The Effects of Aplindore on the Treatment of Signs and Symptoms of Parkinson's Disease

NCT00623324 | Completed Phase 2

• 1 other identifier: Aplindore-201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate the safety, tolerability, efficacy and pharmacokinetics of aplindore in patients with early stage Parkinson's Disease (PD) who are not currently taking any dopamine agonists or who are able to wash off dopamine agonists for 14 days prior to baseline. Efficacy will be assessed using the UPDRS questionnaire including part 3 of the UPDRS (Motor). their level of sleepiness on a standardized rating scale (Epworth Sleepiness Scale) and their level of nausea daily. Safety endpoints will include adverse events (AEs), clinical laboratory data, vital signs (blood pressure, orthostatic blood pressure and heart rate), ECGs, physical examinations and self rated scales.

Conditions

Early Stage Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Evaluation of safety and tolerability data

  3 weeks

Secondary Outcomes (1)

• Change in UPDRS Motor (Part III) score, UPDRS Activities of Daily Living (ADL; Part II), the Non-Motor Symptoms Questionnaire, and the Epworth Sleepiness Scale (ESS) and nausea Likert Scale.

  3 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Aplindore titrated to safe and tolerable dose

Drug: Aplindore

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Aplindore DRUG

Tablets .05 - 5 mg BID dosing for 14 days

1

Placebo DRUG

Placebo tablets to match the number of active tablets

2

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 30 years and above
• Must carry a diagnosis of idiopathic Parkinson's disease (PD), without any other known or suspected cause of parkinsonism, according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
• For early stage patients the initial diagnosis of PD must have been made within the 5 years prior to Screening with at least two or more of the following cardinal signs being present: bradykinesia, resting tremor, rigidity, and postural instability. In addition, they must not have developed motor complications from L-dopa use
• Early stage patients must be modified Hoehn \& Yahr Stage 1 to 3 (inclusive)
• Must have a screening UPDRS (Part III) motor score of at least 10 Patients may be receiving amantadine, anticholinergics, COMT inhibitors and/or MAO-B inhibitor provided the dose was stable for at least 4 weeks prior to screening; dopamine agonists and/or L-dopa/carbidopa are permitted at screening but must be discontinued at least 14 days before baseline
• Good general health as determined by a thorough medical history and physical examination (including vital signs), 12-lead ECG and clinical laboratory tests
• Patients have clinical laboratory values within normal reference range or must not be clinically significantly abnormal as judged by the Investigator and approved by the Sponsor
• Patients taking prescription drug therapy or OTC medication for chronic medical conditions must be on stable doses for at least two (2) weeks prior to participation in the study and off any investigational drug for at least 60 days
• Females of childbearing potential must be using an acceptable method of contraception, have a negative urine pregnancy test at screening, and a negative urine pregnancy test on admission. Acceptable methods of contraception are oral, intrauterine, implantable, injectable contraceptives, double barrier methods or condoms impregnated with spermicide. After screening, patients using oral contraceptive methods of contraception must agree to add an additional method until 30 days following the last dose of study medication. Women on oral contraceptives must have been using them for at least one month prior to screening
• Male patients with partners of childbearing potential must use adequate contraception for 3 months after the study
• Female patients who have been surgically sterilized or have had a partial oopherectomy (i.e., one ovary intact) are eligible if they have a negative pregnancy test at screening and admission Be able to read, understand, and provide written/dated informed consent before enrolling in the study, and must be willing to comply with all study procedures;
• Patients must be willing and able to be confined to the clinical research unit as required by the protocol
• Patients must refrain from strenuous physical activity beginning 24 hours prior to screening and through the duration of the study
• Smokers may be enrolled if they have stable smoking habits

You may not qualify if:

• A Mini Mental State Examination (MMSE) score \< 26
• History or clinical features consistent with an atypical parkinsonian syndrome
• History of surgical intervention for PD
• History of L-dopa-induced motor or non-motor complication
• History of severe allergic or anaphylactic reactions to any drug
• Clinically significant abnormal baseline ECG; QTcF \> 450 msec for males, \> 470 msec for females
• Recent history of severe dizziness or fainting due to postural hypotension; orthostatic blood pressure decrease defined as a drop in systolic BP of ≥ 40 mmHg and or a drop in diastolic BP of ≥ 20 mmHg following 5 minutes supine and 2 minutes standing in conjunction with symptoms.
• Evidence of clinically significant unstable allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurological disease
• History of cancer within 5 years of screening; except basal and squamous cell skin cancers and carcinoma in situ of the cervix
• Any condition that may affect drug absorption
• History of allergies, or known sensitivity, hypersensitivity, or adverse reaction to any drug similar to aplindore
• Pregnant or lactating females
• Recent history or current evidence of drug abuse or alcoholism; or withdrawal
• Introduction or dose change of hormone replacement therapy within 3 months

Sponsors & Collaborators

• Ligand Pharmaceuticals: lead

Study Sites (1)

Miami Research Associates

Miami, Florida, 33143, United States

Location

MeSH Terms

Interventions

aplindore fumarate

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 26, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2008
• Last Updated: October 3, 2011

Record last verified: 2011-09

Locations

US (1)