Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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7 June 2021 |
Main ID: |
NCT03436953 |
Date of registration:
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07/02/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase 2 Study of CX-8998 in Adults With Tremor Associated With Parkinson's Disease
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Scientific title:
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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of CX-8998 for Tremor Associated With Parkinson's Disease |
Date of first enrolment:
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December 2019 |
Target sample size:
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0 |
Recruitment status: |
Withdrawn |
URL:
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https://clinicaltrials.gov/show/NCT03436953 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Stacey Boyer, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Jazz Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men or non-pregnant, non-breastfeeding women 40 to 80 years-of-age who are able to
read and understand English.
- Mini Mental State Exam (MMSE) score = 24.
- Clinical diagnosis of idiopathic Parkinson's disease and presence of at least 2 out of
3 cardinal characteristics (tremor, rigidity, and/or bradykinesia).
- Hoehn & Yahr Stage I III (inclusive) if not experiencing motor fluctuations. If
experiencing motor fluctuations, must be Hoehn & Yahr Stage I IV (inclusive) when OFF
or I-III (inclusive) when ON.
- An MDS-UPDRS tremor score (sum of items 2.10, 3.15, 3.16, 3.17, 3.18) of a least 10
(during ON for subjects experiencing fluctuations) (centrally rated) (Forjaz et al.,
2015). A limited number of subjects with an MDS-UPDRS of 8 or 9 may be included with
Sponsor approval.
- Treated with a stable regimen of anti-parkinsonian and/or anti-tremor medication (with
the exception of primidone) for at least 2 weeks prior to screening. Changes to
anti-parkinsonian or anti-tremor medications after screening is not permitted.
Exclusion Criteria:
- Current diagnosis of: a. essential tremor / b. cerebellar disease
- Presence or known history of: a. significant visual hallucinations (in the opinion of
the Investigator and/or Study Safety Representative) / b. significant impulse control
disorder (ICD) (in the opinion of the Investigator and/or Study Safety
Representative).
- History or clinical features consistent with an atypical parkinsonian syndrome.
- Dyskinesia or dystonia that would, in the opinion of the investigator, central rater,
or Sponsor, interfere with the assessment of tremor.
- Exposure to tremorigenic drugs or drug withdrawal states within the 30 days prior to
the first planned dose of study drug.
- Direct or indirect trauma to the nervous system within 3 months preceding the onset of
tremor.
- History or clinical evidence of psychogenic tremor origin. Known history of other
medical or neurological conditions that may cause or explain subject's tremor.
- Prior MR-guided Focused Ultrasound or surgical intervention (e.g., deep brain
stimulation, ablative thalamotomy or gamma knife thalamotomy) for treatment of tremor
or Parkinson's disease.
- Use of medication(s) in the past month that might produce tremor or interfere with the
evaluation of tremor.
- Inability to refrain from use of medication/substance(s) that might produce tremor or
interfere with the evaluation of tremor on study visit days.
- Positive urine drug screen for drugs of abuse, except if this is explained by use of
an allowed prescription medicine.
- Regular use of more than two units of alcohol per day.
- Use of prescription or non-prescription drugs or other products (i.e. grapefruit
juice) known to be strong inhibitors or inducers of CYP3A4 which cannot be
discontinued 2 weeks prior to Day 1 of dosing and withheld throughout the study.
- Concurrent illnesses that would be a contraindication to trial participation.
- Psychological, social, familial, or geographical reasons that would hinder or prevent
compliance with the requirements of the protocol or compromise the informed consent
process.
- Any other condition and/or situation that causes the Investigator or Study Safety
Representative to deem a subject unsuitable for the study (e.g., due to expected study
medication non-compliance, inability to medically tolerate the study procedures, or a
subject's unwillingness to comply with study-related procedures).
- Treatment with an investigational agent within 30 days prior to the first dose of
CX-8998 or planning to receive an investigational agent during the study.
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tremor
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Parkinson's Disease
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Intervention(s)
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Drug: Placebo
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Drug: CX-8998
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Primary Outcome(s)
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Change from Baseline to Day 28 on the MDS-UPDRS Tremor Score as scored by the central rater
[Time Frame: Baseline through completion of study treatment period, an average of 28 days]
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Secondary Outcome(s)
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Changes from baseline in QTcF
[Time Frame: Baseline through study completion, an average of 5 weeks]
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University of Miami Parkinson's disease Hallucinations Questionnaire (UM-PDHQ)
[Time Frame: Screening, Baseline and Day 28, an average of 28 days]
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Hospital Anxiety and Depression Scale (HADS)
[Time Frame: Screening and Day 28, an average of 28 days]
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Percentage of subjects who did not complete the study due to Treatment Emergent Adverse Events as assessed by CTCAE v4.0
[Time Frame: Duration of study, an average of 12 weeks]
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Percentage of subjects with Serious Adverse Events as assessed by CTCAE v4.0
[Time Frame: Duration of study, an average of 12 weeks]
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Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)
[Time Frame: Screening through study completion, an average of 8 weeks]
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Epworth Sleepiness Scale
[Time Frame: Baseline through completion of study treatment period, an average of 28 days]
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] as assessed by CTCAE v4.0
[Time Frame: Through study completion, an average of 12 weeks]
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Change from Baseline to Day 28 in accelerometry score
[Time Frame: Baseline through completion of study treatment period, an average of 28 days]
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Change from Baseline to Day 28 on the TETRAS Activity of Daily Living subscale
[Time Frame: Baseline through completion of study treatment period, an average of 28 days]
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Columbia-Suicide Severity Rating Scale (C-SSRS)
[Time Frame: Screening through study completion, an average of 8 weeks]
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Percentage of subjects with Adverse Events of Special Interest as assessed by CTCAE v4.0
[Time Frame: Duration of study, an average of 12 weeks]
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Secondary ID(s)
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CX-8998-CLN2-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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