A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson's Disease Patients with OFF episodes
- Conditions
- Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)MedDRA version: 19.0Level: LLTClassification code 10034007Term: Parkinson's disease NOSSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-005626-19-ES
- Lead Sponsor
- Civitas Therapeutics, a wholly owned subsidiary of Acorda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 440
Inclusion Criteria (not assessed for the CVT-301-004 study
patients):
? Has signed and dated an IRB/IEC-approved informed
consent form before any protocol-specific screening
procedures are performed.
? Is a male or female aged 30 to 86 years, inclusive. Women
of child-bearing potential must use protocol-defined
contraceptive measures 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.
? Patients who have idiopathic PD (i.e., not induced by drugs
or other diseases) as defined by fulfilling Steps 1 and 2 of
the United Kingdom (UK) Brain Bank criteria, diagnosed
after the age of 30 years.
? Patients who are classified as Stage 1 to 3 (in the ON state)
on the modified Hoehn and Yahr scale for staging of PD
severity.
? Patients who have experienced motor fluctuations for a
minimum of 2 hours of average daily OFF time per waking
day (excluding early morning OFF time) by self-report and
confirmed by the PD Diary (on 3 consecutive days) during
the screening period.
? Patients who are on a LD-containing therapy, not including
Rytary (or equivalent), must be stable on oral LD-containing
therapy for at least 2 weeks prior to SV1 with a
LD/dopamine decarboxylase inhibitor (DDI)-containing
regimen.
? Patients who are on a LD-containing therapy, when
including Rytary (or equivalent), should be on a stable dose
for at least 6 weeks prior to SV1
? The frequency of L-dopa administrations must be at least 3
times during the waking day and a total daily LD dose of ?
1600 mg
? Patients should be stable on other PD medications for at
least 4 weeks prior to SV1.
? Patients must have a ?25% difference between UPDRS Part
3 scores recorded in their ON and OFF states at screening.
? Patients must have normal cognition as confirmed by a score
of ?25 on the MMSE (in the ON state).
? Patients must be able to perform a spirometry maneuver in
the ON and OFF states and must have a screening FEV1 ?
50% of predicted, and an FEV1/FVC ratio > 60% in the ON
state at screening. (A pulmonologist will review the
spirometry tracings/morphology of any patients with an
FEV1 that is ? 50% to < 60% of predicted or an FEV1/FVC
ratio that is >60% to <70% in order to determine eligibility.
Patients with an FEV1/FVC ratio that is >60% to <70% will
complete spirometry before and after the administration of a
bronchodilator in a pulmonary function laboratory. Testing
will be performed in accordance with the 2005
ATS/European Respiratory Society [ERS] criteria prior to
randomization. The results of the bronchodilator challenge
will be reviewed by a pulmonologist prior to potential
randomization.)
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 317
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 123
? Patients who have dyskinesia of a severity that would
significantly interfere with their ability to participate or
perform study procedures.
? Pregnant or lactating females or females wishing to become
pregnant.
? Patients who have any known contraindication to the use of
LD, including a history of malignant melanoma or a history
of narrow-angle glaucoma.
? Patients who have had previous surgery for PD (including
but not limited to cell transplantation) or plan to have
stereotactic surgery during the study period. Patients who
have had deep brain stimulation [DBS] will also be excluded
unless the procedure was performed more than 6 months
prior to study enrollment.
? Patients with a history of psychotic symptoms requiring
treatment, or suicidal ideation or attempt within the prior
12 months.
? Patients who have cancer with the exception of the
following: basal cell carcinoma or successfully treated
squamous cell carcinoma of the skin; cervical carcinoma in
situ; prostatic carcinoma in situ; or other malignancies
curatively treated and with no evidence of disease recurrence
for at least 3 years.
? Patients taking certain prohibited medications.
? Patients with a history of drug or alcohol abuse within the
prior 12 months.
? Patients with chronic obstructive pulmonary disease
(COPD), asthma, or other chronic respiratory disease within
the last 5 years
? Patients with any contraindication to performing routine
spirometry or who are unable to perform a spirometry
maneuver.
? Patients with a current history of symptomatic orthostatic
hypotension despite adequate treatment.
? Patients with any condition that in the investigator?s opinion
would make patients unable to comply with study procedures or make them unsuitable for their participation in the study.
? Patients who have any clinically significant abnormality or
finding from examination, tests, or history that may
compromise patient safety. Potential issues of concern
should be raised to the medical monitor during eligibility
review.
? For new CVT-301 naïve patients, patients who have been
treated with an investigational drug within 4 weeks or 5 halflives (whichever is longer) prior to the beginning of the
screening period (this includes investigational formulations
of marketed products).
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