NCT00038116

Brief Summary

The purpose of this trial is to determine if patients who received embryonic dopamine cell implant surgery showed significantly greater improvement in their Parkinson's disease than a control group undergoing the placebo treatment, and to determine if the cell implant surgery was more effective in younger or older patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3 parkinson-disease

Timeline
Completed

Started May 1995

Longer than P75 for phase_3 parkinson-disease

Geographic Reach
1 country

3 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, 1995

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2002

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 5, 2013

Status Verified

March 1, 2010

Enrollment Period

14.3 years

First QC Date

May 29, 2002

Last Update Submit

February 4, 2013

Conditions

Parkinson Disease

Keywords

Parkinson's diseasePDdopamineembryonic dopamine cell implant surgerytissue implants

Outcome Measures

Primary Outcomes (1)

  • a subjective Global Rating Scale

    duration of the trial

Secondary Outcomes (1)

  • objective measurements of PD, including UPDRS motor "off", Schwab and England "off", and 19F-fluorodopa uptake

    duration of the trial

Study Arms (2)

embryonic dopamine cell implant surgery

ACTIVE COMPARATOR

embryonic dopamine cell implant surgery

Procedure: embryonic dopamine cell implant surgery

sham surgery

PLACEBO COMPARATOR

sham surgery (placebo)

Procedure: placebo

Interventions

embryonic dopamine cell implant surgeryPROCEDURE

Half of the participants received the cell implant surgery, while the other half received the placebo. After the double-blind phase of the study, patients in the placebo group had the option of receiving tissue implants. Fourteen of these patients eventually had transplants.

embryonic dopamine cell implant surgery
placeboPROCEDURE

sham surgery

sham surgery

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's disease of at least 7 years duration and responsive to levodopa. Other Parkinson syndromes excluded.
  • Patients previously tried on other available forms of medical treatment.
  • Age between 20 and 75 years.
  • Presence of an intractable problem, such as "off" periods, dyskinesias, or "freezing," not controlled by dopamine agonists such as levodopa or pergolide.
  • No serious depression and no cognitive impairment.
  • Successful completion of home diary by patient or responsible party.
  • Successful videotape recordings at home of "on" and "off" status.
  • Normal MRI of brain within the last 18 months.
  • Fluorodopa PET scan compatible with idiopathic Parkinson's disease.
  • Medically fit to undergo implant surgery with certification by the patient's physician.
  • Able to financially cover expenses not paid for by NIH grant (between $1,000 and $2,000 for unreimbursed travel, video camera, and blood screening as specified in the consent form.

You may not qualify if:

  • Severe or moderately severe depression or cognitive impairment.
  • Previous brain surgery.
  • Presence of diabetes mellitus, severe cardiopulmonary disease or other severe medical disease, or MRI evidence of cerebrovascular disease.
  • Not medically cleared to undergo a surgical procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital, the University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

The Movement Disorder Center, Columbia-Presbyterian Hospital

New York, New York, 10032, United States

Location

Related Publications (9)

  • Freed CR, Greene PE, Breeze RE, Tsai WY, DuMouchel W, Kao R, Dillon S, Winfield H, Culver S, Trojanowski JQ, Eidelberg D, Fahn S. Transplantation of embryonic dopamine neurons for severe Parkinson's disease. N Engl J Med. 2001 Mar 8;344(10):710-9. doi: 10.1056/NEJM200103083441002.

    PMID: 11236774BACKGROUND

  • Nakamura T, Dhawan V, Chaly T, Fukuda M, Ma Y, Breeze R, Greene P, Fahn S, Freed C, Eidelberg D. Blinded positron emission tomography study of dopamine cell implantation for Parkinson's disease. Ann Neurol. 2001 Aug;50(2):181-7. doi: 10.1002/ana.1075.

    PMID: 11506400BACKGROUND

  • Ma Y, Feigin A, Dhawan V, Fukuda M, Shi Q, Greene P, Breeze R, Fahn S, Freed C, Eidelberg D. Dyskinesia after fetal cell transplantation for parkinsonism: a PET study. Ann Neurol. 2002 Nov;52(5):628-34. doi: 10.1002/ana.10359.

    PMID: 12402261BACKGROUND

  • Trott CT, Fahn S, Greene P, Dillon S, Winfield H, Winfield L, Kao R, Eidelberg D, Freed CR, Breeze RE, Stern Y. Cognition following bilateral implants of embryonic dopamine neurons in PD: a double blind study. Neurology. 2003 Jun 24;60(12):1938-43. doi: 10.1212/01.wnl.0000070181.28651.3b.

    PMID: 12821736BACKGROUND

  • Bjorklund A, Dunnett SB, Brundin P, Stoessl AJ, Freed CR, Breeze RE, Levivier M, Peschanski M, Studer L, Barker R. Neural transplantation for the treatment of Parkinson's disease. Lancet Neurol. 2003 Jul;2(7):437-45. doi: 10.1016/s1474-4422(03)00442-3. No abstract available.

    PMID: 12849125BACKGROUND

  • Freed CR, Leehey MA, Zawada M, Bjugstad K, Thompson L, Breeze RE. Do patients with Parkinson's disease benefit from embryonic dopamine cell transplantation? J Neurol. 2003 Oct;250 Suppl 3:III44-6. doi: 10.1007/s00415-003-1308-5.

    PMID: 14579124BACKGROUND

  • Gordon PH, Yu Q, Qualls C, Winfield H, Dillon S, Greene PE, Fahn S, Breeze RE, Freed CR, Pullman SL. Reaction time and movement time after embryonic cell implantation in Parkinson disease. Arch Neurol. 2004 Jun;61(6):858-61. doi: 10.1001/archneur.61.6.858.

    PMID: 15210522BACKGROUND

  • McRae C, Cherin E, Yamazaki TG, Diem G, Vo AH, Russell D, Ellgring JH, Fahn S, Greene P, Dillon S, Winfield H, Bjugstad KB, Freed CR. Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial. Arch Gen Psychiatry. 2004 Apr;61(4):412-20. doi: 10.1001/archpsyc.61.4.412.

    PMID: 15066900BACKGROUND

  • Ma Y, Tang C, Chaly T, Greene P, Breeze R, Fahn S, Freed C, Dhawan V, Eidelberg D. Dopamine cell implantation in Parkinson's disease: long-term clinical and (18)F-FDOPA PET outcomes. J Nucl Med. 2010 Jan;51(1):7-15. doi: 10.2967/jnumed.109.066811. Epub 2009 Dec 15.

    PMID: 20008998RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Curt R. Freed, M.D.

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2002

First Posted

May 30, 2002

Study Start

May 1, 1995

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

February 5, 2013

Record last verified: 2010-03

Locations

US(3)