|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02240030 |
|
Date of registration:
|
11/09/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
SPAN-PD™ |
|
Scientific title:
|
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™) |
|
Date of first enrolment:
|
November 2014 |
|
Target sample size:
|
351 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02240030 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Canada
|
Czech Republic
|
Czechia
|
Poland
|
Spain
|
United States
| | |
|
Contacts
|
|
Name:
|
Charles Oh, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Acorda Therapeutics |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 years;
- Hoehn and Yahr Stage 1-3 in an "on" state;
- Require levodopa-containing medication regimen at least 3 times during the waking day;
- Experience motor fluctuations with a minimum of 2 hours of average daily "off" time
per waking day (excluding early morning "off" time) and demonstrate levodopa
responsiveness;
- Are on stable PD medication regimen;
- Total daily LD dose <1600 mg/day;
- Able to perform a spirometry maneuver in the ON and OFF states;
- Normal cognition confirmed by MMSE score =25
Exclusion Criteria:
- Pregnant or lactating females;
- Previous surgery for PD or plan to have stereotactic surgery during the study period;
- History of psychotic symptoms requiring treatment, or suicide ideation or attempt
within last year;
- Known contraindication to the use of levodopa;
- Any significant condition, severe concurrent disease, abnormality or finding that
would make patients unsuitable or may compromise patient safety;
- Any contraindication to performing routine spirometry.
Age minimum:
30 Years
Age maximum:
85 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Idiopathic Parkinson's Disease
|
|
Intervention(s)
|
|
Other: Placebo
|
|
Drug: CVT-301 High Dose
|
|
Drug: CVT-301 Low Dose
|
|
Primary Outcome(s)
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Part III
[Time Frame: 30 minutes post-dose at week 12]
|
|
Secondary Outcome(s)
|
|
UPDRS Part III Motor Score at 20 Minutes
[Time Frame: at week 12]
|
|
PD Patient Diary
[Time Frame: post week 12]
|
|
UPDRS Part III at 10 Min.
[Time Frame: week 12]
|
|
Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.
[Time Frame: at week 12]
|
|
Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12
[Time Frame: week 12]
|
|
Secondary ID(s)
|
|
CVT-301-004
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|