of early morning OFF time (by self-report and confirmed by diary). Patients should be able to recognize their wearing off” symptoms and verify that they usually improve after their next dose of PD medication.
11.Is willing and able to complete all study assessments and procedures.
12.If a current smoker, is able to comply with the following guidelines: agrees not to smoke for the entire clinic visit days (including screening visits, in-clinic treatment visits, and follow-up visit) until completion of all study procedures.
13.If the patient is a current or former smoker, has no history of, nor has ever been treated for any smoking-related pulmonary condition (e.g., chronic bronchitis, emphysema, chronic obstructive pulmonary disease [COPD]) or asthma, and has no evidence of obstructive lung disease by spirometry assessment. Patient must agree to abstain from smoking on the day of each in-clinic visit from waking through completion of all assessments for that visit day.
14.Has a screening FEV1 greater than 60% of predicted for race, age, sex, and height, and FEV1/FVC ratio greater than or equal to 75%, in the ON state.
15.If taking anti-depressant medication, the anti-depressant dose must be stable for at least 4 weeks prior to screening.
16.Understands (with or without caregiver assistance) his/her daily PD medications.
17.Is able (with or without caregiver assistance) to attend all study visits.
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Nu
Patients meeting any of the following exclusion criteria at screening will not be enrolled in the study:
1.Is a pregnant or lactating woman.
2.Has dyskinesia of a severity that might significantly interfere with the patient’s ability to perform study procedures and assessments.
3.Has a current history of symptomatic orthostatic hypotension despite adequate treatment.
4.Has any known contraindication to the use of LD, including a history of malignant melanoma or a history of narrow-angle glaucoma.
5.Has any condition that in the investigator’s opinion would make the patient unsuitable for participation in the study and/or medical condition that, in the opinion of the investigator, would interfere with participation in this study.
6.Has a history of COPD, asthma, or other chronic respiratory diseases within the last 5 years, or is currently receiving treatment for any of these conditions.
7.Has any contraindication to performing routine spirometry (see Appendix 12 for a list of contraindications).
8.Has used reserpine or catecholaminergic blocking agents within the last 3 months.
9.Has a history of psychotic symptoms requiring treatment with an antipsychotic medication within the past 12 months; however, in regions where they are approved, certain low-dose atypical antipsychotic agents (which may be prescribed for conditions other than psychosis) are allowed if the dose has been stable for at least 8 weeks prior to screening (quetiapine =50 mg/day, risperidone =1 mg/day, and olanzipine =2.5 mg/day).
10.Has received dopamine agonist blocking agents and/or non-specific monoamine oxidase inhibitors (MAOIs) within the last 3 months; however, in regions where it is approved, use of domperidone is permitted if the maximum daily dose does not exceed 60 mg and if the dose has been stable for at least 4 weeks prior to screening.
11.Has a history of suicidal ideation or suicide attempt within the past 12 months.
12.Has had previous stereotactic surgery or is planning surgery during the study period.
13.In the opinion of the investigator (or caregiver, as applicable), has signs/symptoms suggestive of clinically significant cognitive impairment that would interfere with the ability to comply with study procedures.
14.Has a history of any primary malignancy, with the exception of basal cell or successfully treated squamous cell carcinomas of the skin, cervical carcinoma in situ, or prostatic carcinoma in situ; or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.
15.Has a history within 12 months prior to screening of substance-related disorders (with the exception of caffeine-related and nicotine-related disorders) as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR).
16.Has any clinically significant abnormality following review of screening laboratory data, previous medical history or intercurrent illness, and physical examination data that, in the investigator’s opinion, may compromise the safety of the patient in the study.
17.Has been treated with an investigational drug within 4 weeks or 5 half-lives (whichever is longer) prior to the beginning of the screening period (this includes investigational formulations of marketed products).
18.Has had any prior exposure to CVT-301.
Note: An active or recent (within 3 days) respiratory infection will not disqualify a patient from enrolling in the study. However, all symptoms should be resolved for
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method