Trial record 1 of 1 for:
SPAN-PD
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes (SPAN-PD™)
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| ClinicalTrials.gov Identifier: NCT02240030 |
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Recruitment Status :
Completed
First Posted : September 15, 2014
Results First Posted : April 17, 2018
Last Update Posted : May 28, 2019
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Sponsor:
Acorda Therapeutics
Information provided by (Responsible Party):
Acorda Therapeutics
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Brief Summary:
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.
Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Idiopathic Parkinson's Disease | Drug: CVT-301 Low Dose Drug: CVT-301 High Dose Other: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 351 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official 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™) |
| Study Start Date : | November 2014 |
| Actual Primary Completion Date : | December 2016 |
| Actual Study Completion Date : | December 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
Drug Information available for:
Levodopa
| Arm | Intervention/treatment |
|---|---|
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Experimental: CVT-301 Low Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
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Drug: CVT-301 Low Dose
Other Name: Inhaled levodopa |
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Experimental: CVT-301 High Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
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Drug: CVT-301 High Dose
Other Name: Inhaled levodopa |
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Placebo Comparator: Placebo
Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.
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Other: Placebo
Other Name: Inhalation-grade lactose |
Primary Outcome Measures :
- Unified Parkinson's Disease Rating Scale (UPDRS) Part III [ Time Frame: 30 minutes post-dose at week 12 ]Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
Secondary Outcome Measures :
- Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes. [ Time Frame: at week 12 ]Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed
- UPDRS Part III Motor Score at 20 Minutes [ Time Frame: at week 12 ]Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
- Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12 [ Time Frame: week 12 ]Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better.
- UPDRS Part III at 10 Min. [ Time Frame: week 12 ]Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
- PD Patient Diary [ Time Frame: post week 12 ]Change in total daily OFF times for 3 consecutive days prior to week 12 visit compared to 3 consecutive days prior to baseline visit. Participants recorded On or Off state in 30 minute intervals during waking hours.
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| Ages Eligible for Study: | 30 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240030
Locations
Show 74 study locations
Sponsors and Collaborators
Acorda Therapeutics
Investigators
| Study Director: | Charles Oh, MD | Acorda Therapeutics |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Acorda Therapeutics |
| ClinicalTrials.gov Identifier: | NCT02240030 |
| Other Study ID Numbers: |
CVT-301-004 |
| First Posted: | September 15, 2014 Key Record Dates |
| Results First Posted: | April 17, 2018 |
| Last Update Posted: | May 28, 2019 |
| Last Verified: | May 2019 |
Keywords provided by Acorda Therapeutics:
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Parkinson's Disease Motor fluctuations levodopa inhaled drugs OFF episodes |
Additional relevant MeSH terms:
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies |
Neurodegenerative Diseases Levodopa Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |