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Trial record 11 of 53 for:    acorda

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
Recruitment Status : Completed
First Posted : September 15, 2014
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

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

Drug Information available for: Levodopa
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CVT-301 Low Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
Drug: CVT-301 Low Dose
Other Name: Inhaled levodopa
Experimental: CVT-301 High Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
Drug: CVT-301 High Dose
Other Name: Inhaled levodopa
Placebo Comparator: Placebo
Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.
Other: Placebo
Other Name: Inhalation-grade lactose



Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.

  3. 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.

  4. 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.

  5. 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, Senior)
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


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Sponsors and Collaborators
Acorda Therapeutics
Investigators
Study Director: Charles Oh, MD Acorda Therapeutics

Additional Information:
Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02240030     History of Changes
Other Study ID Numbers: CVT-301-004
First Posted: September 15, 2014    Key Record Dates
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018
Last Verified: February 2018

Keywords provided by Acorda Therapeutics:
Parkinson's Disease
Motor fluctuations
levodopa
inhaled drugs
OFF episodes

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs