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NCT Number: NCT02240030

Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes

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.

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Key information

Conditions

IDIOPATHIC PARKINSON'S DISEASE Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Acorda Site #5103, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CVT-301 Low Dose

Drug

Other names: Inhaled levodopa

CVT-301 High Dose

Drug

Other names: Inhaled levodopa

Placebo

Other

Other names: Inhalation-grade lactose

Primary outcomes

  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 outcomes

  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) 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.

  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.

Sponsors and collaborators

Lead sponsor

Acorda Therapeutics

Industry

Registry information

Official study 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™)

Acronym: SPAN-PD™

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2014
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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