NCT01617135

Brief Summary

The purpose of this study is to determine the safety, efficacy and pharmacokinetics following administration of CVT-301 in treatment of "off" episodes in Parkinson's Disease patients.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2012

Shorter than P25 for phase_2

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

May 7, 2012

Last Update Submit

July 25, 2017

Conditions

Idiopathic Parkinson's Disease

Keywords

Parkinson's diseaseMotor fluctuationslevodopainhaled drugsMotor fluctuation ("off episodes")

Outcome Measures

Primary Outcomes (1)

  • Safety

    Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function

    change from baseline up to 13 weeks

Secondary Outcomes (2)

  • Pharmacodynamics

    3 hours post-dose

  • Pharmacokinetics

    3 hours post-dose

Study Arms (4)

CVT-301 Low Dose

EXPERIMENTAL

CVT-Low; levodopa inhalation powder (LIP)

Drug: CVT-301

CVT-301 High Dose

EXPERIMENTAL

CVT-High; levodopa inhalation powder (LIP)

Drug: CVT-301

Inhaled Placebo

PLACEBO COMPARATOR

Inhaled placebo powder

Drug: Placebo

Oral Sinemet (carbidopa/levodopa)

ACTIVE COMPARATOR

Open-label oral carbidopa/levodopa (CD/LD)

Drug: Sinemet (carbidopa/levodopa)

Interventions

CVT-301DRUG
CVT-301 Low Dose
PlaceboDRUG
Inhaled Placebo
Sinemet (carbidopa/levodopa)DRUG
Oral Sinemet (carbidopa/levodopa)

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;
  • Hoehn and Yahr Stage 1-3 in an "on" state;
  • Require levodopa-containing medication regimen at least 4 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.

You may not qualify if:

  • 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;
  • Adequate lung function as measured by spirometry;
  • Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Civitas Clinical Site #6

Petah Tikva, Israel

Location

Civitas Clinical Site #5

Tel Aviv, Israel

Location

Civitas Clinical Site #4

Belgrade, Serbia

Location

Civitas Clinical Site #7

Belgrade, Serbia

Location

Civitas Clinical Site #1

Glasgow, United Kingdom

Location

Civitas Clinical Site #3

Newcastle, United Kingdom

Location

Civitas Clinical Site #2

Norwich, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combinationCarbidopaLevodopa

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

MethyldopaDihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsHydrazinesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2012

First Posted

June 12, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations

GB(3)IL(2)SE(2)